Chapter:

138A

PHARMACY AND POISONS REGULATIONS

Gazette Number Version Date

30/06/1997

Empowering section
(Cap 138, section 29)

[1 July 1978] L.N. 145 of 1978

(Originally L.N. 163 of 1975)
Part:

Regulation: 1

PRELIMINARY

30/06/1997

Citation

30/06/1997

These regulations may be cited as the Pharmacy and Poisons Regulations.

Regulation: 2

Interpretation

L.N. 30 of 2015

06/02/2015

(1) In these regulations, unless the context otherwise requires"antimonial poisons" () means organic and inorganic compounds of antimony;
"arsenical poisons" () means organic and inorganic compounds of arsenic;
authorized person () means a person whose name is entered in the register of authorized persons; (2 of
2015 s. 32)
"British Pharmaceutical Codex" ( ), "British Pharmacopoeia" ( ), "British National
Formulary" () and "British Veterinary Codex" () include the supplements
thereto;
"food" () includes a beverage;
GMP Guide () means the Good Manufacturing Practice Guide issued under regulation 28A as revised from
time to time under that regulation; (2 of 2015 s. 32)
"medicine for the internal treatment of human and animal ailments" ()
includes any medicine to be administered by injection, but does not include any mouth-wash, eye-drops, eyelotion, ear-drops, nasal drops, douche or similar article;
register of authorized persons () means the register of authorized persons kept under regulation 30B;
(2 of 2015 s. 32)
specified form (), in relation to a purpose under these regulations, means the form specified for that purpose
under regulation 38B; (2 of 2015 s. 32)
"Tribunal" () means the Pharmacy and Poisons Appeal Tribunal established by section 30 of the Ordinance;
(L.N. 369 of 1980)
"veterinary institution" ( ) means a veterinary hospital, veterinary clinic or other premises where sick
animals are treated.
(2) In these regulations any reference to an alkaloid shall include a reference to any salt of that alkaloid, and, in
a case where the esters of an alkaloid are included in the Poisons List by virtue of the words "its esters", to any esters
of that alkaloid.
(3) Any reference in the Schedules to these regulations to the percentage of a poison contained in any substance
or preparation shall, unless otherwise expressly provided, be construed in the following manner, that is to say, a
reference to a substance or preparation containing 1 per cent of any poison means(a) in the case of a solid, that 1 gramme of the poison is contained in every 100 grammes of the substance
or preparation;
(b) in the case of a liquid, that 1 millilitre of the poison, or, if the poison itself is a solid, 1 gramme of the
poison, is contained in every 100 millilitres of the substance or preparation,

Cap 138A - PHARMACY AND POISONS REGULATIONS

and so in proportion for any greater or less percentage.

(4) Substances listed in Divisions A in the Schedules to these regulations are those whose uses are essentially
medicinal, whilst substances listed in Divisions B are not normally used medicinally. (L.N. 41 of 2007)
(5) Where in these regulations reference is made to a numbered section the reference shall be a reference to that
section of the Ordinance. (L.N. 41 of 2007)
(6) Where functions are conferred on a committee by any provision of these regulations, references in such
provision to "the Committee" shall be construed as references to the executive committee established under section 4A
of the Ordinance for the purpose of performing such functions. (L.N. 369 of 1980)
Regulation: 2A

Poisons List

L.N. 30 of 2015

06/02/2015

The Poisons List is set out in Schedule 10.

(2 of 2015 s. 33)
Regulation: 3

Application of section 22 restricted to the First Schedule

L.N. 30 of 2015

06/02/2015

Section 22 shall only apply to those poisons included in Part I of the Poisons List which are also included in the
First Schedule but not included in the Third Schedule.
(L.N. 202 of 1999; 2 of 2015 s. 34)
Regulation: 4

30/06/1997

Extension of labelling provisions and relaxation with

respect to poisons in the Sixth Schedule

Expanded Cross Reference:

12, 13, 14, 15, 16, 17

(1) Subject to paragraph (2), the provisions of section 27 and regulations 12 to 17 (which provisions relate to
the labelling of poisons) shall apply to sales exempted by section 32, and shall also apply to the supply of poisons
(otherwise than on sale) and references in those provisions to the sale and the seller of poisons shall be deemed to refer
to the supply and the supplier of poisons respectively. <*Note-Exp. x-Ref: Regulations 12, 13, 14, 15, 16 ,17 *>
(2) In the case of the sale or supply of any of the poisons included in the Sixth Schedule to a person who(a) carries on a business in the course of which poisons are regularly sold by way of wholesale dealing or
are regularly used in the manufacture of other articles; and
(b) requires the poison for the purpose of that business,
if the outside of the package in which the poison is sold or supplied is labelled conspicuously with words indicating
the dangerous properties of the poison, it shall be necessary to comply only with regulation 15 and section 27(a) and
section 27(d) (as modified by regulation 17).
Regulation: 5

Extension of section 22 to sales wholesale etc. and

relaxation of the section

L.N. 30 of 2015

06/02/2015

(1) Section 22 shall apply to sales exempted by section 32, except sales of poisons to be exported to purchasers
outside Hong Kong, and shall also apply to the supply in the form of a commercial sample, otherwise than on sale, of
any substance included in the First Schedule in like manner as if references in section 22 to the sale and seller of
poisons respectively included references to the supply and the supplier of poisons in the form of commercial samples:
Provided that section 22 shall not apply to the sale or supply of any article by the licensed manufacturer thereof
or by a person carrying on a business in the course of which poisons are regularly sold by way of wholesale dealing,
if- (2 of 2015 s. 35)
(a) the article is sold or supplied to a person carrying on a business in the course of which poisons are
regularly sold or are regularly used in the manufacture of other articles; and
(b) the seller or supplier is reasonably satisfied that the purchaser requires the article for the purpose of
that business.
(2) Section 22(1) shall, in its application to sales exempted by section 32 and to the supply in the form of
commercial samples of substances included in the First Schedule, be deemed to be satisfied if the person to whom the

Cap 138A - PHARMACY AND POISONS REGULATIONS

poison or sample is sold or supplied is known by the person in charge of the department of the business through which
the sale or supply is effected to be a person to whom the poison or sample may properly be sold or supplied.
(3) Subject to paragraph (4), so much of section 22(3)(b) as requires an entry in the poisons book to be signed
by the purchaser of a poison shall not, as respects the sale of a poison to a person for the purpose of his trade, business
or profession, apply if the following requirements are satisfied(a) the seller shall obtain before the completion of the sale an order in writing signed by the purchaser
stating his name and address, trade, business or profession, the name and quantity of the article to be
purchased, and the purpose for which it is required;
(b) the seller shall be reasonably satisfied that the signature is that of the person purporting to have signed
the order, and that that person carries on the trade, business or profession stated in the order, being one
in which the poison to be purchased is used; and
(c) if the article sold is sent by post, it shall be sent by registered post.
(4) Where a person represents that he urgently requires a poison for the purpose of his trade, business or
profession, the seller may, if he is reasonably satisfied that the person so requires the poison and is, by reason of some
emergency, unable before delivery either to furnish to the seller an order in writing duly signed or to attend and sign
the entry in the book, deliver the poison to the purchaser on an undertaking by the purchaser to furnish such an order
within 48 hours next following.
(5) Any purchaser by whom an undertaking under paragraph (4) has been given who fails to deliver to the
seller a signed order in accordance with the undertaking, or any person who for the purpose of obtaining delivery of
any poison makes a statement which is to his knowledge false in any material particular shall be guilty of an offence
and shall be liable on conviction to a fine of at level 3 and to imprisonment for 12 months. (2 of 2015 s. 35)
(6) In the case of a sale or the supplying of a poison included in the First Schedule to an institution such of the
provisions of this regulation as require the purchaser to state his trade, business or profession and the seller to be
satisfied with respect thereto shall not apply and for the reference in paragraph (4) to the purposes of the purchaser's
trade, business or profession there shall be substituted in the case of any such sale a reference to the name of the
institution and the full name and rank or position held at the institution of the person making the order.
Regulation: 6

30/06/1997

Relaxation of section 28(3) in the case of certain medicines

The requirements of section 28(3) (which requires particulars of medicines supplied or dispensed under that
section to be entered in a book) shall be satisfied in respect of medicines included in the First Schedule, but need not
be satisfied in respect of other medicines which are supplied by(a) a registered medical practitioner for the purposes of medical treatment; or
(b) an authorized seller of poisons on and in accordance with a prescription given by a registered medical
practitioner.
Regulation: 7

30/06/1997

Exemption from the provisions relating solely to the First

Schedule

The provisions of these regulations and of the Ordinance (as modified by these regulations) which apply solely
to the substances in the First Schedule shall not apply to(a) machine-spread plasters;
(b) surgical dressings;
(c) (Repealed L.N. 262 of 1995)
(d) corn paints in which the only poison is a poison included in the Poisons List under the heading
"Cannabis".
Regulation: 8

Complete exemption for articles and substances in the

Second Schedule

L.N. 30 of 2015

06/02/2015

(1) Subject to paragraph (2), nothing in the Ordinance or these regulations shall apply(a) to any article in Group I of the Second Schedule; or
(b) to any of the articles or substances specified in the second column of Group II of the Second Schedule
opposite the description of the poison specified in the first column thereof. (L.N. 85 of 1987)
(2) Notwithstanding paragraph (1)(b), Parts VI, VII, VIII, IX and X of these regulations shall apply to every
Cap 138A - PHARMACY AND POISONS REGULATIONS

article or substance referred to in that paragraph, that is a pharmaceutical product within the meaning of the
Ordinance. (L.N. 85 of 1987; 2 of 2015 s. 36)
Part:

II

Regulation: 9

ADDITIONAL RESTRICTIONS ON THE SALE OF

POISONS
Additional restriction of sale of poisons in the Third
Schedule

30/06/1997

96 of 1997; L.N. 15/01/1999

3 of 1999

(1) No person shall sell any poison included in the Third Schedule, except on and in accordance with a
prescription given by a registered medical practitioner, registered dentist or registered veterinary surgeon. (L.N. 614
of 1997)
(2) This regulation shall apply to the sale of any such poison, including a medicine exempted by section 28, but
shall not apply to any sale exempted by section 32.
(3) For the purposes of this regulation a prescription shall(a) be in writing and be signed by the person giving it with his usual signature and be dated by him;
(b) specify the address of the person giving it;
(c) specify the name and address of the person for whose treatment it is given or, if the prescription is
given by a registered veterinary surgeon, of the person to whom the medicine is to be delivered; (L.N.
614 of 1997)
(d) have written thereon, if given by a dentist, the words "For dental treatment only ",
or, if given by a registered veterinary surgeon, the words "For animal treatment only
"; and (L.N. 614 of 1997)
(e) indicate the total amount of the medicine to be supplied and the dose to be taken or administered.
(4) The person dispensing the prescription shall comply with the following requirements(a) the prescription shall not be dispensed more than once unless the prescriber has directed either(i) that it may be dispensed a stated number of times; or
(ii) that it may be dispensed at stated intervals;
(b) if the prescription contains a direction that it may be dispensed a stated number of times or at stated
intervals, it shall not be dispensed otherwise than in accordance with the direction;
(c) at the time of dispensing there shall be noted on the prescription above the signature of the prescriber
the name and address of the seller and the date on which the prescription is dispensed; and
(d) except in the case of a prescription which may be dispensed again, the prescription shall, for a period
of 2 years, be retained and kept on the premises on which it was dispensed in such manner as to be
readily available for inspection.
Regulation: 10

Restriction of sales by listed sellers of poisons

30/06/1997

No listed seller of poisons shall sell any poison other than a solution of ammonia, hydrochloric acid, nitric acid,
potassium quadroxalate or sulphuric acid, except in a closed container as closed by the manufacturer or other person
from whom the poison was obtained.
Regulation: 10A

Prohibition on dispensing of prescriptions by listed sellers

of poisons

30/06/1997

No listed seller of poisons shall dispense any prescription for medicine.

(L.N. 85 of 1987)
Regulation: 11

Restriction of sale of strychnine

96 of 1997; L.N. 15/01/1999

3 of 1999

(1) No person shall sell or supply strychnine except as an ingredient in a medicine.

(2) This regulation shall extend to transactions exempted by section 32, but shall not apply to the sale of

Cap 138A - PHARMACY AND POISONS REGULATIONS

strychnine(a) by way of wholesale dealing;

(b) to be exported to purchasers outside Hong Kong;
(c) for the purpose of being compounded in medicines prescribed or administered by a registered medical
practitioner or registered veterinary surgeon; or (L.N. 614 of 1997)
(d) to a person or institution concerned with education, scientific research or chemical analysis, for the
purpose of that education, research or analysis.
Part:

III

SUPPLEMENTARY PROVISIONS WITH RESPECT TO L.N. 30 of 2015

LABELLING AND CONTAINERS OF POISONS*

06/02/2015

________________________________________________________________________________
Note:
* (2 of 2015 s. 73)

Regulation: 12

Manner of labelling containers

30/06/1997

Expanded Cross Reference:

13, 14, 15, 16, 17

(1) Subject to paragraphs (2) and (3), the particulars with which the container of a poison is required to be
labelled under section 27 and under these regulations, shall appear in a conspicuous position on the container in which
the poison is sold and on every box or other covering of whatever nature enclosing the container, and the particulars
shall be clearly and distinctly set out and not in any way obscured or obliterated.
(2) Where the poison is contained in a cachet or similar article it shall not be necessary to label the article itself,
if every box or other covering in which the article is enclosed is labelled in accordance with paragraph (1).
(3) Nothing in section 27 or in this regulation or regulations 13 to 17 shall be deemed to require the labelling of
any transparent cover or any wrapper, hamper, packing case, crate or other covering used solely for the purposes of
transport or delivery. <*Note-Exp. x-Ref: Regulations 13, 14, 15, 16, 17 *>
Regulation: 13

Labelling of name of poison

30/06/1997

(1) For the purposes of section 27(a) and regulation 22(3)(a), the name of a poison shall be the term under
which it is included in the Poisons List:
Provided that, where the term describes a group of poisons and not the poison specifically, the name of the
poison shall be(a) if the poison is the subject of a monograph in either the British Pharmacopoeia, the British
Pharmaceutical Codex or the British Veterinary Codex, one of the names or synonyms or abbreviated
names set out at the head of the monograph; or
(b) in any other case, the accepted scientific name or the name descriptive of the true nature and origin of
the poison.
(2) For the purposes of the proviso to paragraph (1), where(a) a substance is the subject of a monograph in the British Pharmacopoeia, the British Pharmaceutical
Codex or the British Veterinary Codex, or any dilution, concentration or admixture of such substance;
or
(b) a preparation is contained in the British Pharmacopoeia, the British Pharmaceutical Codex, the British
National Formulary or the British Veterinary Codex, or any dilution, concentration or admixture of
such preparation; or
(c) a surgical dressing of a type for which a standard is prescribed in the British Pharmaceutical Codex,
it shall be sufficient to state the name, synonym or abbreviated name used to describe the substance, preparation or
surgical dressing with the addition of the letters B.P., B.P.C., B.N.F. or B. Vet.C., as the case may be.
Regulation: 14

Labelling of particulars as to proportions of the poison

30/06/1997

For the purpose of section 27(b) (which requires preparation containing poisons to be labelled with particulars as

Cap 138A - PHARMACY AND POISONS REGULATIONS

to the proportion of each poison therein)(a) in the case of a preparation containing a poison specified in the first column of the Fourth Schedule, it
shall be sufficient to state on the label the particulars specified in the second column of that Schedule
against the description of the poison;
(b) in the case of a substance, preparation or surgical dressing which is named in accordance with
regulation 13(2), it shall not be necessary to state on the label the proportion of the poison contained in
the substance, preparation or surgical dressing, and in the case of any dilution, concentration or
admixture of such substance or preparation it shall be sufficient to state the proportion which the
substance or preparation bears to the total ingredients of that dilution, concentration or admixture;
(c) where the poison is in tablets, pills, cachets, capsules, lozenges or similar articles, it shall be sufficient
to state on the label of the box or other covering in which the articles are enclosed the number of the
articles and the amount of the poison, or in the case of a preparation or substance mentioned in
paragraph (b), the amount of the preparation or substance, contained in each article;
(d) where the poison is in ampoules it shall be sufficient to show the name of the poison contained in it
together with, either its concentration (if in solution or in emulsified form), or the quantity (if in solid
form); and
(e) where any proportion is stated as a percentage, the statement shall indicate whether the percentage is
calculated on the basis of weight in weight, weight in volume, or volume in volume.
Regulation: 15

"Poison" to be in English and Chinese

30/06/1997

(1) The word "poison" or other statement as specified in the Fifth Schedule with which a container of a poison
is required to be labelled pursuant to section 27(c) shall be printed clearly in both English and Chinese.
(2) The container of any article specified in the Fifth Schedule shall, instead of being labelled with the word
"Poison " be labelled with the words specified in that Schedule as applicable to that article.
(3) The words referred to in paragraph (2) or the word "Poison ", as the case may be, shall not be
modified in meaning by the addition of any other words or marks, and(a) in the case of a substance included in the First Schedule, shall either be in red lettering or be set against
a red background; and
(b) in all cases shall either be on a separate label or be surrounded by a line within which there shall be no
other words except words with which the container of the poison is required to be labelled under the
Ordinance or these regulations.
(L.N. 137 of 1978)
Regulation: 16

Special precautions in the case of certain articles

30/06/1997

(1) No person shall sell or supply any poison(a) in the case of a liquid other than a medicine, in a container of a capacity of not more than 2 litres,
unless the container is labelled with the words "Not to be taken "; and
(b) in the case of an embrocation, liniment, lotion, liquid antiseptic, or other liquid medicine for external
application, unless the container is labelled with the type of preparation and the words "For external
use only ". (L.N. 137 of 1978)
(2) No person shall sell or supply any compressed hydrocyanic acid, unless the container thereof is labelled
with the words "Warning. This container holds poisonous gas and should only be opened and used by persons having
expert knowledge of the precautions to be taken in its use.
.".
(3) This regulation shall be in addition to the other requirements of the Ordinance and of these regulations with
respect to labelling and shall apply to the transactions referred to in sections 28 and 32, but shall not apply to the sale
or supply of poisons to be exported to purchasers outside Hong Kong.
(L.N. 22 of 1982)

Cap 138A - PHARMACY AND POISONS REGULATIONS

Regulation: 17

30/06/1997

Name of seller and address of premises

(1) Section 27(d) (which requires the container of a poison to be labelled with the name of the seller and the
address of the premises on which it was sold) shall apply to the transactions referred to in section 32, but shall not
apply(a) in the case of an article sold for the purpose of being sold again in the same container; or
(b) to poisons to be exported to purchasers outside Hong Kong.
(2) The requirements of section 27(d) shall be deemed to be satisfied, in the case of a poison supplied from a
warehouse or depot, if the container of the poison is labelled with the address of the supplier's principal place of
business.
(3) Where any poison (other than a substance included in the First Schedule) is sold in a container and outer
covering, being the container and covering in which it was obtained by the seller, it shall be sufficient if the name of
the seller and the address of the premises on which it was sold appear only on the outer covering.
(4) Where the names of more than one person or more than one address appear on any label, there shall also be
words on the label indicating clearly which person is the seller and at which of the addresses the poison was sold.
Regulation: 18

Form of containers of poisons*

L.N. 30 of 2015

06/02/2015

(1) No person shall sell, whether wholesale or retail, or supply any poison unless(a) it is contained in a container impervious to the poison and sufficiently stout to prevent leakage arising
from the ordinary risks of handling and transport; and
(b) in the case of a liquid contained in a glass bottle or plastic container containing not more than 2 litres,
not being a medicine made up ready to be taken for the internal treatment of human or animal ailments,
the outer surface of the bottle or container is fluted vertically with ribs or grooves recognizable by
touch. (L.N. 22 of 1982)
(2) Paragraph (1)(a) shall apply to the transactions referred to in section 28, and paragraph (1)(b) shall apply to
the transactions exempted by section 32 but shall not apply to the sale or supply of poisons to be exported to
purchasers outside Hong Kong.
________________________________________________________________________________
Note:
* (2 of 2015 s. 73)

Part:

IV

STORAGE AND TRANSPORT OF POISONS*

L.N. 30 of 2015

06/02/2015

________________________________________________________________________________
Note:
* (2 of 2015 s. 73)

Regulation: 19

Storage of poisons

L.N. 30 of 2015

06/02/2015

(1) No person shall store any poison except in a container impervious to the poison and sufficiently stout to
prevent leakage from the container arising from the ordinary risks of handling.
(2) No person shall store any poison included in Part I of the Poisons List in any retail shop or premises used in
connection therewith unless the substance is stored- (2 of 2015 s. 38)
(a) in a receptacle reserved solely for the storage of poisons, which receptacle shall be locked with an
adequate lock the key for which shall be retained by the registered pharmacist; and (L.N. 197 of 1989;
L.N. 366 of 1995)
(b) in a part of the premises to which customers are not permitted to have access and which is partitioned
off or otherwise separated from the remainder of the premises.
(3) No food shall be stored in the part of the premises where such poison is stored. (2 of 2015 s. 38)
Regulation: 20

Transport of poisons

30/06/1997

No person shall consign any poison for transport unless it is sufficiently stoutly packed to avoid leakage arising
from the ordinary risks of handling and transport.

Cap 138A - PHARMACY AND POISONS REGULATIONS

Regulation: 21

30/06/1997

Special provisions with respect to the transport of poisons

in the Seventh Schedule

(1) No person shall consign for transport by carrier any poison included in the Seventh Schedule unless the
outside of the package containing the article is labelled conspicuously with the name or description of the poison as set
forth in that Schedule and a notice indicating that it is to be kept separate from food and from empty containers in
which food has been contained.
(2) No person shall knowingly transport any poison included in the Seventh Schedule, either on his own behalf
or for another person, in any vehicle in which food is being transported, unless the food is carried in a part of the
vehicle effectively separated from that containing the poison, or is otherwise adequately protected from the risk of
contamination.
(3) This regulation shall not apply to medicines.
Part:

SPECIAL PROVISIONS WITH RESPECT TO

INSTITUTIONS

Regulation: 22

Supply of medicines to out-patients from certain

institutions, etc.

30/06/1997

L.N. 30 of 2015

06/02/2015

(1) Nothing in the Ordinance or in these regulations, except regulation 16 and this Part, shall apply with respect
to- (L.N. 262 of 1995)
(a) any medicine dispensed in an institution where the dispensing is under the supervision of a registered
pharmacist or other person as may be approved by the Director of Health; or (L.N. 76 of 1989)
(b) any medicine for the treatment of animals supplied from a veterinary institution which is under the
superintendence of a registered veterinary surgeon, (L.N. 614 of 1997)
if the requirements of this regulation are satisfied in relation thereto.
(2) The medicine shall not be supplied except by, or on and in accordance with a prescription of, a duly
registered medical practitioner for the purposes of medical treatment, or a registered dentist for the purposes of dental
treatment, or a registered veterinary surgeon for the purposes of animal treatment. (L.N. 614 of 1997)
(3) In a case where a substance included in the First Schedule is supplied, a record shall be kept on the
premises in such a way that there can readily be traced at any time during a period of 2 years after the date on which
the substance was supplied the following particulars(a) the name and quantity of the poison supplied;
(b) the date on which the poison was supplied;
(c) the name and address of the person to whom the poison was supplied; and
(d) the name of the person who supplied the poison or who gave the prescription upon which it was
supplied.
(4) The container of the medicine shall be labelled(a) with a designation sufficient to identify the institution or veterinary institution from which it was
supplied; and (L.N. 137 of 1978; 2 of 2015 s. 39)
(b) (Repealed 2 of 2015 s. 39)
(c) in the case of a poison supplied from a veterinary institution, with the words "For animal treatment
only ".
(5) The medicine shall be clearly labelled with instructions for use in either English or Chinese. (2 of 2015 s.
39)
(6) In the case of a medicine to which regulation 16 applies the requirements of that regulation shall be satisfied
in addition to the requirements of this regulation.
Regulation: 23

Supply of medicines for use in institutions, etc.

L.N. 30 of 2015

06/02/2015

(1) In any institution in which medicines are dispensed in a dispensing or pharmaceutical department in charge
of a registered pharmacist or any other person approved by the Director of Health for that purpose, no medicine

Cap 138A - PHARMACY AND POISONS REGULATIONS

containing a poison shall be supplied from that department, except in cases of emergency, for use in the wards,
operating theatres or other sections of the institution, except in accordance with paragraphs (2) and (3). (L.N. 76 of
1989)
(2) Subject to paragraph (4), the medicines shall not be supplied except upon a written order signed by a duly
registered medical practitioner, registered dentist, or by a person authorized to be in charge of a ward, theatre or other
section of the institution.
(3) The container of the medicine shall be labelled with words describing its contents. (2 of 2015 s. 40)
(4) In the case of an emergency, a medicine containing a poison may be supplied without a written order if the
person ordering the medicine undertakes to furnish a written order in respect of that medicine within the next 24
hours.
Regulation: 24

Storage of poisons in institutions

L.N. 30 of 2015

06/02/2015

(1) In any institution in which medicines are dispensed in a dispensing or pharmaceutical department in the
charge of a person appointed for the purpose, all poisons other than those issued for use within the institution shall be
stored in that department.
(2) In any institution to which paragraph (1) does not apply all poisons other than those issued for use within
the institution shall be stored(a) in the charge of a person appointed for the purpose by the governing body or person in control of the
institution; and
(b) in the case of substances included in the First Schedule either in a cupboard or drawer, or on a shelf,
reserved for the storage of poisons. (2 of 2015 s. 41)
(3)-(4)
(Repealed 2 of 2015 s. 41)
(5) All places in which poisons are required by this regulation to be stored shall be inspected at regular
intervals of time not exceeding three months by a registered pharmacist or registered medical practitioner appointed
for the purpose by the governing body of the institution and a record of all inspections shall be made in a book kept at
the institution.
Part:

VA

30/06/1997

LISTED SELLERS OF POISONS

(Part VA added L.N. 369 of 1980)

Regulation: 24A

Applications to be entered on list under section 25

L.N. 30 of 2015

06/02/2015

(1) Any application under section 25(1) shall be made in writing to the Committee and shall be accompanied
by the fee specified in the Ninth Schedule.
(2) The Committee may grant or refuse any application under this regulation and shall notify the applicant of
its decision:
Provided that if the Committee intends to refuse an application the Committee shall first notify the applicant and
the applicant may, not later than 14 days after the date of such notification, submit representations in writing to the
Committee in support of his application.
(3) Where the Committee grants an application under this regulation the Committee shall notify the Board of
its decision and shall state whether the applicant has paid the prescribed fee.
(4) Any applicant aggrieved by a decision made in respect of the applicant under this regulation may, in the
prescribed manner, appeal to the Tribunal against that decision. (2 of 2015 s. 42)
Part:

VB

REGISTRATION OF PREMISES OF AUTHORIZED

SELLERS OF POISONS*

L.N. 30 of 2015

06/02/2015

________________________________________________________________________________
Note:
* (2 of 2015 s. 73)

Cap 138A - PHARMACY AND POISONS REGULATIONS

Regulation: 24B

Applications to register premises under section 13

L.N. 30 of 2015

06/02/2015

An application to register premises under section 13 shall be(a) (Repealed 2 of 2015 s. 43)
(b) submitted together with a copy of the certificate of registration of the registered pharmacist by whom
or in whose presence and under whose supervision the actual sale of poisons will be conducted under
section 11(1) of the Ordinance. (2 of 2015 s. 43)
(L.N. 85 of 1987)
Regulation: 24C

(Repealed 2 of 2015 s. 44)

L.N. 30 of 2015

06/02/2015

Part:

WHOLESALE DEALING IN POISONS AND

PHARMACEUTICAL PRODUCTS*

L.N. 30 of 2015

06/02/2015

VI

________________________________________________________________________________
Note:
* (2 of 2015 s. 73)

Regulation: 25

Sale and supply of poisons or pharmaceutical products

wholesale

L.N. 30 of 2015

06/02/2015

A person must not, by way of wholesale dealing, sell or supply at or from any premises a pharmaceutical product, or a
substance or article consisting of or containing any poison, unless the person
(a) holds a wholesale dealer licence issued to the person by the Committee in respect of those premises;
(b) is an authorized seller of poisons; or
(c) is a licensed manufacturer selling or supplying only pharmaceutical products manufactured by the licensed
manufacturer.
(2 of 2015 s. 45)
Regulation: 26

Pharmacy and Poisons (Wholesale Licences) Committee

L.N. 30 of 2015

06/02/2015

(1) There shall be for the purposes of this Part a Committee to be called the Pharmacy and Poisons (Wholesale
Licences) Committee.
(2) (Repealed L.N. 369 of 1980)
(3) The Committee may, subject to any conditions it thinks fit to impose, issue a wholesale dealer licence on
payment of the fee prescribed in the Ninth Schedule.
(4) The issue of a wholesale dealer licence shall be at the discretion of the Committee and shall be in the
specified form.
(5) In any of the circumstances specified in paragraph (5A), the Committee may
(a) revoke a wholesale dealer licence or suspend it for a period it thinks fit;
(b) issue a warning letter to the licensed wholesale dealer; or
(c) vary a condition of the licence imposed under paragraph (3). (2 of 2015 s. 46)
(5A) The circumstances are
(a) that, in the Committees opinion, the licensed wholesale dealer has contravened
(i) a condition of the licence; or
(ii) any of these regulations or a code of practice applicable to the licensed wholesale dealer; or
(b) that the licensed wholesale dealer has been convicted of
(i) an offence under the Ordinance or any of the regulations made under section 29, the Dangerous Drugs
Ordinance (Cap 134), the Antibiotics Ordinance (Cap 137) or the Undesirable Medical Advertisements
Ordinance (Cap 231); or
(ii) an offence under section 6C or 6D of the Import and Export Ordinance (Cap 60), section 52, 54 or 61
of the Public Health and Municipal Services Ordinance (Cap 132) or section 7, 7A or 9 of the Trade
Descriptions Ordinance (Cap 362). (2 of 2015 s. 46)

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10

(5B) The Committee may, subject to any conditions it thinks fit to impose, suspend for a period not exceeding 3 years
(suspension period) the operation of a decision made under paragraph (5)(a) so that the decision takes effect
only if a condition so imposed is contravened during the suspension period, and in the case of such a
contravention, the decision takes effect on the date specified by the Committee having regard to all the
circumstances of the case. (2 of 2015 s. 46)
(6) Any applicant or licensed wholesale dealer aggrieved by a decision of the Committee under this regulation
may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980)
(7) (Repealed L.N. 369 of 1980)
(8) An applicant for a wholesale dealer licence- (2 of 2015 s. 46)
(a) shall nominate in writing a responsible person to be in charge of the poisons or pharmaceutical
products; and
(b) may nominate in writing one or more deputies to act during the temporary absence of the responsible
person.
(9) An applicant shall at the time of his application submit to the Secretary the name of the person so
nominated and of any deputy, and shall advise the Secretary of any change within 7 days of its occurrence.
(10) If
(a) a person was issued with a wholesale poisons licence under this regulation, as in force before the
commencement date of the Pharmacy and Poisons (Amendment) Ordinance 2015 (2 of 2015)(amending
Ordinance); and
(b) that licence was in force immediately before that date,
then, for the remainder of the period for which that licence would have continued to be valid had section 46 of
the amending Ordinance not been enacted, the person is to be regarded as a licensed wholesale dealer, and the
Ordinance and regulations made under section 29 apply to the person accordingly. (2 of 2015 s. 46)
(2 of 2015 s. 46)
Regulation: 27

Sales of poisons by licensed wholesale dealers or licensed

manufacturers*

L.N. 30 of 2015

06/02/2015

A licensed wholesale dealer or licensed manufacturer must not sell or supply a poison to any person other than the
following (2 of 2015 s. 47)
(a) a licensed wholesale dealer; (2 of 2015 s. 47)
(ab) a licensed manufacturer; (2 of 2015 s. 47)
(b) an authorized seller of poisons;
(c) a registered pharmacist;
(d) a registered medical practitioner, a registered dentist or a registered veterinary surgeon; (L.N. 614 of
1997)
(e) persons who require the poison for the purpose of their trade or business;
(f) a Government department or public officer requiring the article for the purposes of the public service;
(g) a person or an establishment concerned with education or scientific research, if the article is required
for the purposes of such education or research;
(h) an institution;
(i) purchasers outside Hong Kong; or
(j) a listed seller of poisons, if the poison is included in the classes of poisons in Part II of the Poisons List that
the listed seller is licensed to sell. (2 of 2015 s. 47)
(L.N. 137 of 1978)
________________________________________________________________________________
Note:
* (2 of 2015 s. 47)

Regulation: 28
(1)

Records to be kept by licensed wholesale dealers or

licensed manufacturers*

L.N. 30 of 2015

06/02/2015

A licensed wholesale dealer or licensed manufacturer must record the following particulars for each transaction
by which any poison included in Part I of the Poisons List or any pharmaceutical product is acquired by him
whether by way of import, purchase, gift or otherwise- (2 of 2015 s. 48)

Cap 138A - PHARMACY AND POISONS REGULATIONS

11

(a) the date of the transaction;

(b) the name of the supplier;
(c) the name of the poison or pharmaceutical product;
(ca) the batch number, pack size and unit of quantity of the poison or pharmaceutical product; (2 of 2015 s. 48)
(d) the total quantity of the poison or pharmaceutical product;
(e) the nature of the transaction; and
(f) a reference to the invoice or other documents supporting the transaction.
(2) A licensed wholesale dealer or licensed manufacturer must record the following particulars for each transaction
by which any poison included in Part I of the Poisons List or any pharmaceutical product is disposed of, whether
the disposition is by way of export, sale, gift or otherwise- (2 of 2015 s. 48)
(a) the date of the transaction;
(b) the nature of the transaction;
(c) the name of the person to whom the poison or pharmaceutical product is supplied;
(d) the total quantity of the poison or pharmaceutical product;
(e) a reference to the invoice or other documents supporting the transaction;
(f) the name of the poison or pharmaceutical product;
(fa) the batch number, pack size and unit of quantity of the poison or pharmaceutical product;
(g) the balance of the poison or pharmaceutical product remaining in his possession after the transaction.
(L.N. 137 of 1978)
(3) For each poison in Part I of the Poisons List or pharmaceutical product there shall be a separate entry in the
records and all transactions involving that poison or pharmaceutical product shall be entered in a part of the records
reserved for that poison or pharmaceutical product.
(4) Unless the Committee approves another system of recording, all records of transactions must be in the
specified form.
(5) Every transaction to which these regulations relate shall be recorded within 72 hours after the time it took
place.
(6) Records of sales or supplies maintained under this regulation shall be supported by documents signed by
the purchaser.
(7) In the case of an import or export transaction, the licensed wholesale dealer or licensed manufacturer must
retain all shipping and other documents supporting the transaction. (L.N. 137 of 1978)
(8) A licensed wholesale dealer must set up and maintain a system of control that will enable the rapid and, so far as
practicable, complete recall of any lot or batch of a pharmaceutical substance or product from sale to the public
in the event of the pharmaceutical substance or product being found to be dangerous or injurious to health. (L.N.
137 of 1978)
(2 of 2015 s. 48)
________________________________________________________________________________
Note:
* (2 of 2015 s. 48)

Part:

VII

MANUFACTURE OF PHARMACEUTICAL
PRODUCTS*

L.N. 30 of 2015

06/02/2015

________________________________________________________________________________
Note:
* (2 of 2015 s. 73)

Regulation: 28A
(1)
(2)

Good Manufacturing Practice Guide

L.N. 30 of 2015

06/02/2015

The Board may issue a Good Manufacturing Practice Guide providing for the principles and guidelines of good
manufacturing practice in respect of pharmaceutical products.
The GMP Guide
(a) may consist of a code, standard, rule, specification or any other documentary form of practical guidance
prepared by the Board or any other body or authority; and
(b) may apply, incorporate or refer to a document that has been formulated or published by a body or authority
either as in force at the time when the document is so applied, incorporated or referred to or as amended,

Cap 138A - PHARMACY AND POISONS REGULATIONS

12

(3)
(4)
(5)
(6)
(7)

formulated or published from time to time.

If the GMP Guide is issued, the Board must by notice published in the Gazette
(a) identify the Guide; and
(b) specify the date on which the Guide is to take effect.
The Board may from time to time revise the whole or any part of the GMP Guide.
If the GMP Guide is revised, the Board must by notice published in the Gazette
(a) identify the Guide or part revised; and
(b) specify the date on which the revision is to take effect.
The Board must make a copy of the GMP Guide available for inspection by the public free of charge
(a) at the office of the Secretary during normal office hours; and
(b) in any other manner the Board thinks fit.
The GMP Guide, and a notice published under paragraph (3) or (5), are not subsidiary legislation.
(2 of 2015 s. 49)

Regulation: 29

Licensing of manufacturers

L.N. 30 of 2015

06/02/2015

(1) A person must not manufacture any pharmaceutical product on any premises unless he is the holder of a
licence to manufacture pharmaceutical products on those premises.
(1A) For the purposes of paragraph (1), a person is not regarded as manufacturing a pharmaceutical product only by
affixing to the container of the product a label
(a) that does not state any of the following particulars
(i) particulars mentioned in regulation 31(1)(a), (b), (e) or (f);
(ii) particulars regarding the dosage, route or frequency of administration of the product;
(iii) the name of the product; and
(b) that does not obscure, change or obliterate any of the following particulars labelled on the container
(i) particulars mentioned in subparagraph (a);
(ii) particulars mentioned in regulation 31(1)(c). (2 of 2015 s. 50)
(2) (Repealed 2 of 2015 s. 50)
(3) The Committee may, subject to any conditions it thinks fit to impose, issue a licence to manufacture
pharmaceutical products in the specified form on payment of the fee prescribed in the Ninth Schedule.
(4) In any of the circumstances specified in paragraph (4A), the Committee may
(a) revoke a licence to manufacture pharmaceutical products or suspend it for a period it thinks fit;
(b) issue a warning letter to the licensed manufacturer; or
(c) vary a condition of the licence imposed under paragraph (3). (2 of 2015 s. 50)
(4A) The circumstances are
(a) that, in the Committees opinion, the licensed manufacturer has contravened
(i) a condition of the licence or any of these regulations; or
(ii) a code of practice applicable to the licensed manufacturer or the GMP Guide; or
(b) that the licensed manufacturer has been convicted of
(i) an offence under the Ordinance or any of the regulations made under section 29, the Dangerous Drugs
Ordinance (Cap 134), the Antibiotics Ordinance (Cap 137) or the Undesirable Medical Advertisements
Ordinance (Cap 231); or
(ii) an offence under section 6C or 6D of the Import and Export Ordinance (Cap 60), section 52, 54 or 61
of the Public Health and Municipal Services Ordinance (Cap 132) or section 7, 7A or 9 of the Trade
Descriptions Ordinance (Cap 362). (2 of 2015 s. 50)
(4B) The Committee may, subject to any conditions it thinks fit to impose, suspend for a period not exceeding 3 years
(suspension period) the operation of a decision made under paragraph (4)(a) so that the decision takes effect
only if a condition so imposed is contravened during the suspension period, and in the case of such a
contravention, the decision takes effect on the date specified by the Committee having regard to all the
circumstances of the case. (2 of 2015 s. 50)
(5) For the purpose of certifying that a manufacturer is licensed under this regulation, the Committee, subject to
any conditions it may impose and to the payment of the fee prescribed in the Ninth Schedule, may issue to the
manufacturer-

Cap 138A - PHARMACY AND POISONS REGULATIONS

13

(a) a certificate for manufacture; or

(b) an interim-certificate for manufacture,
in the specified forms. (L.N. 137 of 1978)
(6) For the purpose of exporting pharmaceutical products manufactured by a licensed manufacturer, the
Committee may, subject to any conditions it may impose and to the payment of the fee prescribed in the Ninth
Schedule, issue to the manufacturer- (2 of 2015 s. 50)
(a) a free sale certificate of pharmaceutical product; or
(b) a certificate of pharmaceutical product,
in the specified forms. (L.N. 449 of 1991)
(7) Any applicant or licensed manufacturer aggrieved by a decision of the Committee under this regulation
may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980)
(L.N. 369 of 1980; 2 of 2015 s. 50)
Regulation: 30

Manufacture to be under supervision of a registered

pharmacist

L.N. 30 of 2015

06/02/2015

(1) In all premises in which pharmaceutical products are manufactured such products shall be manufactured by
or under the supervision of(a) a registered pharmacist; or (2 of 2015 s. 51)
(b) (Repealed 2 of 2015 s. 51)
(c) a person having such other qualifications or sufficient experience as may be approved by the Board.
(2) For the purposes of paragraph (1), "supervision" () means the exercise by any of the persons referred
to in paragraph (1) of control over the process of manufacture and of the persons engaged therein. (L.N. 137 of 1978)
Regulation: 30A

Authorized person to certify compliance with GMP Guide L.N. 30 of 2015

etc.

06/02/2015

(1)

A licensed manufacturer must ensure that at least one authorized person is employed to be responsible for
carrying out, in relation to the pharmaceutical products manufactured under the licence, the duties specified in
paragraph (2).
(2) An authorized person is responsible for ensuring and certifying that
(a) each batch of the pharmaceutical products has been manufactured and checked in accordance with the GMP
Guide; and
(b) the registrable particulars of each batch of the pharmaceutical products correspond exactly with the
registered particulars of the products.
(3) In this regulation
registered particulars () has the meaning given by regulation 35A;
registrable particulars () has the meaning given by regulation 35A.
(2 of 2015 s. 52)
Regulation: 30B
(1)
(2)
(3)
(4)
(5)

Register of authorized persons

L.N. 30 of 2015

06/02/2015

The Board must cause the Secretary to keep a register of authorized persons for the purposes of these
regulations.
The register may be kept in a form the Board thinks fit.
The register must contain, for each person who is registered as an authorized person under this Part
(a) the name and address of the person; and
(b) any other particulars of the person the Board thinks fit.
The Board may amend the register as to the name, address or any other particulars relating to an authorized
person whose name appears in the register on being satisfied that the amendment is necessary for preserving the
accuracy of the register.
The Secretary must make the register available for inspection by the public free of charge at the office of the
Secretary during normal office hours, and in any other manner the Secretary thinks fit, so as to enable a member

Cap 138A - PHARMACY AND POISONS REGULATIONS

14

of the public
(a) to ascertain whether a person is an authorized person; and
(b) to ascertain the particulars of the registration of the person.
(2 of 2015 s. 52)
Regulation: 30C
(1)
(2)

(3)
(4)

(2)
(3)
(4)
(5)
(6)

(4)
(5)
(6)
(7)

06/02/2015

Registration as authorized person

L.N. 30 of 2015

06/02/2015

The Committee must decide whether to grant or refuse an application for registration made under regulation
30C.
The Committee may grant an application on being satisfied that the applicant is a fit and proper person to be
registered as an authorized person.
A registration under this regulation is subject to any conditions the Committee thinks fit to impose.
On registration, the Committee must issue to the applicant a certificate of registration in the specified form on
payment of the fee prescribed in the Ninth Schedule.
Subject to regulation 30F, a registration has effect from the date on which the certificate of registration is issued
until the end of the year in which the date falls.
An applicant aggrieved by a decision made in respect of the applicant under this regulation may, in the
prescribed manner, appeal to the Tribunal against that decision.
(2 of 2015 s. 52)

Regulation: 30E
(1)
(2)
(3)

L.N. 30 of 2015

A person who satisfies the requirements specified in paragraph (2) may apply to the Committee for registration
as an authorized person.
The requirements are that
(a) the person
(i) is a registered pharmacist; or
(ii) holds a qualification awarded on completion of a course recognized by the Committee; and
(b) the person
(i) has at least 3 years relevant experience in Hong Kong or a place outside Hong Kong in
manufacturing pharmaceutical products in accordance with the GMP Guide or a document similar or
equivalent to that Guide issued or adopted by a competent authority of a place outside Hong Kong; or
(ii) meets any other criteria that the Committee may specify.
The application must be in the specified form.
The Committee may require the applicant to provide any information or document that the Committee considers
reasonably necessary for determining the application.
(2 of 2015 s. 52)

Regulation: 30D
(1)

Application for registration as authorized person

Renewal of registration of authorized person

L.N. 30 of 2015

06/02/2015

The Committee may, on an application, renew the registration of an authorized person.

An application for renewal of registration must be in the specified form.
The Committee may require the applicant to provide any information or document that the Committee considers
reasonably necessary for determining the application.
A registration renewed under this regulation is subject to any conditions the Committee thinks fit to impose.
On renewal of registration, the Committee must issue to the applicant a renewed certificate of registration in the
specified form on payment of the fee prescribed in the Ninth Schedule.
Subject to regulation 30F, a renewed registration has effect from the date on which the renewed certificate of
registration is issued until the end of the year in which the date falls.
An applicant aggrieved by a decision made in respect of the applicant under this regulation may, in the
prescribed manner, appeal to the Tribunal against that decision.
(2 of 2015 s. 52)

Cap 138A - PHARMACY AND POISONS REGULATIONS

15

Regulation: 30F
(1)

(2)

(3)

(4)

(5)
(6)

Cancellation or suspension etc. of registration as

authorized person

L.N. 30 of 2015

06/02/2015

The Committee may exercise any one or more of the following powers in any of the circumstances specified in
paragraph (2) in respect of a person registered as an authorized person under this Part
(a) cancel the registration;
(b) suspend the registration for a period specified by the Committee;
(c) issue a warning letter to the person;
(d) vary a condition of the registration imposed under regulation 30D(3) or 30E(4).
The circumstances are
(a) that the Committee is satisfied that the person is no longer a fit and proper person to be registered as an
authorized person;
(b) that in the Committees opinion, the person has contravened
(i) a condition of the registration; or
(ii) any of these regulations or a code of practice applicable to the person as an authorized person; or
(c) that the person has been convicted of
(i) an offence under the Ordinance or any of the regulations made under section 29, the Dangerous Drugs
Ordinance (Cap 134), the Antibiotics Ordinance (Cap 137) or the Undesirable Medical Advertisements
Ordinance (Cap 231); or
(ii) an offence under section 52, 54 or 61 of the Public Health and Municipal Services Ordinance (Cap
132) or section 7, 7A or 9 of the Trade Descriptions Ordinance (Cap 362).
The Committee may, subject to any conditions it thinks fit to impose, suspend for a period not exceeding 3 years
(suspension period) the operation of a decision made under paragraph (1)(a) or (b) so that the decision takes
effect only if a condition so imposed is contravened during the suspension period, and in the case of such a
contravention, the decision takes effect on the date specified by the Committee having regard to all the
circumstances of the case.
The Committee must cause the Secretary to
(a) as soon as practicable after cancelling a persons registration under paragraph (1)(a), remove the entries
relating to the person from the register of authorized persons; or
(b) as soon as practicable after suspending a persons registration under paragraph (1)(b), remove the entries
relating to the person from the register of authorized persons, and restore those entries to the register as
soon as practicable after the period of suspension expires.
A person whose registration as an authorized person is cancelled must immediately return to the Committee the
certificate of registration or renewed certificate of registration issued to the person under regulation 30D or 30E.
A person mentioned in paragraph (1) who is aggrieved by a decision made in respect of the person under this
regulation may, in the prescribed manner, appeal to the Tribunal against that decision.
(2 of 2015 s. 52)

Regulation: 31

Labelling by licensed manufacturers*

L.N. 30 of 2015

06/02/2015

(1) Subject to paragraph (4), a licensed manufacturer shall label or cause to be labelled the container of each
pharmaceutical product, with the following particulars- (2 of 2015 s. 53)
(a) the appropriate designation of(i) the substance or substances from which the pharmaceutical product was manufactured;
(ii) each of the active constituents of the product; or
(iii) each of the ingredients from which the product was compounded;
(b) in the case where the appropriate designation of each of the active constituents or ingredients of a
product is given, the appropriate quantitative particulars of those constituents or ingredients;
(c) the name and address of the manufacturer; (2 of 2015 s. 53)
(d) the number of the certificate of drug/product registration or the provisional certificate of drug/product
registration of the pharmaceutical product issued by the Board; (2 of 2015 s. 53)
(e) the batch number of the pharmaceutical product; and (2 of 2015 s. 53)
(f) the expiry date of the pharmaceutical product. (2 of 2015 s. 53)
(2) For the purposes of paragraph (1)-

Cap 138A - PHARMACY AND POISONS REGULATIONS

16

(a) the expression "appropriate designation" ( ), in relation to a substance, constituent or

ingredient, means(i) in the case of a poison included in the Poisons List, the name with which the container of the
poison is for the time being required to be labelled in accordance with regulation 13;
(ii) in the case where a substance, constituent or ingredient is not a poison and is described in any of
the monographs contained in the edition of the British pharmacopoeia, the British
Pharmaceutical Codex or the British Veterinary Codex which was last published before the date
on which the article was sold or supplied, the description set out at the head of that monograph;
and
(iii) in any other case the accepted scientific name or the name descriptive of the true nature and
origin of the substance, constituent or ingredient;
(b) the expression "appropriate quantitative particulars" ( ), in relation to the active
constituent or ingredient of a pharmaceutical product, means(i) the percentage or quantity of that constituent or ingredient contained in the pharmaceutical
product sold or supplied; or
(ii) in the case of a pharmaceutical product which is in pill, capsule, tablet or similar article, either
the percentage or quantity of the substance or substances comprising or forming part of the pills,
capsules, tablets or similar articles, or the quantity of each constituent or ingredient in each pill,
capsule, tablet or article; (2 of 2015 s. 53)
(c) batch number ( ), in relation to a pharmaceutical product, means a unique combination of
numbers, letters or other symbols from which
(i) the batch or lot to which the product belongs can be identified; and
(ii) the production and distribution history of the product can be determined; (2 of 2015 s. 53)
(d) expiry date (), in relation to a pharmaceutical product, means the date determined, on the basis of
the products specifications registered under regulation 36(3)(a)(ii), by the manufacturer as the date after
which the product should not be used, assuming that the product is stored under conditions suitable to the
product. (2 of 2015 s. 53)
(3) For the purposes of paragraph (1) the container to be labelled shall, where the pharmaceutical product is
packed by the manufacturer in more than one container, be the container which is likely to be sold or distributed to the
ultimate user of the product.
(4) In the case of a pharmaceutical product intended for export it shall be a sufficient compliance with this
regulation if the container of the product is labelled with the following particulars(a) the name and address of the manufacturer; and
(b) such other details as the importing country may require. (L.N. 137 of 1978)
________________________________________________________________________________
Note:
* (2 of 2015 s. 53)

Regulation: 32

Manufacturing workers not to infect products

L.N. 30 of 2015

06/02/2015

A licensed manufacturer must take adequate steps to ensure that every person engaged in the manufacturing of
pharmaceutical products does not contaminate or infect such products.
(2 of 2015 s. 54)
Regulation: 33

Duties of licensed manufacturers regarding identity,

purity, safety, etc.*

L.N. 30 of 2015

06/02/2015

(1) Subject to paragraph (1A), a licensed manufacturer must test each lot or batch of raw or bulk material
intended to be used in the manufacture of pharmaceutical products to ensure identity and purity.
(1A) Raw or bulk material the identity and purity of which the manufacturer thereof has certified by a certificate
of analysis does not require a test by a licensed manufacturer under paragraph (1).
(2) A licensed manufacturer must ensure that the registrable particulars of each batch of pharmaceutical products in
a finished form correspond exactly with the registered particulars of the products. (2 of 2015 s. 55)
(3) Every parenteral product shall be manufactured in accordance with the method of preparation of injections

Cap 138A - PHARMACY AND POISONS REGULATIONS

17

laid down by the British Pharmacopoeia or other Pharmacopoeia with which the particular product is intended to
comply.
(4) Unless paragraph (4B) applies, a licensed manufacturer must retain a control sample of each batch of
finished products under conditions of storage suitable to that product for a period of not less than 1 year after the
expiry date of the product.
(4A) Paragraph (4B) applies to a licensed manufacturer in respect of a batch of pharmaceutical products if all of the
following conditions are satisfied
(a) the products are enclosed in a primary container in which the products are to be sold or supplied;
(b) the process of manufacture that the manufacturer carries out, in respect of the products, only involves one or
more of the following
(i) adding a package insert;
(ii) replacing a package insert;
(iii) (if the products are intended for export) affixing a label to any labelled container of the products, and
the label does not obscure, change or obliterate any of the following particulars appearing on that
labelled container
(A) particulars required to be labelled under regulation 31(4);
(B) the name of the products;
(C) the batch number of the products;
(D) the expiry date of the products;
(iv) (if the products are not intended for export) affixing a label to any labelled container of the products,
and the label does not obscure, change or obliterate any of the following particulars appearing on that
labelled container
(A) the registered particulars of the products;
(B) the batch number of the products;
(C) the expiry date of the products;
(c) throughout the process of manufacture, the primary container remains closed. (2 of 2015 s. 55)
(4B) The manufacturer is only required to retain a sample of the following of the batch of finished products for a
period of not less than 1 year after the expiry date of the products
(a) if paragraph (4A)(b)(i) applies, the package insert added;
(b) if paragraph (4A)(b)(ii) applies, the replacing package insert;
(c) if paragraph (4A)(b)(iii) or (iv) applies, the label affixed. (2 of 2015 s. 55)
(5) A licensed manufacturer must set up and maintain a system of control that will enable the rapid and, so far
as practicable, complete recall of any lot or batch of a pharmaceutical substance or product from sale to the public in
the event of the pharmaceutical substance or product being found to be dangerous or injurious to health.
(6) Despite paragraphs (4) and (4B)(c), a licensed manufacturer is not required to comply with paragraph (4) or
(4B)(c) (as applicable) in respect of a batch of pharmaceutical products if the manufacturer is not regarded as
manufacturing the products for the purposes of regulation 29(1). (2 of 2015 s. 55)
(7) In this regulation
batch number () has the meaning given by regulation 31(2)(c);
expiry date () has the meaning given by regulation 31(2)(d);
labelled container (), for a pharmaceutical product, means a container of the product on which the
following particulars appear
(a) the name of the product;
(b) the batch number of the product;
(c) the expiry date of the product;
package insert () has the meaning given by regulation 36(3A);
primary container (), for a pharmaceutical product, means the container that is in direct contact with the
product;
registered particulars () has the meaning given by regulation 35A;
registrable particulars () has the meaning given by regulation 35A.
(L.N. 137 of 1978; 2 of 2015 s. 55)
________________________________________________________________________________

Cap 138A - PHARMACY AND POISONS REGULATIONS

18

Note:
* (2 of 2015 s. 55)

Regulation: 34

Licensed manufacturers premises*

L.N. 30 of 2015

06/02/2015

(1) No pharmaceutical product shall be manufactured unless the premises and the fittings and machinery
therein used in the manufacturing of such product are of such construction, materials and finish as to- (2 of 2015 s.
56)
(a) permit the ready and efficient cleaning of all surfaces; and
(b) avoid the contamination of the product during manufacture. (2 of 2015 s. 56)
(2) All premises used in the manufacturing, testing and despatch of pharmaceutical products shall be- (2 of
2015 s. 56)
(a) suitable for the purpose; and
(b) maintained in a clean and orderly condition.
(3) The temperature and humidity of the premises shall be controlled as appropriate to the manufacture of the
product or the process being carried out therein.
(4) All parenteral products shall be manufactured and put into containers in an enclosed area in which aseptic
conditions can be maintained.
(5) The enclosed area referred to in paragraph (4) shall be separate from the areas used for the manufacture of
other pharmaceutical products. (2 of 2015 s. 56)
________________________________________________________________________________
Note:
* (2 of 2015 s. 56)

Regulation: 35

Records to be kept by licensed manufacturers*

L.N. 30 of 2015

06/02/2015

(1) A licensed manufacturer must maintain adequate records in respect of each pharmaceutical product
prepared by him, showing- (2 of 2015 s. 57)
(a) the quantities of all substances used in the manufacture of the product;
(b) the quantity of the product manufactured;
(c) the name and the address of the person to whom the pharmaceutical product was sold or supplied;
(d) the nature and results of tests made on each lot or batch of raw or bulk materials used in the product;
(e) the nature and results of tests made on each batch of finished product;
(f) any complaints received relating to the product and the action taken thereon by him; and
(g) the nature and result of any tests made on the samples retained. (L.N. 228 of 1975)
(2) A record showing the matters mentioned in paragraph (1)(a), (b), (d), (e) or (g) must be completed when the
manufacturing process or test concerned is being carried out. (2 of 2015 s. 57)
(3) A record showing the matters mentioned in paragraph (1)(c) must be completed within 72 hours after the
transaction concerned takes place. (2 of 2015 s. 57)
(4) For the purposes of paragraph (1)(f)
(a) a record showing a complaint must be completed within 72 hours after the complaint is received by the
licensed manufacturer; and
(b) a record showing an action taken in respect of a complaint must be completed within 72 hours after the
action is taken. (2 of 2015 s. 57)
________________________________________________________________________________
Note:
* (2 of 2015 s. 57)

Part:

VIII

Regulation: 35A

REGISTRATION OF PHARMACEUTICAL PRODUCTS

AND SUBSTANCES

30/06/1997

Interpretation (Part VIII)

30/06/1997

In this Part, unless the context otherwise requires-

Cap 138A - PHARMACY AND POISONS REGULATIONS

19

"additional particulars" ( ), in relation to a pharmaceutical product or substance registered before the

commencement date, means those registrable particulars of the product or substance not referred to in the
repealed regulation 36(3);
"commencement date" ( ) means the commencement date* of section 4 of the Pharmacy and Poisons
(Amendment) (No. 2) Regulation 1995 (L.N. 366 of 1995);
"registered particulars" () means(a) in relation to a pharmaceutical product or substance registered before the commencement date(i) such of its particulars as are registered under the repealed regulation 36(3); and
(ii) its additional particulars as contained in or ascertainable from the application form, the relevant
literature and supporting documents (if any) submitted to the Committee for the purpose of the
registration of the product or substance, or as contained in or ascertainable from the specimen
sales packs or samples (or prototypes of the packs and proposed wordings of the labels) made
available for inspection by the Committee for the purpose of the registration of the product or
substance;
(b) in relation to a pharmaceutical product or substance registered on or after the commencement date, its
registrable particulars as registered under regulation 36(3), or
in either case, where from time to time any subsequent approval has been given by the Board or the Committee
to change any of the registrable particulars of the product or substance as from a certain date, then as from that
date, its said particulars changed in accordance with such approval;
"registered product or substance" () means any pharmaceutical product or substance which is the
subject of a valid registration certificate issued under regulation 36(5);
"registrable particulars" (), in relation to a pharmaceutical substance, means the particulars referred to in
regulation 36(3)(a), and, in relation to a pharmaceutical product, means all of the particulars referred to in
regulation 36(3)(a) and (b);
"repealed regulation 36(3)" (36(3)) means the regulation 36(3) which was in force immediately before
the commencement date.
(L.N. 366 of 1995)
________________________________________________________________________________
Note:
* Section 4 of L.N. 366 of 1995 commenced operation on 28 July 1995.

Regulation: 36

Registration of pharmaceutical products and substances

L.N. 30 of 2015

06/02/2015

(1) Subject to paragraphs (1A), (1B) and (1C), no person shall sell, offer for sale or distribute or possess for the
purposes of sale, distribution or other use any pharmaceutical product or substance unless the product or substance is
registered with the Board- (L.N. 85 of 1987; L.N. 366 of 1995)
(a) by the licensed manufacturer, or a licensed wholesale dealer who has entered into a contract with the
licensed manufacturer under which the licensed manufacturer is required to manufacture the
pharmaceutical product or substance, if the pharmaceutical product or substance is manufactured in
Hong Kong;
(b) by a person referred to in section 28A(1) or (3) who imports the pharmaceutical product or substance
into Hong Kong, if the pharmaceutical product or substance is manufactured outside Hong Kong; or
(c) by the local branch, subsidiary, representative, agent or distributor of a manufacturer outside Hong
Kong. (L.N. 137 of 1978; 23 of 1998 s. 2; 2 of 2015 s. 58)
(1A) Nothing in paragraph (1) shall apply in the case of possession or use where the pharmaceutical product or
substance(a) has been imported into Hong Kong(i) to be exported outside Hong Kong; or (2 of 2015 s. 58)
(ii) by a licensed manufacturer for the purpose of manufacture or the compounding of pharmaceutical
preparations; (2 of 2015 s. 58)
(iii) (Repealed 2 of 2015 s. 58)
(ab) is possessed or is to be used for the purpose of treatment by a registered medical practitioner or a registered
dentist of a particular patient or for the purpose of treatment by a registered veterinary surgeon of a
particular animal; (2 of 2015 s. 58)

Cap 138A - PHARMACY AND POISONS REGULATIONS

20

(b) has been manufactured in Hong Kong to be exported outside Hong Kong; (L.N. 85 of 1987; 2 of 2015
s. 58)
(c) is to be administered for the purposes of a clinical trial that is to be conducted in accordance with a clinical
trial certificate issued under regulation 36B(3); or (2 of 2015 s. 58)
(d) is to be administered for the purposes of a medicinal test that is to be conducted in accordance with a
medicinal test certificate issued under regulation 36B(3). (2 of 2015 s. 58)
(1B) For the avoidance of any doubt, a pharmaceutical product or substance is registered with the Board, for the
purposes of paragraph (1), if and only if its registrable particulars are those which correspond exactly with the
registered particulars of a registered product or substance. (L.N. 366 of 1995)
(1C) It shall be a defence to a charge against any person for contravening paragraph (1) if the person proves that
he did not know and could not with reasonable diligence have discovered that the product or substance was not
registered with the Board. (L.N. 366 of 1995)
(2) Application for the initial registration of a pharmaceutical product or substance shall be made in the
specified form and shall be accompanied by the fee prescribed in the Ninth Schedule. (2 of 2015 s. 58)
(2A) In considering an application for registration of a pharmaceutical product which contains as active
ingredients any Chinese herbal medicines or proprietary Chinese medicines as defined in section 2 of the Chinese
Medicine Ordinance (Cap 549) or other materials of herbal, animal or mineral origin customarily used by the Chinese
for medicinal purpose, the Board shall seek advice from the Chinese Medicines Board established under the Chinese
Medicine Ordinance (Cap 549). (47 of 1999 s. 175)
(3) The particulars to be registered shall(a) in the case of a product or substance, be(i) its name;
(ii) its specifications;
(iii) its label;
(iv) its package insert, if any;
(v) the name and address of the manufacturer; and
(vi) the name and address of the applicant;
(b) in the case of a product, further be(i) its dose form;
(ii) the quantity or quantities of the dose form contained in its unit package or unit packages;
(iii) the name and quantity of all its active ingredients;
(iv) the name and quantity of all its excipients; and
(v) its proposed indication, dosage and route of administration. (L.N. 366 of 1995)
(3A) For the purposes of paragraph (3)"active ingredient" () means an ingredient of the product which is not an excipient;
"excipient" () means an ingredient of the product which does not contribute to its pharmacological action or
which so contributes only by regulating the release of an active ingredient;
"label" () means any statement forming part of or affixed to the container or package of the product or substance;
"package insert" () means any leaflet, notification or other document supplied with the container or package
of the product or substance, but does not include a label. (L.N. 366 of 1995)
(4) Representative specimen sales packs of the product or representative samples of the substance shall be
made available for inspection by the Committee. In the case of products not yet marketed the Committee may accept
prototypes of the packs and proposed wordings of the labels on the understanding that these will be replaced by actual
sale packs not later than 6 months after registration of the product or substance.
(5) The Committee may, subject to any conditions it thinks fit to impose, register a pharmaceutical product or
substance by issuing to the applicant a registration certificate in the specified form and the certificate is valid for a
period of 5 years from the date of registration on payment of the fee prescribed in the Ninth Schedule. (2 of 2015 s.
58)
(6) The Committee shall advise the applicant whether the pharmaceutical product or substance appears in the
Poisons List and if so, under which classification.
(7) A registration certificate issued under paragraph (5) shall be renewable on (2 of 2015 s. 58)
(a) payment of the fee prescribed in the Ninth Schedule; and
(b) providing the Committee with the up-to-date information specified by the Committee regarding the
pharmaceutical product or substance. (2 of 2015 s. 58)

Cap 138A - PHARMACY AND POISONS REGULATIONS

21

(7A) A renewal under paragraph (7) is subject to any conditions the Committee thinks fit to impose. (2 of 2015 s. 58)
(7B) The Committee may vary a condition imposed under paragraph (5) or (7A) if it thinks fit to do so. (2 of 2015 s.
58)
(8) The Committee may deregister a pharmaceutical product or substance, suspend the registration of a
pharmaceutical product or substance for a period specified by the Committee, or issue a warning letter to the holder of
a registration certificate, if it is of the opinion that a condition of the registration is contravened or if it considers it to
be in the public interest to do so. (2 of 2015 s. 58)
(8A) Where the Committee refuses to register or deregisters a pharmaceutical product or substance it shall
forward to the applicant or permit holder, as the case may be, a notice of refusal or of deregistration and shall state in
such notice its reasons for refusal to register or for deregistration. (L.N. 137 of 1978)
(9) Any applicant or holder of a registration certificate aggrieved by a decision of the Committee under this
regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N. 369 of 1980; 2 of 2015 s.
58)
(10) (Repealed L.N. 369 of 1980)
(11) (Repealed L.N. 366 of 1995)
(L.N. 137 of 1978; L.N. 369 of 1980)
Regulation: 36A

Application for approval to change the registered

particulars of a registered product or substance

30/06/1997

(1) In this regulation"person responsible for registering a registered product or substance" () means a
person who, in relation to the product or substance, belongs to any one of the classes of person described in
regulation 36(1)(a), (b) or (c).
(2) The person responsible for registering a registered product or substance may apply in writing to the
Committee for approval to change any of the registrable particulars of the product or substance except the particulars
referred to in regulation 36(3)(a)(i) and (b)(i) and (iii).
(3) A person responsible for registering a registered product or substance who proposes to change the
particulars referred to in regulation 36(3)(a)(i) or (b)(i) or (iii) may apply under regulation 36 for registering, as a
separate product or substance, as the case may be, the product or substance with the particulars changed as proposed.
(4) In dealing with an application under paragraph (2)(a) the Committee shall take into consideration the safety, efficacy and quality of the pharmaceutical
product or substance with its particulars changed as proposed, and in considering such safety and
efficacy, the Committee shall observe the requirements of regulation 37(2); and
(b) regulation 37(3) shall apply to such application as if it were an application for initial registration of the
pharmaceutical product or substance with the particulars changed as proposed.
(5) The Committee shall advise the applicant in writing whether the change is approved, and where the
Committee refuses to approve a change it shall state its reasons for such refusal.
(6) Where the change is approved, it shall be approved to take effect from a certain date, and the following
provisions shall apply(a) as from that date, and without limiting the generality of regulation 36(1B), the product or substance
having as its registrable particulars the registered particulars which are to be changed (hereinafter
referred to as the "product or substance to be replaced") shall not be regarded as registered with the
Board;
(b) the applicant shall, prior to that date, recall or cause to be recalled any product or substance to be
replaced which may still be in the possession of any person to whom he supplied the product or
substance;
(c) where the product or substance to be replaced is to be recalled, the applicant shall, as soon as
reasonably possible, replace or cause to be replaced such product or substance with the product or
substance having the particulars changed as approved, or make such alternative arrangements as are
agreed with the person to whom he supplied the product or substance.
(7) Any person aggrieved by a decision of the Committee under this regulation may, in the prescribed manner,
appeal to the Tribunal against that decision.
(L.N. 366 of 1995)

Cap 138A - PHARMACY AND POISONS REGULATIONS

22

Regulation: 36B

Clinical trials and medicinal tests

L.N. 30 of 2015

06/02/2015

(1)

A person must not conduct a clinical trial on human beings, or cause or permit such a trial to be conducted,
except in accordance with a clinical trial certificate issued to the person under paragraph (3). (2 of 2015 s. 59)
(1A) A person must not conduct a medicinal test on animals, or cause or permit such a test to be conducted, except in
accordance with a medicinal test certificate issued to the person under paragraph (3). (2 of 2015 s. 59)
(1B) A person who contravenes paragraph (1) or (1A) commits an offence and is liable to a fine at level 2. (2 of 2015
s. 59)
(1C) For the purpose of conducting a clinical trial on human beings or a medicinal test on animals application
shall be made in writing to the Committee and shall be accompanied by the fee prescribed in the Ninth Schedule.
(2) A copy of the protocol for the trial or test shall accompany the application.
(3) The Committee may, subject to any conditions it thinks fit to impose, issue a clinical trial certificate or
medicinal test certificate in the specified form and the certificate is valid for a period not exceeding 5 years on
payments of the fee prescribed in the Ninth Schedule.
(3A) The Committee may vary a condition imposed under paragraph (3) if it thinks fit to do so. (2 of 2015 s. 59)
(3B) The Committee may cancel a clinical trial certificate or medicinal test certificate, suspend it for a period
specified by the Committee, or issue a warning letter to the holder of the certificate, if
(a) it is of the opinion that the holder of the certificate has contravened a condition of the certificate; or
(b) it considers it to be in the public interest to do so. (2 of 2015 s. 59)
(3C) If the Committee refuses an application under paragraph (1C), the Committee must give the applicant a notice of
refusal and state in the notice the reasons for refusal. (2 of 2015 s. 59)
(3D) If the Committee decides to cancel or suspend a certificate under paragraph (3B), the Committee must give the
holder of the certificate a notice of cancellation or suspension (as the case may be) and state in the notice the
reasons for its decision. (2 of 2015 s. 59)
(4) Any applicant or holder of a clinical trial certificate or medicinal test certificate aggrieved by a decision of
the Committee under this regulation may, in the prescribed manner, appeal to the Tribunal against that decision. (L.N.
369 of 1980)
(L.N. 137 of 1978; L.N. 360 of 1980; 2 of 2015 s. 59)
Regulation: 36C

30/06/1997

Definition of "pharmaceutical product" and "substance"

for the purposes of this Part

For the purposes of this Part "pharmaceutical product" () and "substance" () have the meaning
assigned to "pharmaceutical product" and "medicine" in the Ordinance.
(L.N. 137 of 1978)
Regulation: 36D

30/06/1997

Duplicate certificates

(1) The Committee may issue a duplicate of any certificate issued under this Part if the Committee is satisfied
that the original certificate has been lost or destroyed or that for other good reason such duplicate ought to be issued.
(2) A duplicate certificate issued under this regulation shall be certified in such manner as the Committee may
determine.
(3) There shall be payable in respect of any duplicate certificate issued under this regulation the fee prescribed
in respect thereof in the Ninth Schedule.
(L.N. 369 of 1980)
Regulation: 37

Factors relevant to determination of application for

registration

L.N. 30 of 2015

06/02/2015

(1) In dealing with an application for initial registration of a pharmaceutical product or substance the
Committee shall in particular take into consideration(a) the safety of the pharmaceutical product or substance to which the application relates;
(b) the efficacy of the pharmaceutical product or substance for the purposes for which the product or
substance is proposed to be administered; and

Cap 138A - PHARMACY AND POISONS REGULATIONS

23

(c) the quality of the pharmaceutical product or substance according to the specification and the method or
proposed method of manufacture of the product or substance, and the provisions proposed for securing
that the product or substance as sold or supplied will be of that quality.
(2) In taking into consideration the efficacy for a particular purpose of a pharmaceutical product or substance to
which such an application relates, the Committee shall leave out of account any question whether a pharmaceutical
product or substance of another description would or might be equally or more efficacious for that purpose:
Provided that nothing in the paragraph shall be construed as requiring the Committee, in considering the safety
of a pharmaceutical product or substance of a particular description, in relation to a purpose for which it is proposed to
be administered, to leave out of account any question whether a pharmaceutical product or substance of another
description, being equally or more efficacious for that purpose, would or might be safer in relation to that purpose.
(3) In dealing with an application made in respect of a pharmaceutical product or substance manufactured
outside Hong Kong, the Committee shall also take into consideration in particular the methods, standards and
conditions of manufacture of the pharmaceutical product or substance in respect of which application is made and
may, if it thinks fit, require the applicant to take any or all of the following actions- (2 of 2015 s. 60)
(a) produce an undertaking, given by the manufacturer of any such products or substances, to permit the
premises where they are to be manufactured, and the operations carried on or to be carried on in the
course of manufacturing them, to be inspected by or on behalf of the Committee; (2 of 2015 s. 60)
(b) produce a declaration, given by or on behalf of the manufacturer of any such products or substances,
that, in relation to the manufacture of these products any requirements imposed by or under the law of
the country in which they are or are to be manufactured have been or will be complied with; (2 of
2015 s. 60)
(c) pay a fee determined by the Committee as representing the expenditure incurred, or likely to be incurred, by
or on behalf of the Committee in carrying out an inspection mentioned in subparagraph (a). (2 of 2015 s.
60)
(4) The Committee shall make arrangements for the separate processing of an application for the registration of
a new pharmaceutical product or new substance so that its registration shall not be unduly delayed. (L.N. 137 of
1978)
(5) For the purposes of paragraph (4) "new pharmaceutical product" () and "new substance" (
) mean a medicine containing an active ingredient, or a substance, having a chemical formula which has not
previously been marketed or registered in Hong Kong under some other name or description. (L.N. 137 of 1978; L.N.
235 of 1996)
(L.N. 369 of 1980)
Part:

VIIIA

(Repealed 2 of 2015 s. 61)

L.N. 30 of 2015

06/02/2015

Regulation: 37A

(Repealed 2 of 2015 s. 61)

L.N. 30 of 2015

06/02/2015

Part:

SALE OF MEDICINES

30/06/1997

Disclosure of composition of medicines

30/06/1997

IX

Regulation: 38

(1) Subject to these regulations, no person shall(a) sell any article consisting of or comprising a substance recommended as a medicine; or
(b) supply any such article as a sample for the purpose of inducing persons to buy the substances of which
it consists or which it comprises,
unless(i) the article is labelled as required under regulation 31; or
(ii) the particulars specified under regulation 31(1) are printed so as to be clearly legible in English or
Chinese on the article or a label affixed thereto. (L.N. 137 of 1978)
(2) Nothing in this regulation shall apply to any article(a) made up and supplied for the use of a particular person, being an article prescribed by reference to the

Cap 138A - PHARMACY AND POISONS REGULATIONS

24

needs of that person; or

(b) consisting wholly of either(i) a product resulting solely from the pharmaceutical treatment of natural products as referred to by
the Chinese Herbal Materia Medica;
(ii) a mixture the sole ingredients of which are two or more of such products; or
(iii) a natural mineral water or an artificial imitation thereof.
(3) For the purposes of this regulation"advertisement" ( ) includes any notice, circular, pamphlet, label, wrapper or other document, and any
announcement made orally or by any means of producing or transmitting light or sound;
"proprietary designation" (), in relation to the sale of an article consisting of or comprising a substance
recommended as a medicine, means words used or proposed to be used in connection with the sale of articles
consisting of or comprising the substance, for the purpose of indicating that they are the goods of a particular
person by virtue of manufacture, selection, certification, dealing with or offering for sale; and "proprietor" (
) in relation to such a designation means the person whose goods are indicated or intended to be indicated by
the designation;
"substance" () includes a preparation;
"substance recommended as a medicine" (), in relation to the sale of an article consisting or
comprising a substance so recommended, means a substance which is referred to(a) on the article, or on any wrapper or container in which the article is sold, or on any label affixed to, or
in any document enclosed in, the article or such wrapper or container; or
(b) in any placard or other document exhibited at the place where the article is sold; or
(c) in any advertisement published after the coming into operation of these regulations by or on behalf of
the manufacturer of the article, or the person carrying on the business in the course of which the article
was sold, or, in a case where the article was under a proprietary designation, the proprietor of the
designation,
in terms which are calculated to lead to the use of the substance for the prevention or treatment of any ailment,
infirmity or injury affecting the human body, not being terms which give a definite indication that the substance is
intended to be used as, or as part of, a food or drink, and not as, or as part of, a medicine.
Regulation: 38A

30/06/1997

Labelling of certain medicines

(1) No person shall sell or supply any medicine unless it is labelled with particulars printed so as to be clearly
legible in English and Chinese, as to dosage and the route and frequency of administration.
(2) This regulation shall not apply to medicine that is included in Part I of the Poisons List or in the Schedule to
the Antibiotics Regulations (Cap 137 sub. leg. A).
(L.N. 85 of 1987)
Part:

Regulation: 38B
(1)
(2)

30/06/1997

MISCELLANEOUS
Power to specify forms

L.N. 30 of 2015

06/02/2015

An executive committee established under section 4A for a provision of these regulations may specify forms to
be used for that provision.
If a form is specified under this regulation, the Board must make copies of the form available for inspection by
the public free of charge
(a) at the office of the Secretary during normal office hours; and
(b) in any other manner the Board thinks fit.
(2 of 2015 s. 62)

Regulation: 39

Period of keeping of records

L.N. 30 of 2015

06/02/2015

All-

Cap 138A - PHARMACY AND POISONS REGULATIONS

25

(a)
(b)
(c)
(d)

poisons books;
books kept under section 28(3);
certificates given; under section 22(1)(a) kept by authorized sellers of poisons;
books or other form of records and documents required to be kept or retained by licensed wholesale
dealers or licensed manufacturers under regulation 28; and (2 of 2015 s. 63)
(e) all records and documents required to be kept or retained by licensed manufacturers under regulation
35, (2 of 2015 s. 63)
shall be preserved by the authorized seller of poisons, licensed wholesale dealer or licensed manufacturer, as the case
may be, in the premises in which the transaction recorded took place- (2 of 2015 s. 63)
(i) for a period of 2 years from the date of the last entry therein; or
(ii) in relation to a certificate or document, for a period of 2 years from the date of the transaction.
Regulation: 40

L.N. 30 of 2015

Penalties

06/02/2015

Any person who contravenes any of the provisions of regulation 9(1) or (4), 10, 10A, 11, 12, 15, 16(1) or (2), 18,
19, 20, 21(1) or (2), 22(2), (3), (4) or (5), 23(1), (2) or (3), 24, 25, 27, 28, 29(1), 30(1), 31(1), 32, 33(1), (2), (3), (4),
(4B) or (5), 34, 35, 36(1), 36A(6)(b), 38(1), 38A or 39 commits an offence and is liable on conviction to the penalties
specified in section 34 of the Ordinance.
(L.N. 262 of 1995; L.N. 366 of 1995; 2 of 2015 s. 64)
Regulation: 41

Certificates, forms and fees

L.N. 30 of 2015

06/02/2015

(1) The certificate referred to in section 22(1)(a) may be given by any person known both to the intending
purchaser and the intending seller and shall be in the specified form. (2 of 2015 s. 65)
(2) (Repealed 2 of 2015 s. 65)
(2A) The logo referred to in section 13A(1) shall be in the form prescribed in the Eighth Schedule. (See Eighth
Schedule, Form 17) (L.N. 85 of 1987)
(3) (Repealed 2 of 2015 s. 65)
(4) The fees to be paid under the Ordinance and these regulations shall be those prescribed in the Ninth
Schedule.
Regulation: 42

(Omitted as spent)

Schedule:

SUBSTANCES TO WHICH CERTAIN RESTRICTIONS L.N. 193 of 2015 09/10/2015

WITH RESPECT TO THE SALE, SUPPLY,
LABELLING AND STORAGE APPLY UNDER
REGULATIONS 3, 5, 6, 22 AND 24*

30/06/1997

[regulations 3, 5, 6, 7,17, 22
& 24 & 5th Schedule]
(2 of 2015 s. 66)
SUBSTANCES TO WHICH CERTAIN RESTRICTIONS WITH
RESPECT TO THE SALE, SUPPLY, LABELLING AND
STORAGE APPLY UNDER REGULATIONS
3, 5, 6, 22 AND 24
(L.N. 41 of 2007; 2 of 2015 s.66)
DIVISION A
Abacavir; its salts
Abatacept
Abciximab

Cap 138A - PHARMACY AND POISONS REGULATIONS

26

Abiraterone; its salts

Acamprosate; its salts
Acarbose; its salts
Acebutolol; its salts
Acemetacin; its salts
Acetanilide; alkyl acetanilides
Acetazolamide; its salts
Acetohexamide
Acetorphine; its salts; its esters and ethers; their salts
Acetylcarbromal
Acetyldihydrocodeine; its salts
Aciclovir; its salts; except when contained in skin creams packed in a package size of not more than 3 grams and
labelled for the treatment of cold sores only
Acipimox; its salts
Acitretin; its salts; its esters
Adalimumab
Adapalene; its salts; its esters
Adefovir; its salts; its esters; their salts
Afatinib; its salts
Aflibercept
Agalsidase beta
Agomelatine; its salts
Alclofenac; its complexes
Alcuronium; its salts
Aldesleukin
Alefacept
Alemtuzumab
Alendronic acid; its salts
Alfuzosin; its salts
Alglucosidase alfa
Aliskiren; its salts; its esters; their salts
Alizapride; its salts
Alkaloids, the following; their quaternary compounds; any salts, simple or complex, of any substance falling within
the followingCalabar bean, alkaloids of
Coca, alkaloids of, except substances containing less than 0.1% of the alkaloids of coca
Cocaine, except substances containing less than 0.1% of cocaine
Codeine, except substances containing not more than 0.1% of codeine
Colchicum, alkaloids of; their salts
Coniine, except substances containing less than 0.1% of coniine
Cotarnine, except substances containing less than 0.2% of cotarnine
Curare, alkaloids of; curare bases
Ecgonine; its esters and ethers; except substances containing less than the equivalent of 0.1% of ecgonine
Emetine, except substances containing less than 1% of emetine
Ephedrine; its optical isomers; their salts; when contained in aerosol dispensers
Ergot, alkaloids of
Galantamine
Gelsemium, alkaloids of, except substances containing less than 0.1% of the alkaloids of gelsemium
Morphine; its esters and ethers; except substances containing less than 0.2% of morphine calculated as
anhydrous morphine
Nicotine (except when contained in (a) chewing gum or lozenges, intended to be used in nicotine replacement
therapy and containing not more than 4 mg of Nicotine per piece; or (b) patches for external application,
intended to be used in nicotine replacement therapy)
Pilocarpus, alkaloids of, except substances containing less than 0.5% of the alkaloids of pilocarpus
Rauwolfia, alkaloids of; their derivatives

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Sabadilla, alkaloids of, except substances containing less than 1% of the alkaloids of sabadilla
Thebaine, except substances containing less than 1% of thebaine
Veratrum, alkaloids of, except substances containing less than 1% of the alkaloids of veratrum
Vinca, alkaloids of
Allergen extract of Dermatophagoides pteronyssinus
Allylisopropylacetylurea
Allylprodine; its salts
Almitrine; its salts
Alogliptin; its salts
Alphadolone; its esters
Alphaxalone
Alprenolol; its salts
Alteplase
Alufibrate
Amantadine; its salts
Ambrisentan; its salts; its esters; their salts
Amidopyrine; its salts
Amifostine; its salts
Amiloride; its salts
Amineptine; its salts
Aminoglutethimide
5-Aminolevulinic acid; its salts; its derivatives; their salts
Aminopterin; its derivatives
Aminorex; its salts
para-Aminosalicylic acid; its salts; its derivatives; their salts; any compound with any substance falling within this
item
Amiodarone; its salts
Amisulpride; its salts
Amitriptyline; its salts
Amlodipine; its salts
Amrinone
Amsacrine; its salts
Amylene hydrate
Anagrelide; its salts
Anastrozole; its salts
Androgenic, oestrogenic and progestational substances, the followingBenzoestrol
Derivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their esters
Steroid compounds with androgenic or oestrogenic or progestational activity; their esters
Anidulafungin; its salts; its esters; their salts
Anileridine; its salts
Anistreplase
Antihistamine substances, the following; their salts; any compound with any substance falling within this itemAntazoline
Astemizole
Bilastine
Doxylamine
Mebhydrolin
Terfenadine
Tripelennamine
Antilymphocyte Immunoglobulins
Antimonial poisons, except substances containing less than the equivalent of 1% of antimony trioxide
Antisera, antitoxins, immunoglobulins and vaccines(a) the followingBacillus Calmette-Gurin (BCG)

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Meningococcal vaccines
Normal immunoglobulins
Pneumococcal vaccines
Rotavirus vaccines
Snake venom antisera
Staphylococcal vaccines
Streptococcal vaccines;
(b) directed against the following diseases, viruses or organismsBordetella species
Botulism
Canine infectious disease
Cholera
Diphtheria
Feline calicivirus
Feline Chlamydia psittaci
Feline immunodeficiency virus
Feline leukemia virus
Feline panleukopenia virus
Feline rhinotracheitis virus
Haemophilus influenzae type b
Hepatitis A
Hepatitis B
Herpes simplex
Herpes zoster
Human papillomavirus
Influenza
Japanese encephalitis
Measles
Mumps
Pertussis
Plague
Poliomyelitis
Rabies
Rubella
Tetanus
Typhoid
Varicella
Yellow fever
Antithymocyte Immunoglobulin
Apixaban; its salts
Apomorphine; its salts; its quaternary compounds; except substances containing less than 0.2% of apomorphine
Aprepitant; its salts
Aprindine; its salts
Aripiprazole
Arsenical poisons, except substances containing less than the equivalent of 0.01% of arsenic trioxide and except
dentifrices containing less than 0.5% of acetarsol
Arsenic trioxide when contained in pharmaceutical products
Artemether; its salts
Articaine; its salts
Asenapine; its salts; its isomers
Atazanavir; its salts
Atenolol; its salts
Atomoxetine; its salts
Atorvastatin; its salts
Atosiban; its salts

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Atovaquone
Atracurium besylate
Auranofin
Axitinib; its salts
Azacitidine; its salts
Azacyclonal; its salts
Azapropazone
Azauridine; its derivatives
Azilsartan; its salts; its esters; their salts
Aziridine; its derivatives
Baclofen
Bambuterol and its salts when contained in aerosol dispensers
Barbituric acid; its salts; its derivatives; their salts; any compound with any substance falling within this item
Basiliximab; its salts
Becaplermin; its salts
Befunolol; its salts
Belimumab
Bemiparin; its salts
Benactyzine; its salts
Benazepril, its salts
Benoxaprofen; its salts
Benserazide; its salts
Benzbromarone
Benzethidine; its salts
Benzhexol; its salts
Benzoylmorphine; its salts
Benzquinamide
Benztropine and its homologues; their salts
Benzylmorphine; its salts
Besifloxacin; its salts; its esters; their salts
Betaxolol; its salts
Bethanidine; its salts
Bevacizumab
Bezafibrate
Bezitramide; its salts
Bicalutamide; its salts
Biphenylacetic acid; its salts; its esters; except when contained in preparations intended for external use only
N-[4,4-Bis(para-fluorophenyl)butyl]piperidine, 4-substituted derivatives of; their salts
Bisoprolol; its salts
Bitolterol and its salts when contained in aerosol dispensers
Blood products derived from human blood or manufactured by biotechnology, the followingAlbumin
Antithrombins
Blood clotting factors
Fibrin
Fibrinogen
Plasma protein fractions
Thrombin
Boceprevir; its salts
Bortezomib
Bosentan; its salts
Botulinum toxin complexes
Brentuximab vedotin
Bretylium tosylate
Brimonidine; its salts

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Brinzolamide; its salts

Bromocriptine; its salts
Bromvaletone
Broncho-Vaxom
Brotizolam
Bucolome
Bufexamac
Buformin; its salts
Bumadizone; its salts
Bumetanide; its salts; its derivatives; their salts
Bupivacaine; its salts
Bupranolol; its salts
Buprenorphine; its salts
Bupropion; its salts
Buserelin; its salts
Buspirone; its salts
Busulphan; its salts
Butorphanol; its salts
Cabazitaxel; its salts; its esters; their salts
Cabergoline; its salts
Calcipotriol; its salts
Canagliflozin; its salts
Canakinumab
Candesartan; its salts; its esters; their salts
Cannabinol and its tetrahydro derivatives; their 3-alkyl homologues; any ester or ether of any substance falling within
this item
Cannabis; the resin of cannabis; extracts of cannabis; tinctures of cannabis; cannabin tennate
Capecitabine; its salts
Captodiamine; its salts
Captopril
Carbachol
Carbamazepine
Carbidopa; its salts
Carbimazole; its salts
Carboplatin
Carbromal
Carbutamide
Carisoprodol
Carmustine
Carperidine; its salts
Carprofen; its salts
Carteolol; its salts
Carvedilol; its salts
Caspofungin; its salts
Celecoxib; its salts
Celiprolol; its salts
Cerivastatin; its salts
Certolizumab pegol
Cetrorelix; its salts; its esters; their salts
Cetuximab
Chlofenamic acid; its salts
Chloral; its addition and its condensation products other than alphachloralose; any compound with any substance
falling within this item, except when contained, in the form of chloral hydrate, in preparations intended for external
application only
Chlordiazepoxide; its salts

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Chlormethiazole; its salts

Chlormezanone
Chloroform, except substances containing not more than 5% of chloroform or when in preparations not intended for
the internal treatment of human ailments
Chloroquine; its salts
Chlorothiazide and other derivatives of benzo-1,2,4-thiadiazine-7-sulphonamide 1,1-dioxide, whether hydrogenated or
not; their salts
Chlorphenoxamine; its salts
Chlorphentermine; its salts
Chlorpropamide; its salts
Chlorprothixene and other derivatives of 9-methylenethiaxanthen; their salts
Chlorthalidone and other derivatives of ortho-chlorobenzene-sulphonamide
Chlorzoxazone
Chorionic Gonadotrophin
Chymopapain
Cicletanine; its salts
Cidofovir; its salts
Cilazapril; its salts
Cilostazol; its salts
Cinacalcet; its salts
Cinepazide; its salts
Ciprofibrate; its salts
Ciprofloxacin; its salts; its esters
Cisapride
Cisatracurium besylate
Cisplatin
Citalopram; its salts
Cladribine
Clioquinol
Clobazam
Clodronic acid; its salts; its esters
Clofarabine; its salts; its esters; their salts
Clofazimine; its salts
Clofibrate
Clomiphene; its salts
Clomipramine; its salts; its derivatives; their salts
Clonidine; its salts
Clonitazene; its salts
Clopidogrel; its salts
Clorexolone
Cloridarol
Clorprenaline and its salts when contained in aerosol dispensers
Clothiapine
Clozapine; its salts
Cobicistat; its salts
Colaspase
Colfosceril; its salts
Collagen, purified
Contrast media, the following; their salts; any compound with any substance falling within this item; when contained
in preparations for parenteral useAcetrizoic acid
Diatrizoic acid
Ferucarbotran
Gadobenic acid
Gadobutrol

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Gadodiamide
Gadopentetic acid
Gadoteric acid
Iobitridol
Iocarmic acid
Iocetamic acid
Iodamide
Iodipamide
Iodised oil
Iodixanol
Iodoxamic acid
Ioglicic acid
Ioglycamic acid
Iohexol
Iomeprol
Iopamidol
Iopanoic acid
Iophendylate
Iopromide
Iothalamic acid
Iotrolan
Iotroxic acid
Ioversol
Ioxaglic acid
Ioxitalamic acid
Ipodic acid
Metrizamide
Propyliodone
Sulphur hexafluoride
Tyropanoic acid
Corifollitropin alfa
Corticorelin; its salts
Corticotrophins
Corynebacterium parvum
Crizotinib; its salts
4-Cyano-2-dimethylamino-4,4-diphenylbutane; its salts
4-Cyano-1-methyl-4-phenylpiperidine; its salts
Cyclarbamate
Cyclobenzaprine; its salts
Cyclofenil
Cyclosporin A
Cytarabine; its salts
Dabigatran etexilate; its salts
Dabrafenib; its salts
Dacarbazine
Daclizumab
Dalteparin; its salts
Dapagliflozin; its salts
Dapoxetine; its salts
Dapsone
Darbepoetin alfa
Darifenacin; its salts
Darunavir; its salts
Dasabuvir; its salts
Dasatinib; its salts

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Deanol acetamidobenzoate
Debrisoquine; its salts
Decitabine; its salts
Deferasirox; its salts; its esters; their salts
Deferiprone; its salts
Degarelix; its salts
Dehydroemetine; its salts
Demecarium bromide
Denosumab
Desferrioxamine; its salts
Desipramine; its salts
Desomorphine; its salts; its esters and ethers; their salts
Desvenlafaxine; its salts
Dexketoprofen; its salts
Dexlansoprazole; its salts
Dexmedetomidine; its salts
Dexrazoxane; its salts
Diacerein; its salts; its esters
Diampromide; its salts
Diazepam and other compounds containing the chemical structure of dihydro-1, 4-benzodiazepine substituted to any
degree; their salts
Diazoxide
Diclofenac; its salts; except when contained in preparations for external application only
Didanosine; its salts
Digitalis, glycosides of; other active principles of digitalis
Dihydralazine; its salts
Dihydrocodeine; its salts; its esters and ethers; their salts
Dihydrocodeinone; its salts
Dihydrocodeinone O-carboxymethyloxime; its salts; its esters; their salts
Dihydrocodeinone enol acetate; its salts
Dihydroergotamine; its salts, simple or complex
Dihydroetorphine; its salts
Dihydromorphine; its salts; its esters and ethers; their salts
3-(3,4-Dihydroxyphenyl)alanine; its salts
Diltiazem; its salts
Dimefline; its salts
Dimenoxadole; its salts
Dimepheptanol; its salts; its esters and ethers; their salts
Dioxaphetyl butyrate; its salts
Dipipanone; its salts
Diprenorphine; its salts
Dipyridamole
Disopyramide; its salts
Distigmine; its salts
Disulfiram
Dithienylallylamines; dithienylalkylallylamines; their salts
Dobutamine; its salts
Docetaxel; its salts
Dolutegravir; its salts
Domperidone; its salts
Donepezil; its salts
Dopamine; its salts
Dornase alfa
Dorzolamide; its salts
Dothiepin; its salts

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Doxapram; its salts

Doxazosin; its salts
Doxepin; its salts; its derivatives; their salts
Dronedarone; its salts
Droperidol
Drotrecogin alfa
Duloxetine; its salts
Dutasteride
Dyflos
Ecothiopate iodide
Ectylurea
Eculizumab
Efalizumab
Efavirenz; its salts
Eletriptan; its salts
Elosulfase alfa
Eltrombopag; its salts; its esters; their salts
Elvitegravir; its salts
Embutramide
Empagliflozin; its salts
Emtricitabine; its salts
Emylcamate
Enalapril; its salts
Enalaprilat; its salts
Enfuvirtide
Enoxacin; its salts; its esters
Enoxaparin; its salts
Enoximone
Enrofloxacin; its salts; its esters
Entacapone; its salts
Entecavir; its salts; its esters; their salts
Enzalutamide; its salts
Eplerenone
Epoetin beta
Eprosartan; its salts
Eptifibatide; its salts
Eribulin; its salts
Erlotinib; its salts
Esmolol; its salts
Esomeprazole; its salts
Etafenone; its salts
Etamivan; its salts
Etanercept
Ethacrynic acid; its salts
Ethambutol; its salts
Ethchlorvynol
Ethinamate
Ethionamide
Ethoglucid
Ethoheptazine; its salts
Ethosuximide; its salts
Ethylmorphine; its salts; its esters and ethers; their salts; except substances containing less than 0.2% of ethylmorphine
Etidronic acid; its salts
Etilefrine; its salts
Etodolac

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Etofibrate
Etomidate; its salts
Etonitazene; its salts
Etoposide; its esters
Etoricoxib; its salts
Etorphine; its salts; its esters and ethers; their salts
Etoxeridine; its salts
Etravirine
Etretinate
Etryptamine; its salts
Everolimus; its salts; its esters; their salts
Exemestane; its salts
Exenatide
Ezetimibe
Famciclovir; its salts
Fampridine; its salts
Febuxostat; its salts; its esters; their salts
Felodipine
Fenbufen
Fencamfamin; its salts
Fenclofenac; its salts
Fendiline; its salts
Fenfluramine; its salts
Fenofibrate
Fenoprofen; its salts
Fenoterol and its salts when contained in aerosol dispensers
Fenoxazoline; its salts
Fentanyl; its salts
Fentiazac; its salts
Fenticonazole; its salts
Feprazone
Fesoterodine; its salts; its esters; their salts
Filgrastim
Finasteride
Fingolimod; its salts; its esters; their salts
Flavoxate; its salts
Flecainide; its salts
Fleroxacin; its salts; its esters
Fluanisone
Fluconazole; its salts
Fludarabine; its salts
Flufenamic acid; its salts; its esters; their salts
Flumazenil
Flumethrin; its salts
Fluorouracil; its derivatives
Fluoxetine; its salts
Flupenthixol; its salts
Flurbiprofen
Fluspirilene
Flutamide
Fluvastatin
Fluvoxamine; its salts
Folinic acid; its salts
Fondaparinux; its salts
Formestane

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Formoterol and its salts when contained in aerosol dispensers

Fosaprepitant; its salts
Foscarnet trisodium hexahydrate
Fosinopril; its salts
Fosphenytoin; its salts
Fotemustine; its salts
Frusemide
Fulvestrant
Furethidine; its salts
Gabapentin; its salts
Gadoxetic acid; its salts
Gallamine; its salts; its quaternary compounds
Gallopamil; its salts
Galsulfase
Ganciclovir; its salts
Ganirelix; its salts
Gatifloxacin; its salts; its esters
Gefitinib; its salts
Gemcitabine; its salts
Gemfibrozil
Gimeracil; its salts
Glibenclamide
Glibornuride
Gliclazide
Glimepiride; its salts
Glipizide
Gliquidone
Glucagon; its salts
Glutethimide; its salts
Glycopyrronium; its salts
Glymidine
Golimumab
Gonadorelin; its salts
Goserelin; its salts
Granisetron; its salts
Grepafloxacin; its salts; its esters
Guanabenz; its salts
Guanethidine; its salts
Guanfacine; its salts
Guanidines, the followingPolymethylene diguanidines; di-para-anisyl-para-phenethylguanidine; their salts
Halofantrine; its salts
Haloperidol and other 4-substituted derivatives of N-(3-para-fluorobenzoylpropyl) piperidine
Hexachlorophane contained in medicinal products except (a) in the case of medicinal products for human use
substances containing 0.1% or less; and (b) in the case of medicinal products for animal use (i) aerosols the contents
of the container of which contain 0.1% or less; (ii) soaps and shampoos containing 2% or less; (iii) other medicinal
products containing 0.75% or less; and (c) preparations for oral administration to sheep or cattle for liver fluke
disease
Hexamethylmelamine
Hexapropymate
Hexobendine; its salts
Hydralazine; its salts
Hydrazines, the following and their alpha-methyl derivativesBenzyl hydrazine
Phenethyl hydrazine

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Phenoxyethyl hydrazine
their salts; their acyl derivatives; their salts
Hydrocyanic acid, except substances containing less than 0.15%, weight in weight, of hydrocyanic acid (HCN);
cyanides, other than ferrocyanides and ferricyanides, except substances containing less than the equivalent of 0.1%
weight in weight, of hydrocyanic acid (HCN)
Hydromorphinol; its salts; its esters and ethers; their salts
Hydromorphone; its salts; its esters and ethers; their salts
Hydroxychloroquine; its salts
Hydroxy-N,N-dimethyltryptamines; their esters and ethers; any salt of any substance falling within this item
3-Hydroxy-N-methylmorphinan; its salts; its optical isomers; their salts
3-Hydroxymorphinan; its salts; its optical isomers; their salts; their esters and ethers; their salts
3-Hydroxy-N-phenacylmorphinan; its salts; its optical isomers; their salts; their esters and ethers; their salts
Hydroxypethidine; its salts; its esters and ethers; their salts
Hydroxyphenamate
Hydroxyurea
Hydroxyzine; its salts
Ibandronic acid; its salts
Ibritumomab tiuxetan
Ibrutinib; its salts
Idelalisib; its salts
Idursulfase
Ifosfamide
Iloprost; its salts
Imatinib; its salts
Imidapril; its salts
Imiglucerase
Imipramine; its salts
Imiquimod; its salts
Indacaterol; its salts; its esters; their salts
Indinavir; its salts
Indomethacin; its salts
Indoprofen; its salts
Indoramin; its salts
Infliximab
Inosine
Inosine pranobex
Interferons
Ipilimumab
Iprindole; its salts
Irbesartan; its salts
Irinotecan; its salts
Isoaminile; its salts
Isoetharine; its salts
Isomethadone; its salts
Isoniazid; its salts; its derivatives; their salts; any compound with any substance falling within this item
Isoprenaline; its salts
Isopyrin; its salts
Isotretinoin
Isoxicam; its salts
Isradipine
Itraconazole; its salts
Ivabradine; its salts
Ketamine; its salts
Ketanserin; its salts
Ketobemidone; its salts; its esters and ethers; their salts

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Ketoconazole, except when contained in preparations for external application only

Ketophenylbutazone
Ketorolac; its salts; its esters
Labetalol; its salts
Lacidipine; its salts
Lacosamide; its salts
Lamivudine; its salts
Lamotrigine; its salts
Lanreotide; its salts
Lansoprazole
Lanthanum carbonate
Lapatinib; its salts
Laronidase
Laropiprant; its salts
Lead, compounds of, with acids from fixed oils
Ledipasvir; its salts
Leflunomide; its salts
Lenalidomide; its salts
Lepirudin; its salts
Lercanidipine; its salts
Letrozole
Leuprorelin; its salts
Levallorphan; its salts
Levetiracetam; its salts
Levosimendan; its salts
Lidoflazine
Lignocaine; its salts in mixture with tetracaine or in mixture with the salts of tetracaine
Linaclotide; its salts
Linagliptin; its salts
Linezolid; its salts
Liraglutide
Lisinopril; its salts
Lithium carbonate
Lithium sulphate
Lixisenatide
Lomefloxacin; its salts; its esters
Lomustine
Lonazolac; its salts
Lopinavir; its salts
Loracarbef; its salts
Lorcainide; its salts
Losartan; its salts
Lovastatin
Loxapine; its salts
Lumefantrine; its salts
Lysuride; its salts
Mangafodipir; its salts
Mannomustine; its salts
Maprotiline; its salts
Maraviroc; its salts
Marbofloxacin; its salts
Mazindol
Mebutamate
Mecamylamine; its salts
Meclofenamic acid; its salts

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Meclofenoxate; its salts

Medigoxin
Mefenamic acid; its salts; its esters; their salts
Mefloquine; its salts
Mefruside
Melagatran; its salts; its derivatives; their salts
Melatonin; its salts; when contained in pharmaceutical products intended to be used for the treatment of insomnia
Melitracen; its salts
Meloxicam; its salts
Memantine; its salts
Mephenesin; its esters; their salts
Mephenoxalone
Mepirizole; its salts
Mepivacaine; its salts
Meprobamate
alpha-Meprodine; its salts
beta-Meprodine; its salts
Mercaptopurine; its salts; its derivatives; their salts
Mercuric chloride, except substances containing less than 1% of mercuric chloride; mercuric iodide, except substances
containing less than 2% of mercuric iodide; nitrates of mercury, except substances containing less than the
equivalent of 3%, weight in weight, of mercury (Hg); potassiomercuric iodides, except substances containing less
than the equivalent of 1% of mercuric iodide; organic compounds of mercury, except substances, not being aerosols,
containing less than the equivalent of 0.3%, weight in weight, of mercury (Hg)
Meropenem; its salts
Mertiatide; its salts; its esters; their salts
Mesalazine; its salts
Mescaline; its salts; other derivatives of phenethylamine formed by substitution in the aromatic ring; their salts
Mesocarb; its salts
Metaflumizone; its salts
Metaraminol; its salts
Metaxalone
Metazocine; its salts; its esters and ethers; their salts
Metergoline
Metformin; its salts
Methadone; its salts
Methadyl acetate; its salts
Methaqualone; its salts
Methimazole; its salts
Methixene; its salts
Methocarbamol
Methorphan; its salts; its optical isomers; their salts; except substances containing not more than 0.1% of
dextromethorphan
Methoxsalen
Methyldesorphine; its salts; its esters and ethers; their salts
Methyldihydromorphine; its salts; its esters and ethers; their salts
Methyldopa; its esters; their salts
2-Methyl-3-morpholino-1,1-diphenylpropane carboxylic acid; its salts; its esters; their salts
Methylnaltrexone; its salts
Methylphenidate; its salts
Methylpentynol; its derivatives
alpha-Methylphenethylamine; beta-methylphenethylamine; alpha-ethylphenethylamine; beta-ethylphenethylamine;
their optical isomers; any synthetic compound structurally derived from any of those substances by substitution in
the aliphatic part or by ring closure therein (or by both such substitution and such closure) or by substitution in the
aromatic ring (with or without substitution at the nitrogen atom), except hydroxyamphetamine, methoxyphenamine,
pholedrine and N-substituted derivatives of ephedrine; any salt of any substance falling within this item

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1-Methyl-4-phenylpiperidine-4-carboxylic acid; its salts; its esters; their salts

Methyprylone
Metipranolol; its salts
Metoclopramide; its salts
Metolazone
Metopon; its salts; its esters and ethers; their salts
Metoprolol; its salts
Metyrapone; its salts
Mexiletine; its salts
Mianserin; its salts
Mibefradil; its salts
Micafungin; its salts; its esters
Midodrine; its salts
Mifepristone; its salts; its esters; their salts
Miglitol; its salts
Milnacipran; its salts
Milrinone; its salts
Minoxidil, except when contained in preparations intended for external application only and the preparations contain
not more than 5% of Minoxidil
Mirabegron; its salts; its esters; their salts
Mirtazapine; its salts
Mitobronitol
Mitopodozide; its salts
Mitotane
Mitoxantrone; its salts
Mivacurium; its salts
Mizolastine; its salts
Moclobemide; its salts
Moexipril; its salts
Mofebutazone; its salts
Molgramostim
Molindone; its salts
Montelukast; its salts
Moracizine; its salts
Moramide; its salts; its optical isomers; their salts
Moroxydine; its salts
Morpheridine; its salts
Moxifloxacin; its salts
Moxonidine; its salts
Muromonab-CD3
Mustine and any other N-substituted derivative of di-(2-chloroethyl)amine; their salts
Muzolimine
Mycophenolic acid; its salts; its esters
Myrophine; its salts
Nabumetone
Nadolol; its salts
Nadroparin; its salts
Nafarelin; its salts
Naftidrofuryl; its salts
Nalbuphine; its salts
Nalidixic acid
Nalmefene; its salts
Nalorphine; its salts
Naloxone; its salts
Naltrexone; its salts

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41

alpha-Naphthylacetic acid; its salts

Naproxen; its salts
Naratriptan; its salts
Natalizumab
Nateglinide; its salts; its esters
Nebivolol; its salts
Nefazodone; its salts
Nefopam; its salts
Nelfinavir; its salts
Neostigmine; its salts
Nepafenac; its salts
Nesiritide
Nevirapine; its salts
Nicergoline
Nicocodine; its salts
Nicotinic acid and its salts when contained in pharmaceutical products the recommended daily dose of which contains
more than 200 mg of nicotinic acid
Nifedipine
Nifenazone
Niflumic acid; its salts
Nilotinib; its salts
Nilvadipine
Nimesulide; its salts
Nimodipine
Nisoldipine
Nitrendipine
Nitromethaqualone; its salts
Nomifensine; its salts
Noracymethadol; its salts
Noramidopyrine methanesulphonate; its salts
Norcodeine; its salts; its esters and ethers; their salts
Norfloxacin; its salts; its esters
Normethadone; its salts
Normorphine; its salts; its esters and ethers; their salts
Norpipanone; its salts
Nortriptyline; its salts
Obinutuzumab; its antibody drug conjugates
Ocriplasmin
Octreotide; its salts
Ofloxacin; its salts; its esters
Olanzapine; its salts
Olmesartan; its salts; its esters; their salts
Olodaterol; its salts
Olsalazine; its salts
Omalizumab
Ombitasvir; its salts
Ondansetron; its salts
Opipramol; its salts; its derivatives; their salts
Opium, except substances containing less than 0.2% of morphine calculated as anhydrous morphine
Orciprenaline; its salts
Orgotein
Orlistat; its salts; except when contained in a pharmaceutical product of which the recommended dose is a quantity of
the product that contains not more than 60 mg of orlistat or its salts, taken 3 times a day
Orphenadrine; its salts
Oseltamivir; its salts

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42

Oteracil; its salts

Ouabain
Oxaliplatin; its salts
Oxanamide
Oxcarbazepine; its salts
Oxprenolol; its salts
Oxycodone; its salts; its esters and ethers; their salts
Oxyfedrine; its salts
Oxymorphone; its salts; its esters and ethers; their salts
Oxypertine
Oxyphenbutazone
Oxytocins
Paclitaxel
Paliperidone; its salts
Palivizumab
Palonosetron; its salts
Pamidronate; its salts
Pancuronium; its salts
Panitumumab
Pantethine; its salts
Pantoprazole; its salts
Paraldehyde
Paramethadione
Parecoxib; its salts
Pargyline; its salts
Paricalcitol; its salts; its esters; their salts
Paritaprevir; its salts
Paroxetine; its salts
Pasireotide; its salts
Pazopanib; its salts
Pefloxacin; its salts; its esters
Pegaptanib; its salts
Pegfilgrastim
Pegvisomant; its salts
Pemetrexed; its salts; its esters; their salts
Pemirolast; its salts
Pemoline; its salts
Pempidine; its salts
Penbutolol; its salts
Penciclovir; its salts
Penicillamine; its salts
Pentamidine; its salts
Pentazocine; its salts
Pentolinium; its salts
Perampanel
Pergolide; its salts
Perindoprilat; its salts; its esters; their salts
Pertuzumab
Phenacemide
Phenacetin
Phenadoxone; its salts
Phenaglycodol
Phenampromide; its salts
Phenazocine; its salts; its esters and ethers; their salts
Phenbutrazate

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Phencyclidine; its salts

Phenetidylphenacetin
Phenformin; its salts
Phenindione
Phenomorphan; its salts; its esters and ethers; their salts
Phenoperidine; its salts; its esters and ethers; their salts
Phenothiazine; its salts; its derivatives (except dimethoxanate and promethazine); their salts (except salts of
dimethoxanate and promethazine); any compound with any substance falling within this item
Phenoxybenzamine; its salts
Phenprenazone
Phenprobamate
Phentolamine; its salts
Phenylbutazone; its salts
2-Phenylcinchoninic acid; 2-salicylcinchoninic acid; their salts; their esters
5-Phenylhydantoin; its alkyl and aryl derivatives; their salts
4-Phenylpiperidine-4-carboxylic acid ethyl ester; its salts
Pholcodine; its salts; its esters and ethers; their salts; except substances containing less than 1.5% of pholcodine
Picrotoxin
Pimecrolimus
Piminodine; its salts
Pioglitazone; its salts
Pipecuronium; its salts
Pipemidic acid
Pipobroman
Piritramide; its salts
Piromidic acid; its salts
Piroxicam, except when contained in preparations for external application only
Pirprofen; its salts
Pituitary gland, the active principles of, other than corticotrophins, oxytocins and vasopressins
Pizotifen; its salts
Plerixafor; its salts
Polymethylenebistrimethylammonium salts
Pomalidomide; its salts
Poractant alfa
Posaconazole; its salts; its esters; their salts
Pralidoxime; its salts
Pramipexole; its salts
Prasugrel; its salts
Pravastatin; its salts; its esters
Prazosin; its salts
Pregabalin; its salts
Pridinol; its salts
Primaquine; its salts
Primidone
Prindolol; its salts
Probucol
Procainamide; its salts
Procarbazine; its salts
Procaterol and its salts when contained in aerosol dispensers
Procyclidine; its salts
alpha-Prodine; its salts
beta-Prodine; its salts
Proglumetacin; its salts
Proguanil; its salts
Proheptazine; its salts

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44

Promoxolane
Propafenone; its salts
Propanidid
Propiverine; its salts
Propofol
Propoxur; its salts
Propoxyphene; its salts; its optical isomers; their salts
Propranolol; its salts; its derivatives; their salts
Propylhexedrine; its salts
Propylthiouracil; its salts
Proquazone
Prostaglandins, the following and their derivativesAlprostadil
Bimatoprost
Dinoprost
Dinoprostone
Latanoprost
Misoprostol
Travoprost
Unoprostone
their salts; their esters
Prothionamide
Prothipendyl; its salts
Protirelin; its salts
Protriptyline; its salts; its derivatives; their salts
Prucalopride; its salts
Prulifloxacin; its salts; its esters; their salts
Pyrazinamide
Pyricarbate (Pyridinolcarbamate)
Pyridostigmine; its salts
Pyrimethamine
Pyrithyldione
Quetiapine; its salts
Quinagolide; its salts
Quinapril; its salts
Quinethazone
Quinidine; its salts
Quinine; its salts; its derivatives; their salts
Rabeprazole; its salts
Racecadotril; its salts
Ractopamine; its salts
Radium-223; its salts; when contained in pharmaceutical products
Raloxifene; its salts
Raltegravir; its salts
Raltitrexed; its salts
Ramipril; its salts
Ranibizumab
Ranolazine; its salts
Rasagiline; its salts
Rasburicase; its salts
Reboxetine; its salts
Recombinant human erythropoietin
Regorafenib; its salts
Remifentanil; its salts
Remoxipride; its salts

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45

Repaglinide; its salts; its esters

Reproterol and its salts when contained in aerosol dispensers
Rescinnamine
Reteplase
Retigabine; its salts
Reviparin; its salts
Ribavirin; its salts
Rilmenidine; its salts
Rilpivirine; its salts
Riluzole; its salts
Rimiterol and its salts when contained in aerosol dispensers
Rimonabant; its salts
Riociguat; its salts
Risedronic acid; its salts
Risperidone
Ritodrine; its salts
Ritonavir; its salts
Rituximab
Rivaroxaban; its slats
Rivastigmine; its salts
Rizatriptan; its salts
Rocuronium; its salts
Rofecoxib; its salts
Roflumilast; its salts
Romiplostim
Ropinirole; its salts
Ropivacaine; its salts
Rosiglitazone; its salts
Rosoxacin; its salts
Rosuvastatin; its salts
Rotigotine; its salts
Rufinamide; its salts
Ruxolitinib; its salts
Salbutamol and its salts, except when contained in aerosol dispensers
Salmeterol and its salts when contained in aerosol dispensers
Saquinavir; its salts
Saxagliptin; its salts
Sermorelin; its salts
Sertindole; its salts
Sertraline; its salts
Sevelamer; its salts
Sibutramine; its salts; any compound containing the chemical structure of 1-[1-(4-Chlorophenyl)cyclobutyl]-3methylbutan-1-amine substituted to any degree or without substitution; its salts
Sildenafil; its salts; any compound containing the chemical structure of 5-(2-ethoxyphenyl)-1-methyl-3-propyl-1Hpyrazolo[4,3-d]pyrimidin-7(6H)-one substituted to any degree or without substitution; its salts
Simvastatin
Sirolimus; its salts
Sitagliptin; its salts
Sodium aurothiomalate
Sodium nitroprusside
Sofosbuvir; its salts
Solifenacin; its salts; its esters; their salts
Somatostatin
Sorafenib; its salts
Sotalol; its salts

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46

Sparfloxacin; its salts; its esters

Sparteine; its salts
Spinosad
Spironolactone
Stavudine; its salts
Streptokinase
Strontium ranelate
Strophanthus, glycosides of
Styramate
Sulindac
Sulphinpyrazone
Sulphonal; alkyl sulphonals
Sulpiride
Sultopride
Sumatriptan; its salts
Sunitinib; its salts
Suprarenal gland, the active principles of, except adrenaline and noradrenaline (other than when contained in aerosol
dispensers); their salts; except salts of adrenaline (other than when contained in aerosol dispensers); their
derivatives; their salts; except hydrocortisone and its salts when contained in preparations intended for external
application only at not more than 1%; except beclomethasone and its salts when contained in aerosol dispensers and
except clobetasone butyrate when contained in preparations intended for external application only at not more than
0.05%
Sutoprofen; its salts
Suxamethonium; its salts
Syrosingopine
Tacrine; its salts
Tacrolimus
Tadalafil; its salts; any compound containing the chemical structure of 6-(Benzo[1,3]dioxol-5-yl)-2,3,6,7,12, 12ahexahydropyrazino[1,2:1,6]pyrido[3,4-b]indole-1,4-dione substituted to any degree or without substitution; its
salts
Tafluprost
Tamoxifen; its salts
Tapentadol; its salts
Tazarotene; its salts
Tegaserod; its salts
Telbivudine; its salts
Telmisartan; its salts
Temozolomide; its salts
Temsirolimus; its salts; its esters
Tenecteplase; its salts
Teniposide
Tenofovir; its salts; its esters; their salts
Tenoxicam
Terazosin; its salts
Terbinafine; its salts; except when contained in preparations for external application only
Terbutaline and its salts when contained in aerosol dispensers
Teriflunomide; its salts
Teriparatide; its salts
Terodiline; its salts
Tertatolol; its salts
Tetrabenazine; its salts
Tetracaine (being an amino alcohol esterified with a derivative of benzoic acid); its salts in mixture with lignocaine or
in mixture with the salts of lignocaine
Tetracosactide; its salts
Thalidomide; its salts

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47

Thallium, salts of
Theofibrate
Thiacetazone
Thiocarlide; its salts
Thioctic acid; its salts; its derivatives; when contained in pharmaceutical products
Thiotepa
Thymosin alpha 1
Thyroid gland, the active principles of; their salts
Thyrotropin alfa
Tiagabine; its salts; its esters; their salts
Tianeptine; its salts; its esters; their salts
Tiapride; its salts
Ticagrelor; its salts; its esters; their salts
Ticlopidine; its salts
Tiletamine; its salts
Tilidate; its salts
Tiludronic acid; its salts
Timolol; its salts
Tinoridine; its salts
Tinzaparin; its salts
Tiotropium; its salts
Tiratricol; its salts
Tirofiban; its salts
Tizanidine; its salts
Tocainide; its salts
Tocilizumab
Todralazine; its salts
Tofacitinib; its salts
Tofenacin; its salts
Tolazamide
Tolbutamide
Tolcapone; its salts
Tolfenamic acid; its salts
Tolmetin; its salts
Tolperisone; its salts
Tolterodine; its salts
Tolvaptan
para-Tolylmethylcarbinol nicotinic acid ester
Topiramate; its salts
Topotecan; its salts
Torasemide
Trabectedin; its salts; its esters
Tramadol; its salts
Trandolapril; its salts
Tranexamic acid, except when contained in toothpaste at 0.05% by weight
Tranylcypromine; its salts
Trastuzumab; its antibody drug conjugates
Trazodone; its salts
Tretamine; its salts
Tretinoin
Triamterene; its salts
Triaziquone
Tribromoethyl alcohol
2,2,2-Trichloroethyl alcohol, esters of; their salts
Trifluridine; its salts

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48

Trilostane
Trimeperidine; its salts
Trimetaphan; its salts
Trimetazidine; its salts
Trimethadione
Trimethoprim
Trimetozine
Trimetrexate; its salts
Trimipramine; its salts
Trioxsalen
Triptorelin; its salts
Tromantadine; its salts; except when contained in pharmaceutical products labelled for the treatment of cold sores
only
Tropisetron; its salts
Trovafloxacin; its salts; its derivatives; their salts
Tulobuterol and its salts when contained in aerosol dispensers
Tybamate
Umeclidinium; its salts
Urapidil; its salts
Urethane
Urokinase
Ustekinumab
Valaciclovir; its salts
Valdecoxib; its salts
Valganciclovir; its salts
Valnoctamide
Valproic acid; its salts; its esters
Valsartan; its salts
Vandetanib; its salts
Vardenafil; its salts; any compound containing the chemical structure of 2-(2-ethoxyphenyl)-5-methyl-7propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one substituted to any degree or without substitution; its salts
Varenicline; its salts
Vasopressins
Vecuronium; its salts
Vedolizumab
Vemurafenib; its salts
Venlafaxine; its salts
Veralipride; its salts
Verapamil; its salts
Vernakalant; its salts
Verteporfin; its salts
Vidarabine; its salts
Vigabatrin
Vilanterol; its salts
Vildagliptin; its salts
Viloxazine; its salts
Vindesine; its salts
Vinorelbine; its salts
Vismodegib; its salts
Vitamin A and its esters when contained in pharmaceutical products the recommended daily dose of which contains
not less than 10000 international units of vitamin A
Voriconazole; its salts
Vortioxetine; its salts
Warfarin; its salts
Xamoterol; its salts

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49

Xylazine; its salts

Zafirlukast
Zalcitabine; its salts
Zaleplon; its salts
Zanamivir; its salts
Zidovudine
Zimelidine; its salts
Zipeprol; its salts
Ziprasidone; its salts
Zofenopril; its salts
Zolazepam; its salts
Zoledronic acid; its salts
Zolmitriptan; its salts
Zolpidem; its salts
Zomepirac; its salts
Zopiclone
Zoxazolamine; its salts
(L.N. 137 of 1978; L.N. 369 of 1980; L.N. 415 of 1984; L.N. 129 of 1986; L.N. 130 of 1987; L.N. 197 of 1989;
L.N. 128 of 1990; L.N. 384 of 1992; L.N. 262 of 1995; L.N. 130 of 1998; L.N. 22 of 1999; L.N. 202 of 1999;
L.N. 30 of 2000; L.N. 138 of 2000; L.N. 235 of 2000; L.N. 296 of 2000; L.N. 51 of 2001; L.N. 143 of 2001;
L.N. 173 of 2001; L.N. 287 of 2001; L.N. 56 of 2002; L.N. 112 of 2002; L.N. 132 of 2002; L.N. 170 of 2002;
L.N. 237 of 2002; L.N. 73 of 2003; L.N. 179 of 2003; L.N. 181 of 2003; L.N. 273 of 2003; L.N. 276 of 2003;
L.N. 74 of 2004; L.N. 135 of 2004; L.N. 191 of 2004; L.N. 11 of 2005; L.N. 72 of 2005; L.N. 114 of 2005; L.N.
212 of 2005; L.N. 25 of 2006; L.N. 122 of 2006; L.N. 178 of 2006; L.N. 223 of 2006; L.N. 277 of 2006; L.N.
41 of 2007; L.N. 98 of 2007; L.N. 143 of 2007; L.N. 208 of 2007; L.N. 239 of 2007; L.N. 61 of 2008; L.N. 113
of 2008; L.N. 197 of 2008; L.N. 234 of 2008; L.N. 282 of 2008; L.N. 90 of 2009; L.N. 147 of 2009; L.N. 199 of
2009; L.N. 258 of 2009; L.N. 11 of 2010; L.N. 32 of 2010; L.N. 81 of 2010; L.N. 104 of 2010; L.N. 140 of
2010; L.N. 23 of 2011; L.N. 127 of 2011; L.N. 33 of 2012; L.N. 124 of 2012; L.N. 179 of 2012; L.N. 19 of
2013; L.N. 94 of 2013; L.N. 98 of 2013; L.N. 125 of 2013; L.N. 158 of 2013; L.N. 195 of 2013; L.N. 39 of
2014; L.N. 134 of 2014; 2 of 2015 s. 66; L.N. 34 of 2015; L.N. 67 of 2015; L.N. 100 of 2015; L.N. 193 of 2015)
DIVISION B
Barium, salts of, except barium sulphate
Dinitronaphthols; dinitrophenols; dinitrothymols
meta-Nitrophenol; ortho-nitrophenol; para-nitrophenol
Phosmet
(L.N. 195 of 1977; L.N. 137 of 1978; L.N. 129 of 1986; L.N. 262 of 1995; L.N. 41 of 2007)
________________________________________________________________________________
Note:
* (2 of 2015 s. 66)
Schedule:

ARTICLES EXEMPTED BY REGULATION 8 FROM

THE PROVISIONS OF THE ORDINANCE AND OF
THESE REGULATIONS

E.R. 1 of 2015

29/01/2015

[regulation 8]
GROUP I
GENERAL EXEMPTIONS
Adhesives; anti-fouling compositions; builders' materials; ceramics; distempers; electrical valves; enamels;
explosives; fillers; fireworks; fluorescent lamps; glazes; glues; inks; lacquer solvents; loading materials; matches;

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50

motor fuels and lubricants; paints other than pharmaceutical paints; photographic paper; pigments; plastics;
propellants; rubber; varnishes
(L.N. 195 of 1977; L.N. 262 of 1995)
GROUP II
SPECIAL EXEMPTIONS
DIVISION A
(L.N. 41 of 2007)
Poison
Alkaloids, the followingBrucine
Emetine
Lobelia, alkaloids of
Pilocarpus, alkaloids of
Pomegranate, alkaloids of
Stavesacre, alkaloids of
para-Aminobenzenesulphonamide; its salts;
derivatives
of
paraaminobenzenesulphonamide having any of
the hydrogen atoms of the para amino group
or of the sulphonamide group substituted by
another radical; their salts
Androgenic, oestrogenic and progestational
substances, the followingBenzoestrol
Derivatives of stilbene,
dibenzyl or naphthalene
with oestrogenic
activity; their esters
Steroid compounds with
androgenic or
oestrogenic or
progestational activity;
their esters

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Substance or article in which exempted

Surgical spirit containing not more than 0.015% of brucine
Ipecacuanha; extracts and tinctures of ipecacuanha; substances
containing less than 0.05% of emetine
Preparations for the relief of asthma in the form of cigarettes,
smoking mixtures or fumigants; substances containing less than
0.1% of the alkaloids of lobelia
Substances containing less than 0.025% of the alkaloids of
pilocarpus, preparations containing not more than 2%, weight of
the sulphate salt of transpilosine (L.N. 137 of 1978)
Pomegranate bark
Soaps; ointments lotions for external use
Feeding stuffs containing not more than 0.5% of total
sulphonamides

Preparations intended for external application only; except

preparations containing more than 4 milligrammes of
oestrogenic substance per 100 grammes of inert substance and
preparations containing testosterone or its esters (L.N. 90 of
2009)

preparations intended to be taken orally for contraceptive purposes

only which contain not more than the following per dose0.15 milligrammes Desogestrel;
3.00 milligrammes Drospirenone;
0.05 milligrammes Ethinyloestradiol;
0.10 milligrammes Gestodene;
0.25 milligrammes Levonorgestrel;
2.50 milligrammes Lynoestrenol;
0.05 milligrammes Mestranol;
1.00 milligrammes Norethisterone;
0.25 milligrammes Norgestimate; and
0.50 milligrammes Norgestrel,
multivitamin preparations with or without minerals containing
not more than 0.01 mg. ethinyloestradiol or not more than 2.5
mg. Methyltestosterone or both in each dosage form (L.N. 369

51

Antihistamine substances; their salts; any

compound with any substance falling within
this item
Arsenical poisons

Barbituric acid; its salts; its derivatives; their

salts; any compound with any substance
falling within this item
Chloroform
Clioquinol
Creosote obtained from wood
Diperodon; its salts
Hydrocyanic acid

Lead acetate
Lead, compounds of
Lignocaine; its salts
Mercury, nitrates of
Mescaline; its salts
Phenols

Phenyl mercuric salts

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of 1980; L.N. 112 of 2002)

Preparations intended for external application only and
preparations containing not more than 1% of anti-histamine
substances for application in the nose or eye
Poultry or pig feeding stuffs containing not more than 0.005% of
4-hydroxy-3-nitrophenylarsonic acid and not containing any
other arsenical poison; animal feeding stuffs containing not more
than 0.01% of arsenilic acid and not containing any other
arsenical poison; poultry feeding stuffs containing not more than
0.0375% of carbarsone and not containing any other arsenical
poison;
medicines containing arsenic in a non-assimilable form
Self-heating preparations, in aerosol dispensers intended for
external application only, containing 1, 5-diethyl-2-thio-4, 6pyrimidine-dione and not containing any other substance
mentioned opposite hereto in the first column
Substances containing less than 1% of chloroform; solid
preparations; toothpaste
Preparations intended for external application only (L.N. 137 of
1978)
Substances containing less than 50% of creosote obtained from
wood
Preparations intended for external application only, containing not
more than 1% of diperodon, calculated as anhydrous base
Preparations of wild cherry; in reagent kits supplied for medical or
veterinary purposes; substances containing less than the
equivalent of 0.1%, weight in weight, of hydrocyanic acid
(HCN)
Substances containing less than 4% of lead acetate
Machine-spread plasters
Preparations intended for external application only, containing not
more than 0.7% of Lignocaine or its salts (L.N. 369 of 1980)
Ointments containing less than the equivalent of 3%, weight in
weight, of mercury (Hg)
Living plants
Butylated hydroxytoluene, carvacrol, creosote obtained from coal
tar;
essential oils in which phenols occur naturally;
medicines containing less than 1% of phenols;
nasal sprays, mouth washes, pastilles, lozenges, capsules,
pessaries, ointments or suppositories containing less than 2.5%
of phenols, in reagent kits supplied for medical or veterinary
purposes;
smelling bottles;
soaps for washing;
solid substances, other than pastilles, lozenges, capsules, pessaries,
ointments and suppositories, containing less than 60% of
phenols;
Tar (coal or wood), crude or refined;
para-tertiary amylphenol;
tertiary butylcresol;
para-tertiary butylphenol;
para-(1, 1, 3, 3-tetramethylbutyl) phenol;
thymol
Toilet, cosmetic and therapeutic preparations containing not more

52

Picric acid
Podophyllum resin
Procaine
Quinine; its salts; its derivatives; their salts

Sodium ethyl mercurithio-salicylate

Sodium fluoride

than 0.01% of phenyl mercuric salts as preservative; antiseptic

dressings on toothbrushes; in textiles containing not more than
0.01% of phenyl mercuric salts as a bacteriostat and fungicide
Substances containing less than 5% of picric acid
Preparations containing not more than 1.5%, weight in weight, of
podophyllum resin
Feeding stuffs containing any substance to which the Antibiotics
Ordinance (Cap 137) for the time being applies
Preparations containing not more than 1% of quinine, its salts, its
derivatives or their salts; soft drinks, wines or tonic wines;
preparations containing not more than 15% of quinine, its salts,
its derivatives or their salts for use in the manufacture of soft
drinks, wines, tonic wines, or confectionery (L.N. 130 of 1987)
Therapeutic substances containing less than 0.1% of sodium ethyl
mercurithiosalicylate as a preservative
Substances containing less than 3% of sodium fluoride as a
preservative; dentifrices containing not more than 0.33% of
sodium fluoride; mouth wash tablets containing not more than
0.2% of sodium fluoride and liquid mouth washes containing not
more than 0.05% thereof; tablets containing not more than
0.016%, weight in weight, of sodium fluoride and intended,
when chewed to prevent tooth decay (L.N. 202 of 1999; E.R. 1
of 2015)
(L.N. 138 of 2000; L.N. 41 of 2007)
DIVISION B
(L.N. 41 of 2007)

Acetanilide; alkyl acetanilides

Ammonia

Antimony, chlorides of
Arsenical poisons
Barium, salts of
gamma-Benzene hexachloride
Diamines, the following;
their salts-phenylene diamines; toluene
diamines; other alkylated-benzene diamines
Dinitrophenols
Disulfiram
Formaldehyde
Formic acid

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Substances not being preparations for the treatment of human

ailments
Substances not being solutions of ammonia or preparations
containing solutions of ammonia; substances containing less
than 5%, weight in weight, of ammonia (NH3); refrigerators;
smelling bottles
Polishes
Pyrites ores or sulphuric acid containing arsenical poisons as
natural impurities
Witherite other than finely ground witherite; barium carbonate
bonded to charcoal for case hardening; fire extinguishers
containing barium chloride
Substances containing not more than 5% by weight of gammabenzene hexachloride; when used in agriculture or horticulture
(L.N. 195 of 1977)
Substances other than preparations for the dyeing of hair
Substances not being preparations for the treatment of human
ailments
Substances not being preparations for the treatment of human
ailments
Substances containing less than 5%, weight in weight, of
formaldehyde (H. CHO); photographic glazing or hardening
solutions
Substances containing less than 5%, weight in weight, of formic
acid (H. COOH)

53

Hydrochloric acid
Mercuric chloride
Mercuric chloride; mercuric iodide; organic
compounds of mercury
Mercury, oxides of
Nicotine

Nitric acid
Nitrobenzene
para-Nitrobenzyl cyanide
para-Nitrophenol
Oxalic acid; metallic oxalates
Phosphoric acid
Potassium hydroxide
Sodium hydroxide
Sodium nitrite
Sodium silicofluoride
Sulphaquinoxaline; its salts
Sulphuric acid

Schedule:

Substances containing less than 9%, weight in weight, of

hydrochloric acid (HCl)
Batteries
Dressings on seeds or bulbs
Canker and wound paints (for trees) containing not more than 3%,
weight in weight, of yellow mercuric oxide
Tobacco; preparations in aerosol dispensers containing not more
than 0.2% of nicotine, weight in weight; other liquid
preparations and solid preparations with a soap base, containing
not more than 7.5% of nicotine, weight in weight
Substances containing less than 9%, weight in weight, of nitric
acid (HNO2)
Substances containing less than 0.1% of nitrobenzene; soaps
containing less than 1 % of nitrobenzene; polishes
Photographic solutions containing less than the equivalent of 0.1%,
weight in weight, of hydrocyanic acid (HCN)
Preparations for use in agriculture or horticulture containing not
more than 0.5% of para-Nitrophenol as preservative
Laundry blue; polishes; cleaning powders or scouring products
containing the equivalent of not more than 10% of oxalic acid
dihydrate
Substances containing phosphoric acid, not being descaling
preparations containing more than 50%, weight in weight, of
ortho-phosphoric acid (L.N. 137 of 1978)
Substances containing the equivalent of less than 17% of total
caustic alkalinity expressed as potassium hydroxide;
accumulators, batteries
Substances containing the equivalent of less than 12% of total
caustic alkalinity expressed as sodium hydroxide
Substances other than preparations containing more than 0.1% of
sodium nitrite for the destruction of rats or mice
Substances containing less than 3% of sodium silicofluoride as
preservative
Preparations for the destruction of mice and rats containing not
more than the equivalent of 0.5% of sulphaquinoxaline
Substances containing less than 9%, weight in weight, of sulphuric
acid (H2SO4); accumulators; batteries and sealed containers in
which sulphuric acid is packed together with car batteries for use
in those batteries; fire extinguishers
(L.N. 195 of 1977; L.N. 262 of 1995)
L.N. 193 of 2015 09/10/2015
[regulations 3 & 9 & 5th Schedule
& Schedule 10]
(2 of 2015 s. 67)

SUBSTANCES REQUIRED BY REGULATION 9 TO BE SOLD BY RETAIL ONLY UPON

A PRESCRIPTION GIVEN BY A REGISTERED MEDICAL PRACTITIONER,
REGISTERED DENTIST OR REGISTERED
VETERINARY SURGEON
(L.N. 614 of 1997)

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54

Division A
(L.N. 39 of 2014)
Abacavir; its salts
Abatacept
Abciximab
Abiraterone; its salts
Acamprosate; its salts
Acarbose; its salts
Acebutolol; its salts
Acemetacin; its salts
Acetanilide; alkyl acetanilides
Acetazolamide; its salts
Acetohexamide
Acetorphine; its salts; its esters and ethers; their salts
Acetylcarbromal
Acetyldihydrocodeine; its salts
Aciclovir; its salts; except when contained in skin creams packed in a package size of not more than 3 grams and
labelled for the treatment of cold sores only
Acipimox; its salts
Acitretin; its salts; its esters
Adalimumab
Adapalene; its salts; its esters
Adefovir; its salts; its esters; their salts
Afatinib; its salts
Aflibercept
Agalsidase beta
Agomelatine; its salts
Alclofenac; its complexes
Alcuronium; its salts
Aldesleukin
Alefacept
Alemtuzumab
Alendronic acid; its salts
Alfuzosin; its salts
Alglucosidase alfa
Aliskiren; its salts; its esters; their salts
Alizapride; its salts
Alkaloids, the following; their quaternary compounds; any salt, simple or complex, of any substance falling within the
followingCalabar bean, alkaloids of
Codeine, except substances containing less than 0.2% of codeine
Colchicum, alkaloids of; their salts
Coniine, except substances containing less than 0.1% of coniine
Cotarnine, except substances containing less than 0.2% of cotarnine
Curare, alkaloids of; curare bases
Emetine, except substances containing less than 1% of emetine
Ephedrine; its optical isomers; their salts; when contained in aerosol dispensers
Ergot, alkaloids of
Galantamine
Gelsemium, alkaloids of, except substances containing less than 0.1% of the alkaloids of gelsemium
Pilocarpus, alkaloids of, except substances containing less than 0.5% of the alkaloids of pilocarpus
Rauwolfia, alkaloids of; their salts; derivatives of the alkaloids of rauwolfia; their salts
Sabadilla, alkaloids of, except substances containing less than 1% of the alkaloids of sabadilla
Veratrum, alkaloids of, except substances containing less than 1% of the alkaloids of veratrum

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Vinca, alkaloids of
Allergen extract of Dermatophagoides pteronyssinus
Allylisopropylacetylurea
Almitrine; its salts
Alogliptin; its salts
Alphadolone; its esters
Alphaxalone
Alprenolol; its salts
Alteplase
Alufibrate
Amantadine; its salts
Ambrisentan; its salts; its esters; their salts
Amidopyrine; its salts
Amifostine; its salts
Amiloride; its salts
Amineptine; its salts
para-Aminobenzenesulphonamide; its salts; derivatives of para-aminobenzenesulphonamide having any of the
hydrogen atoms of the para-amino group or of the sulphonamide group substituted by another radical; their salts;
except contained in preparations intended for external application or surgical dressings or in preparations for the
prevention and treatment of diseases in poultry
Aminoglutethimide
5-Aminolevulinic acid; its salts; its derivatives; their salts
Aminopterin; its derivatives
Aminorex; its salts
para-Aminosalicylic acid; its salts; its derivatives; their salts; any compound with any substance falling within this
item
Amiodarone; its salts
Amisulpride; its salts
Amitriptyline; its salts
Amlodipine; its salts
Amrinone
Amsacrine; its salts
Amylene hydrate
Anagrelide; its salts
Anastrozole; its salts
Androgenic, oestrogenic and progestational substances, the followingBenzoestrol
Derivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their esters
Steroid compounds with androgenic or oestrogenic or progestational activity; their esters
Anidulafungin; its salts; its esters; their salts
Anistreplase
Antihistamine substances, the following; their salts; any compound with any substance falling within this itemAntazoline
Astemizole
Bilastine
Doxylamine
Mebhydrolin
Terfenadine
Tripelennamine
Antilymphocyte Immunoglobulins
Antisera, antitoxins, immunoglobulins and vaccines(a) the followingBacillus Calmette-Gurin (BCG)
Meningococcal vaccines
Normal immunoglobulins

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Pneumococcal vaccines
Rotavirus vaccines
Snake venom antisera
Staphylococcal vaccines
Streptococcal vaccines;
(b) directed against the following diseases, viruses or organismsBordetella species
Botulism
Canine infectious disease
Cholera
Diphtheria
Feline calicivirus
Feline Chlamydia psittaci
Feline immunodeficiency virus
Feline leukemia virus
Feline panleukopenia virus
Feline rhinotracheitis virus
Haemophilus influenzae type b
Hepatitis A
Hepatitis B
Herpes simplex
Herpes zoster
Human papillomavirus
Influenza
Japanese encephalitis
Measles
Mumps
Pertussis
Plague
Poliomyelitis
Rabies
Rubella
Tetanus
Typhoid
Varicella
Yellow fever
Antithymocyte Immunoglobulin
Apixaban; its salts
Apomorphine; its salts; its quaternary compounds; except substances containing less than 0.2% of apomorphine
Aprepitant; its salts
Aprindine; its salts
Aripiprazole
Arsenic trioxide when contained in pharmaceutical products
Artemether; its salts
Articaine; its salts
Asenapine; its salts; its isomers
Atazanavir; its salts
Atenolol; its salts
Atomoxetine; its salts
Atorvastatin; its salts
Atosiban; its salts
Atovaquone
Atracurium besylate
Auranofin
Axitinib; its salts

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Azacitidine; its salts

Azacyclonol; its salts
Azapropazone
Azauridine; its derivatives
Azilsartan; its salts; its esters; their salts
Aziridine; its derivatives
Baclofen
Bambuterol and its salts when contained in aerosol dispensers
Barbituric acid; its salts; its derivatives; their salts; any compound with any substance falling within this item
Basiliximab; its salts
Becaplermin; its salts
Befunolol; its salts
Belimumab
Bemiparin; its salts
Benactyzine; its salts
Benazepril; its salts
Benoxaprofen; its salts
Benserazide; its salts
Benzbromarone
Benzhexol; its salts
Benzquinamide
Benztropine and its homologues; their salts
Besifloxacin; its salts; its esters; their salts
Betaxolol; its salts
Bethanidine; its salts
Bevacizumab
Bezafibrate
Bicalutamide; its salts
Biphenylacetic acid; its salts; its esters; except when contained in preparations intended for external use only
N-[4,4-Bis(para-fluorophenyl)butyl]piperidine, 4-substituted derivatives of; their salts
Bisoprolol; its salts
Bitolterol and its salts when contained in aerosol dispensers
Blood products derived from human blood or manufactured by biotechnology, the followingAlbumin
Antithrombins
Blood clotting factors
Fibrin
Fibrinogen
Plasma protein fractions
Thrombin
Boceprevir; its salts
Bortezomib
Bosentan; its salts
Botulinum toxin complexes
Brentuximab vedotin
Bretylium tosylate
Brimonidine; its salts
Brinzolamide; its salts
Bromocriptine; its salts
Bromvaletone
Broncho-Vaxom
Brotizolam
Bucolome
Bufexamac
Buformin; its salts

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Bumadizone; its salts

Bumetanide; its salts; its derivatives; their salts
Bupivacaine; its salts
Bupranolol; its salts
Buprenorphine; its salts
Bupropion; its salts
Buserelin; its salts
Buspirone; its salts
Busulphan; its salts
Butorphanol; its salts
Cabazitaxel; its salts; its esters; their salts
Cabergoline; its salts
Calcipotriol; its salts
Canagliflozin; its salts
Canakinumab
Candesartan; its salts; its esters; their salts
Capecitabine; its salts
Captodiamine; its salts
Captopril
Caramiphen; its salts; except tablets containing not more than the equivalent of 7.5 milligrammes of caramiphen base
and liquid preparations containing not more than the equivalent of 0.1% of caramiphen base
Carbachol
Carbamazepine
Carbidopa; its salts
Carbimazole; its salts
Carboplatin
Carbromal
Carbutamide
Carisoprodol
Carmustine
Carperidine; its salts
Carprofen; its salts
Carteolol; its salts
Carvedilol; its salts
Caspofungin; its salts
Celecoxib; its salts
Celiprolol; its salts
Cerivastatin; its salts
Certolizumab pegol
Cetrorelix; its salts; its esters; their salts
Cetuximab
Chlofenamic acid; its salts
Chloral; its addition and its condensation products other than alphachloralose; any compound with any substance
falling within this item, except when contained, in the form of chloral hydrate, in preparations intended for external
application only
Chlordiazepoxide; its salts
Chlormethiazole; its salts
Chlormezanone
Chloroquine; its salts
Chlorothiazide and other derivatives of benzo-1,2,4-thiadiazine-7-sulphonamide 1, 1-dioxide, whether hydrogenated
or not; their salts
Chlorphenoxamine; its salts
Chlorphentermine; its salts
Chlorpropamide; its salts
Chlorprothixene and other derivatives of 9-methylenethiaxanthen; their salts

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Chlorthalidone and other derivatives of ortho-chlorobenzene sulphonamide

Chlorzoxazone
Chorionic Gonadotrophin
Chymopapain
Cicletanine; its salts
Cidofovir; its salts
Cilazapril; its salts
Cilostazol; its salts
Cinacalcet; its salts
Cinepazide; its salts
Ciprofibrate; its salts
Ciprofloxacin; its salts; its esters
Cisapride
Cisatracurium besylate
Cisplatin
Citalopram; its salts
Cladribine
Clioquinol
Clobazam
Clodronic acid; its salts; its esters
Clofarabine; its salts; its esters; their salts
Clofazimine; its salts
Clofibrate
Clomiphene; its salts
Clomipramine; its salts; its derivatives; their salts
Clonidine; its salts
Clopidogrel; its salts
Clorexolone
Cloridarol
Clorprenaline and its salts when contained in aerosol dispensers
Clothiapine
Clozapine; its salts
Cobicistat; its salts
Colaspase
Colfosceril; its salts
Collagen, purified
Contrast media, the following; their salts; and compound with any substance falling within this item; when contained
in preparations for parenteral useAcetrizoic acid
Diatrizoic acid
Ferucarbotran
Gadobenic acid
Gadobutrol
Gadodiamide
Gadopentetic acid
Gadoteric acid
Iobitridol
Iocarmic acid
Iocetamic acid
Iodamide
Iodipamide
Iodised oil
Iodixanol
Iodoxamic acid
Ioglicic acid

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60

Ioglycamic acid
Iohexol
Iomeprol
Iopamidol
Iopanoic acid
Iophendylate
Iopromide
Iothalamic acid
Iotrolan
Iotroxic acid
Ioversol
Ioxaglic acid
Ioxitalamic acid
Ipodic acid
Metrizamide
Propyliodone
Sulphur hexafluoride
Tyropanoic acid
Corifollitropin alfa
Corticorelin; its salts
Corticotrophins
Corynebacterium parvum
Crizotinib; its salts
Cyclarbamate
Cyclobenzaprine; its salts
Cyclofenil
Cyclosporin A
Cytarabine; its salts
Dabigatran etexilate; its salts
Dabrafenib; its salts
Dacarbazine
Daclizumab
Dalteparin; its salts
Dapagliflozin; its salts
Dapoxetine; its salts
Dapsone
Darbepoetin alfa
Darifenacin; its salts
Darunavir; its salts
Dasabuvir; its salts
Dasatinib; its salts
Deanol acetamidobenzoate
Debrisoquine; its salts
Decitabine; its salts
Deferasirox; its salts; its esters; their salts
Deferiprone; its salts
Degarelix; its salts
Dehydroemetine; its salts
Demecarium bromide
Denosumab
Desferrioxamine; its salts
Desipramine; its salts
Desvenlafaxine; its salts
Dexketoprofen; its salts
Dexlansoprazole; its salts

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Dexmedetomidine; its salts

Dexrazoxane; its salts
Diacerein; its salts; its esters
Diazepam and other compounds containing the chemical structure of dihydro-1, 4-benzodiazepine substituted to any
degree; their salts
Diazoxide
Diclofenac; its salts; except when contained in preparations for external application only
Didanosine; its salts
Digitalis, glycosides of; other active principles of digitalis
Dihydralazine; its salts
Dihydroergotamine; its salts, simple or complex
Dihydroetorphine; its salts
3-(3,4-Dihydroxyphenyl)alanine; its salts
Diltiazem; its salts
Dimefline; its salts
Diprenorphine; its salts
Dipyridamole
Disopyramide; its salts
Distigmine; its salts
Disulfiram
Dithienylallylamines; dithienylalkylallylamines; their salts; except diethylthiambutene, dimethylthiambutene and
ethylmethylthiambutene
Dobutamine; its salts
Docetaxel; its salts
Dolutegravir; its salts
Domperidone; its salts
Donepezil; its salts
Dopamine; its salts
Dornase alfa
Dorzolamide; its salts
Dothiepin; its salts
Doxapram; its salts
Doxazosin; its salts
Doxepin; its salts; its derivatives; their salts
Dronedarone; its salts
Droperidol
Drotrecogin alfa
Duloxetine; its salts
Dutasteride
Ecothiopate iodide
Ectylurea
Eculizumab
Efalizumab
Efavirenz; its salts
Eletriptan; its salts
Elosulfase alfa
Eltrombopag; its salts; its esters; their salts
Elvitegravir; its salts
Embutramide
Empagliflozin; its salts
Emtricitabine; its salts
Emylcamate
Enalapril; its salts
Enalaprilat; its salts
Enfuvirtide

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Enoxacin; its salts; its esters

Enoxaparin; its salts
Enoximone
Enrofloxacin; its salts; its esters
Entacapone; its salts
Entecavir; its salts; its esters; their salts
Enzalutamide; its salts
Eplerenone
Epoetin beta
Eprosartan; its salts
Eptifibatide; its salts
Eribulin; its salts
Erlotinib; its salts
Esmolol; its salts
Esomeprazole; its salts
Etafenone; its salts
Etamivan; its salts
Etanercept
Ethacrynic acid; its salts
Ethambutol; its salts
Ethchlorvynol
Ethinamate
Ethionamide
Ethoglucid
Ethoheptazine; its salts
Ethosuximide; its salts
Ethylnoradrenaline and its salts when contained in aerosol dispensers
Etidronic acid; its salts
Etilefrine; its salts
Etodolac
Etofibrate
Etomidate; its salts
Etoposide; its esters
Etoricoxib; its salts
Etravirine
Etretinate
Etryptamine; its salts
Everolimus; its salts; its esters; their salts
Exenatide
Exemestane; its salts
Ezetimibe
Famciclovir; its salts
Fampridine; its salts
Febuxostat; its salts; its esters; their salts
Felodipine
Fenbufen
Fencamfamin; its salts
Fenclofenac; its salts
Fendiline; its salts
Fenfluramine; its salts
Fenofibrate
Fenoprofen; its salts
Fenoterol and its salts when contained in aerosol dispensers
Fenoxazoline; its salts
Fentiazac; its salts

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Fenticonazole; its salts

Feprazone
Fesoterodine; its salts; its esters; their salts
Filgrastim
Finasteride
Fingolimod; its salts; its esters; their salts
Flavoxate; its salts
Flecainide; its salts
Fleroxacin; its salts; its esters
Fluanisone
Fluconazole; its salts
Fludarabine; its salts
Flufenamic acid; its salts; its esters; their salts
Flumazenil
Flumethrin; its salts
Fluorouracil; its derivatives
Fluoxetine; its salts
Flupenthixol; its salts
Flurbiprofen
Fluspirilene
Flutamide
Fluvastatin
Fluvoxamine; its salts
Folinic acid; its salts
Fondaparinux; its salts
Formestane
Formoterol and its salts when contained in aerosol dispensers
Fosaprepitant; its salts
Foscarnet trisodium hexahydrate
Fosinopril; its salts
Fosphenytoin; its salts
Fotemustine; its salts
Frusemide
Fulvestrant
Gabapentin; its salts
Gadoxetic acid; its salts
Gallamine; its salts; its quaternary compounds
Gallopamil; its salts
Galsulfase
Ganciclovir; its salts
Ganirelix; its salts
Gatifloxacin; its salts; its esters
Gefitinib; its salts
Gemcitabine; its salts
Gemfibrozil
Gimeracil; its salts
Glibenclamide
Glibornuride
Gliclazide
Glimepiride; its salts
Glipizide
Gliquidone
Glucagon; its salts
Glutethimide; its salts
Glycopyrronium; its salts

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Glymidine
Golimumab
Gonadorelin; its salts
Goserelin; its salts
Granisetron; its salts
Grepafloxacin; its salts; its esters
Guanabenz; its salts
Guanethidine; its salts
Guanfacine; its salts
Halofantrine; its salts
Halofuginone; its salts; except for incorporation in feed for chickens for fattening at levels not exceeding 3 parts per
million
Haloperidol and other 4-substituted derivatives of N-(3-para-fluorobenzoylpropyl) piperidine
Hexamethylmelamine
Hexapropymate
Hexobendine; its salts
Hydralazine; its salts
Hydrazines, the following and their alpha-methyl derivativesBenzyl hydrazine
Phenethyl hydrazine
Phenoxyethyl hydrazine
their salts; their acyl derivatives; their salts
Hydroxychloroquine; its salts
Hydroxy-N,N-dimethyltryptamines; their esters and ethers; any salt of any substance falling within this item
Hydroxyphenamate
Hydroxyurea
Hydroxyzine; its salts
Ibandronic acid; its salts
Ibritumomab tiuxetan
Ibrutinib; its salts
Idelalisib; its salts
Idursulfase
Ifosfamide
Iloprost; its salts
Imatinib; its salts
Imidapril; its salts
Imiglucerase
Imipramine; its salts
Imiquimod; its salts
Indacaterol; its salts; its esters; their salts
Indinavir; its salts
Indomethacin; its salts
Indoprofen; its salts
Indoramin; its salts
Infliximab
Inosine
Inosine pranobex
Interferons
Ipilimumab
Iprindole; its salts
Irbesartan; its salts
Irinotecan; its salts
Isoaminile; its salts
Isoetharine; its salts
Isoniazid; its salts; its derivatives; their salts; any compound with any substance falling within this item

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Isoprenaline; its salts

Isopyrin; its salts
Isotretinoin
Isoxicam; its salts
Isradipine
Itraconazole; its salts
Ivabradine; its salts
Ketamine; its salts
Ketanserin; its salts
Ketoconazole, except when contained in preparations for external application only
Ketophenylbutazone
Ketoprofen; its salts
Ketorolac; its salts; its esters
Labetalol; its salts
Lacidipine; its salts
Lacosamide; its salts
Lamivudine; its salts
Lamotrigine; its salts
Lanreotide; its salts
Lansoprazole
Lanthanum carbonate
Lapatinib; its salts
Laronidase
Laropiprant; its salts
Ledipasvir; its salts
Leflunomide; its salts
Lenalidomide; its salts
Lepirudin; its salts
Lercanidipine; its salts
Letrozole
Leuprorelin; its salts
Levallorphan; its salts
Levetiracetam; its salts
Levosimendan; its salts
Lidoflazine
Lignocaine; its salts in mixture with tetracaine or in mixture with the salts of tetracaine
Linaclotide; its salts
Linagliptin; its salts
Linezolid; its salts
Liraglutide
Lisinopril; its salts
Lithium carbonate
Lithium sulphate
Lixisenatide
Lomefloxacin; its salts; its esters
Lomustine
Lonazolac; its salts
Lopinavir; its salts
Loracarbef; its salts
Lorcainide; its salts
Losartan; its salts
Lovastatin
Loxapine; its salts
Lumefantrine; its salts
Lysuride; its salts

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Mangafodipir; its salts

Mannomustine; its salts
Maprotiline; its salts
Maraviroc; its salts
Marbofloxacin; its salts
Mazindol
Mebutamate
Mecamylamine; its salts
Meclofenamic acid; its salts
Meclofenoxate; its salts
Medigoxin
Mefenamic acid; its salts; its esters; their salts
Mefloquine; its salts
Mefruside
Melagatran; its salts; its derivatives; their salts
Melatonin; its salts; when contained in pharmaceutical products intended to be used for the treatment of insomnia
Melitracen; its salts
Meloxicam; its salts
Memantine; its salts
Mephenesin; its esters; their salts
Mephenoxalone
Mepirizole; its salts
Mepivacaine; its salts
Meprobamate
Mercaptopurine; its salts; its derivatives; their salts
Meropenem; it salts
Mertiatide; its salts; its esters; their salts
Mesalazine; its salts
Mescaline; its salts; other derivatives of phenethylamine formed by substitution in the aromatic ring; their salts
Mesocarb; its salts
Metaflumizone; its salts
Metaraminol; its salts
Metaxalone
Metergoline
Metformin; its salts
Methaqualone; its salts
Methimazole; its salts
Methixene; its salts
Methocarbamol
Methoxsalen
Methoxyphenamine and its salts when contained in aerosol dispensers
Methylaminoheptane and its salts when contained in aerosol dispensers
Methyldopa; its esters; their salts
Methylnaltrexone; its salts
Methylpentynol; its derivatives
alpha-Methylphenethylamine; beta-methylphenethylamine; alpha-ethylphene-thylamine; beta-ethylphenethylamine;
their optical isomers; any synthetic compound structurally derived from any of those substances by substitution in
the aliphatic part or by ring closure therein (or by both such substitution and such closure) or by substitution in the
aromatic ring (with or without substitution at the nitrogen atom), except hydroxyamphetamine, methoxy-phenamine,
phenylpropanolamine, pholedrine and N-substituted derivatives of ephedrine; any salt of any substance falling
within this item
Methylphenidate; its salts
Methyprylone
Metipranolol; its salts
Metoclopramide; its salts

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Metolazone
Metoprolol; its salts
Metyrapone; its salts
Mexiletine; its salts
Mianserin; its salts
Mibefradil; its salts
Micafungin; its salts; its esters
Midodrine; its salts
Mifepristone; its salts; its esters; their salts
Miglitol; its salts
Milnacipran; its salts
Milrinone; its salts
Minoxidil, except when contained in preparations intended for external application only and the preparations contain
not more than 5% of Minoxidil
Mirabegron; its salts; its esters; their salts
Mirtazapine; its salts
Mitobronitol
Mitopodozide; its salts
Mitotane
Mitoxantrone; its salts
Mivacurium; its salts
Mizolastine; its salts
Moclobemide; its salts
Moexipril; its salts
Mofebutazone; its salts
Molgramostim
Molindone; its salts
Montelukast; its salts
Moracizine; its salts
Moroxydine; its salts
Moxifloxacin; its salts
Moxonidine; its salts
Muromonab-CD3
Mustine and any other N-substituted derivative of di-(2-chloroethyl) amine; their salts
Muzolimine
Mycophenolic acid; its salts; its esters
Nabumetone
Nadolol; its salts
Nadroparin; its salts
Nafarelin; its salts
Naftidrofuryl; its salts
Nalbuphine; its salts
Nalidixic acid
Nalmefene; its salts
Nalorphine; its salts
Naloxone; its salts
Naltrexone; its salts
alpha-Naphthylacetic acid; its salts
Naproxen; its salts
Naratriptan; its salts
Natalizumab
Nateglinide; its salts; its esters
Nebivolol; its salts
Nefazodone; its salts
Nefopam; its salts

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Nelfinavir; its salts

Neostigmine; its salts
Nepafenac; its salts
Nesiritide
Nevirapine; its salts
Nicergoline
Nicocodine; its salts
Nicotinic acid and its salts when contained in pharmaceutical products the recommended daily dose of which contains
more than 200 mg of nicotinic acid
Nifedipine
Nifenazone
Niflumic acid; its salts
Nilotinib; its salts
Nilvadipine
Nimesulide; its salts
Nimodipine
Nisoldipine
Nitrendipine
Nitromethaqualone; its salts
Nomifensine; its salts
Noramidopyrine methanesulphonate; its salts
Norcodeine; its salts; its esters and ethers; their salts
Norfloxacin; its salts; its esters
Nortriptyline; its salts
Obinutuzumab; its antibody drug conjugates
Ocriplasmin
Octreotide; its salts
Ofloxacin; its salts; its esters
Olanzapine; its salts
Olmesartan; its salts; its esters; their salts
Olodaterol; its salts
Olsalazine; its salts
Omalizumab
Ombitasvir; its salts
Ondansetron; its salts
Opipramol; its salts; its derivatives; their salts
Orciprenaline and its salts when contained in aerosol dispensers
Orgotein
Orlistat; its salts; except when contained in a pharmaceutical product of which the recommended dose is a quantity of
the product that contains not more than 60 mg of orlistat or its salts, taken 3 times a day
Orphenadrine; its salts
Oseltamivir; its salts
Oteracil; its salts
Ouabain
Oxaliplatin; its salts
Oxanamide
Oxcarbazepine; its salts
Oxprenolol; its salts
Oxyfedrine; its salts
Oxypertine
Oxyphenbutazone
Oxytocins
Paclitaxel
Paliperidone; its salts
Palivizumab

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Palonosetron; its salts

Pamidronate; its salts
Pancuronium; its salts
Panitumumab
Pantethine; its salts
Pantoprazole; its salts
Paraldehyde
Paramethadione
Parecoxib; its salts
Pargyline; its salts
Paricalcitol; its salts; its esters; their salts
Paritaprevir; its salts
Paroxetine; its salts
Pasireotide; its salts
Pazopanib; its salts
Pefloxacin; its salts; its esters
Pegaptanib; its salts
Pegfilgrastim
Pegvisomant; its salts
Pemetrexed; its salts; its esters; their salts
Pemirolast; its salts
Pemoline; its salts
Pempidine; its salts
Penbutolol; its salts
Penciclovir; its salts
Penicillamine; its salts
Pentamidine; its salts
Pentazocine; its salts
Pentolinium; its salts
Perampanel
Pergolide; its salts
Perindoprilat; its salts; its esters; their salts
Pertuzumab
Phenacemide
Phenacetin
Phenaglycodol
Phenbutrazate
Phencyclidine; its salts
Phenetidylphenacetin
Phenformin; its salts
Phenindione
Phenothiazine; its salts; its derivatives (except dimethoxanate and promethazine); their salts (except salts of
dimethoxanate and promethazine); any compound with any substance falling within this item
Phenoxybenzamine; its salts
Phenprenazone
Phenprobamate
Phentolamine; its salts
Phenylbutazone; its salts
2-Phenylcinchoninic acid; 2-salicylcinchoninic acid; their salts; their esters
5-Phenylhydantoin; its alkyl and aryl derivatives; their salts
Picrotoxin
Pimecrolimus
Pioglitazone; its salts
Pipecuronium; its salts
Pipemidic acid

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Pipobroman
Piromidic acid; its salts
Piroxicam, except when contained in preparations for external application only
Pirprofen; its salts
Pituitary gland, the active principles of, other than corticotrophins, oxytocins and vasopressins, except when contained
in inhalants or in preparations intended for external application only
Pizotifen; its salts
Plerixafor; its salts
Polymethylenebistrimethylammonium salts
Pomalidomide; its salts
Poractant alfa
Posaconazole; its salts; its esters; their salts
Pralidoxime; its salts
Pramipexole; its salts
Prasugrel; its salt
Pravastatin; its salts; its esters
Prazosin; its salts
Pregabalin; its salts
Pridinol; its salts
Primaquine; its salts
Primidone
Prindolol; its salts
Probucol
Procainamide; its salts
Procarbazine; its salts
Procaterol and its salts when contained in aerosol dispensers
Proglumetacin; its salts
Proguanil; its salts
Promoxolane
Propafenone; its salts
Propanidid
Propiverine; its salts
Propofol
Propoxur; its salts
Propranolol; its salts; its derivatives; their salts
Propylhexedrine and its salts, except when contained in inhalers
Propylthiouracil; its salts
Proquazone
Prostaglandins, the following and their derivativesAlprostadil
Bimatoprost
Dinoprost
Dinoprostone
Latanoprost
Misoprostol
Travoprost
Unoprostone
their salts; their esters
Prothionamide
Prothipendyl; its salts
Protirelin; its salts
Protriptyline; its salts; its derivatives; their salts
Prucalopride; its salts
Prulifloxacin; its salts; its esters; their salts
Pyrazinamide

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Pyricarbate (Pyridinolcarbamate)
Pyridostigmine; its salts
Pyrimethamine
Pyrithyldione
Quetiapine; its salts
Quinagolide; its salts
Quinapril; its salts
Quinethazone
Quinidine; its salts
Quinine; its salts; its derivatives; their salts; except in preparations containing less than 10% of quinine, its salts, its
derivatives or their salts
Rabeprazole; its salts
Racecadotril; its salts
Ractopamine; its salts
Radium-223; its salts; when contained in pharmaceutical products
Raloxifene; its salts
Raltegravir; its salts
Raltitrexed; its salts
Ramipril; its salts
Ranibizumab
Ranolazine; its salts
Rasagiline; its salts
Rasburicase; its salts
Reboxetine; its salts
Recombinant human erythropoietin
Regorafenib; its salts
Remifentanil; its salts
Remoxipride; its salts
Repaglinide; its salts; its esters
Reproterol and its salts when contained in aerosol dispensers
Rescinnamine
Reteplase
Retigabine; its salts
Reviparin; its salts
Ribavirin; its salts
Rilmenidine; its salts
Rilpivirine; its salts
Riluzole; its salts
Rimiterol and its salts when contained in aerosol dispensers
Rimonabant; its salts
Riociguat; its salts
Risedronic acid; its salts
Risperidone
Ritodrine; its salts
Ritonavir; its salts
Rituximab
Rivaroxaban; its salts
Rivastigmine; its salts
Rizatriptan; its salts
Rocuronium; its salts
Rofecoxib; its salts
Roflumilast; its salts
Romiplostim
Ropinirole; its salts
Ropivacaine; its salts

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Rosiglitazone; its salts

Rosoxacin; its salts
Rosuvastatin; its salts
Rotigotine; its salts
Rufinamide; its salts
Ruxolitinib; its salts
Salbutamol and its salts, except when contained in aerosol dispensers
Salmeterol and its salts when contained in aerosol dispensers
Saquinavir; its salts
Saxagliptin; its salts
Sermorelin; its salts
Sertindole; its salts
Sertraline; its salts
Sevelamer; its salts
Sibutramine; its salts; any compound containing the chemical structure of 1-[1-(4-Chlorophenyl)cyclobutyl]-3methylbutan-1-amine substituted to any degree or without substitution; its salts
Sildenafil; its salts; any compound containing the chemical structure of-(2-ethoxyphenyl)-1-methyl-3-propyl1Hpyrazolo[4,3-d]pyrimidin-7(6H)-one substituted to any degree or without substitution; its salts
Simvastatin
Sirolimus; its salts
Sitagliptin; its salts
Sodium aurothiomalate
Sodium nitroprusside
Sofosbuvir; its salts
Solifenacin; its salts; its esters; their salts
Somatostatin
Sorafenib; its salts
Sotalol; its salts
Sparfloxacin; its salts; its esters
Sparteine; its salts
Spinosad
Spironolactone
Stavudine; its salts
Streptokinase
Strontium ranelate
Strophanthus, glycosides of
Styramate
Sulindac
Sulphinpyrazone
Sulphonal; alkyl sulphonals
Sulpiride
Sultopride
Sumatriptan; its salts
Sunitinib; its salts
Suprarenal gland, the active principles of, except adrenaline and noradrenaline (other than when contained in aerosol
dispensers); their salts; except salts of adrenaline (other than when contained in aerosol dispensers); their
derivatives; their salts; except hydrocortisone and its salts when contained in preparations intended for external
application only at not more than 1%; except beclomethasone and its salts when contained in aerosol dispensers and
except clobetasone butyrate when contained in preparations intended for external application only at not more than
0.05%
Sutoprofen; its salts
Suxamethonium; its salts
Syrosingopine
Tacrine; its salts
Tacrolimus

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Tadalafil; its salts; any compound containing the chemical structure of 6-(Benzo[1,3]dioxol-5-yl)-2,3,6,7,12,12ahexahydropyrazino[1,2:1,6]pyrido[3,4-b]indole-1,4-dione substituted to any degree or without substitution; its
salts
Tafluprost
Tamoxifen; its salts
Tapentadol; its salts
Tazarotene; its salts
Tegaserod; its salts
Telbivudine; its salts
Telmisartan; its salts
Temozolomide; its salts
Temsirolimus; its salts; its esters
Tenecteplase; its salts
Teniposide
Tenofovir; its salts; its esters; their salts
Tenoxicam
Terazosin; its salts
Terbinafine; its satls; except when contained in preparations for external application only
Terbutaline and its salts when contained in aerosol dispensers
Teriflunomide; its salts
Teriparatide; its salts
Terodiline; its salts
Tertatolol; its salts
Tetrabenazine; its salts
Tetracaine (being an amino alcohol esterified with a derivative of benzoic acid); its salts in mixture with lignocaine or
in mixture with the salts of lignocaine
Tetracosactide; its salts
Thalidomide; its salts
Theofibrate
Thiacetazone
Thiocarlide; its salts
Thioctic acid; its salts; its derivatives; when contained in pharmaceutical products
Thiotepa
Thymosin alpha 1
Thyroid gland, the active principles of; their salts
Thyrotropin alfa
Tiagabine; its salts; its esters; their salts
Tianeptine; its salts; its esters; their salts
Tiapride; its salts
Ticagrelor; its salts; its esters; their salts
Ticlopidine; its salts
Tiletamine; its salts
Tilidate; its salts
Tiludronic acid; its salts
Timolol; its salts
Tinoridine; its salts
Tinzaparin; its salts
Tiotropium; its salts
Tiratricol; its salts
Tirofiban; its salts
Tizanidine; its salts
Tocainide; its salts
Tocilizumab
Todralazine; its salts
Tofacitinib; its salts

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Tofenacin; its salts

Tolazamide
Tolbutamide
Tolcapone; its salts
Tolfenamic acid; its salts
Tolmetin; its salts
Tolperisone; its salts
Tolterodine; its salts
Tolvaptan
para-Tolylmethylcarbinol nicotinic acid ester
Topiramate; its salts
Topotecan; its salts
Torasemide
Trabectedin; its salts; its esters
Tramadol; its salts
Trandolapril; its salts
Tranexamic acid, except when contained in toothpaste at 0.05% by weight
Tranylcypromine; its salts
Trastuzumab; its antibody drug conjugates
Trazodone; its salts
Tretamine; its salts
Tretinoin
Triamterene; its salts
Triaziquone
Tribromoethyl alcohol
2,2,2-Trichloroethyl alcohol, esters of; their salts
Trifluridine; its salts
Trilostane
Trimetaphan; its salts
Trimetazidine; its salts
Trimethadione
Trimethoprim
Trimetozine
Trimetrexate; its salts
Trimipramine; its salts
Trioxsalen
Triptorelin; its salts
Tromantadine; its salts; except when contained in pharmaceutical products labelled for the treatment of cold sores
only
Tropisetron; its salts
Trovafloxacin; its salts; its derivatives; their salts
Tulobuterol and its salts when contained in aerosol dispensers
Tybamate
Umeclidinium; its salts
Urapidil; its salts
Urethane
Urokinase
Ustekinumab
Valaciclovir; its salts
Valdecoxib; its salts
Valganciclovir; its salts
Valnoctamide
Valproic acid; its salts; its esters
Valsartan; its salts
Vandetanib; its salts

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Vardenafil; its salts; any compound containing the chemical structure of 2-(2-ethoxyphenyl)-5-methyl-7propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one substituted to any degree or without substitution; its salts
Varenicline; its salts
Vasopressins
Vecuronium; its salts
Vedolizumab
Vemurafenib; its salts
Venlafaxine; its salts
Veralipride; its salts
Verapamil; its salts
Vernakalant; its salts
Verteporfin; its salts
Vidarabine; its salts
Vigabatrin
Vilanterol; its salts
Vildagliptin; its salts
Viloxazine; its salts
Vindesine; its salts
Vinorelbine; its salts
Vismodegib; its salts
Vitamin A and its esters when contained in pharmaceutical products the recommended daily dose of which contains
not less than 10000 international units of vitamin A
Voriconazole; its salts
Vortioxetine; its salts
Warfarin; its salts
Xamoterol; its salts
Xylazine; its salts
Zafirlukast
Zalcitabine; its salts
Zaleplon; its salts
Zanamivir; its salts
Zidovudine
Zimelidine; its salts
Zipeprol; its salts
Ziprasidone; its salts
Zofenopril; its salts
Zolazepam; its salts
Zoledronic acid; its salts
Zolmitriptan; its salts
Zolpidem; its salts
Zomepirac; its salts
Zopiclone
Zoxazolamine; its salts
(L.N. 137 of 1978; L.N. 369 of 1980; L.N. 415 of 1984; L.N. 129 of 1986; L.N. 130 of 1987; L.N. 197 of 1989;
L.N. 128 of 1990; L.N. 262 of 1995; L.N. 130 of 1998; L.N. 22 of 1999; L.N. 202 of 1999; L.N. 30 of 2000;
L.N. 138 of 2000; L.N. 235 of 2000; L.N. 296 of 2000; L.N. 51 of 2001; L.N. 143 of 2001; L.N. 173 of 2001;
L.N. 287 of 2001; L.N. 56 of 2002; L.N. 112 of 2002; L.N. 132 of 2002; L.N. 170 of 2002; L.N. 237 of 2002;
L.N. 73 of 2003; L.N. 179 of 2003; L.N. 181 of 2003; L.N. 273 of 2003; L.N. 276 of 2003; L.N. 74 of 2004;
L.N. 135 of 2004; L.N. 191 of 2004; L.N. 11 of 2005; L.N. 72 of 2005; L.N. 114 of 2005; L.N. 212 of 2005;
L.N. 25 of 2006; L.N. 122 of 2006; L.N. 178 of 2006; L.N. 223 of 2006; L.N. 277 of 2006; L.N. 41 of 2007;
L.N. 98 of 2007; L.N. 143 of 2007; L.N. 208 of 2007; L.N. 239 of 2007; L.N. 61 of 2008; L.N. 113 of 2008;
L.N. 197 of 2008; L.N. 234 of 2008; L.N. 282 of 2008; L.N. 90 of 2009; L.N. 147 of 2009; L.N. 199 of 2009;
L.N. 258 of 2009; L.N. 11 of 2010; L.N. 32 of 2010; L.N. 81 of 2010; L.N. 104 of 2010; L.N. 140 of 2010; L.N.
23 of 2011; L.N. 127 of 2011; L.N. 33 of 2012; L.N. 124 of 2012; L.N. 179 of 2012; L.N. 19 of 2013; L.N. 94
of 2013; L.N. 98 of 2013; L.N. 125 of 2013; L.N. 158 of 2013; L.N. 195 of 2013; L.N. 39 of 2014; L.N. 134 of

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2014; 2 of 2015 s. 67; L.N. 34 of 2015; L.N. 67 of 2015; L.N. 100 of 2015; L.N. 193 of 2015)
DIVISION B
(L.N. 41 of 2007)
Dinitronaphthols; dinitrophenols; dinitrothymols
Hexachlorophane; preparations containing more than 0.1% for human or animal use in aerosol containers;
preparations in the form of a cake, tablet or bar of soap for human use containing more than 2%; preparations in the
form of soaps or shampoos for animal use containing more than 2%; medicinal preparations for human or animal
use (except those for oral administration to sheep or cattle for liver fluke disease) containing more than 0.75%.
(L.N. 262 of 1995; L.N. 41 of 2007)
Schedule:

STATEMENT OF PARTICULARS AS TO
PROPORTION OF POISON IN CERTAIN CASES
PERMITTED BY REGULATION 14(a)

L.N. 41 of 2007

09/03/2007

[regulation 14]
DIVISION A
Name of Poison

Particulars

Alkaloids
Aconite, alkaloids of
The proportion of any one alkaloid of aconite that the preparation
would be calculated to contain on the assumption that all the
alkaloids of aconite in the preparation were that alkaloid.
Belladonna, alkaloids of
Calabar bean, alkaloids of
Coca, alkaloids of
Colchicum, alkaloids of
Ephedra, alkaloids of
Ergot, alkaloids of
Gelsemium, alkaloids of
Lobelia, alkaloids of
Pilocarpus, alkaloids of
Pomegranate, alkaloids of
Quebracho, alkaloids of,
other than the alkaloids of red
quebracho
Sabadilla, alkaloids of Stavesacre,
alkaloids of
Veratrum, alkaloids of
Yohimba, alkaloids of

Antimonial poisons

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The same as above, with the substitution for the reference to

aconite of a reference to balladonna, calabar bean or such other
of the said poisons as the case may require.

The proportion of antimony trioxide (Sb2O3) or antimony

pentoxide (Sb2O5) that the preparation would be calculated to
contain on the assumption that the antimony (Sb) in the poison
had been wholly converted into antimony trioxide or antimony
pentoxide as the case may be.

77

Arsenical poisons

The proportion of arsenic trioxide (As2O3) or arsenic pentoxide

(As2O5) that the preparation would be calculated to contain on
the assumption that the arsenic (As) in the poison had been
wholly converted into arsenic trioxide or arsenic pentoxide as
the case may be.
The number of units of activity as defined in the British
Pharmacopoeia contained in a specified quantity of the
preparation.

Digitalis, glycosides of; other active

principles of digitalis
Hydrocyanic acid ; cyanides other than
ferrocyanides and ferricyanides
Insulin

Lead, compounds of, with acids from

fixed oils

The proportion of hydrocyanic acid (HCN) that the preparation

would be calculated to contain on the assumption that the
cyanides in the poison had been wholly converted into
hydrocyanic acid.
The number of units of activity as defined in the British
Pharmacopoeia contained in a specified quantity of the
preparation.
The proportion of lead oxide (PbO) that the preparation would be
calculated to contain on the assumption that the lead in the
poison had been wholly converted into lead oxide.
The proportion of organically-combined mercury (Hg) contained
in the preparation.

Mercury, organic compounds of

The proportion of strychnine contained in the preparation.

The proportion of morphine contained in the preparation.

Nux Vomica
The proportion of phenols (added together) contained in the
preparation.
Opium
Phenols
Compounds of a phenol with a metal

Pituitary gland, the active principles of

The proportion of phenols (added together) that the preparation

would be calculated to contain on the assumption that the
compounds of phenols with a metal had been wholly converted
into the corresponding phenols.
Either(a) The number of units of activity as defined in the British
Pharmacopoeia contained in a specified quantity of the
preparation; or
(b) the proportion of pituitary gland, or of anterior or of
posterior lobe of the gland, as the case may be,
contained in the preparation; or
(c) the amount of pituitary gland, or of anterior or of
posterior lobe of the gland, as the case may be, from
which a specified quantity of the preparation was
obtained, together with an indication whether the
amount relates to fresh or to dried gland substance.
The amount of Standard Tincture of Strophanthus as defined in
the British Pharmacopoeia 1948 which possesses the same
activity as a specified quantity of the preparation when assayed
by the method described in the said Pharmacopoeia.

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Strophanthus, glycosides of

Suprarenal gland, the active principles

of; their salts; their derivatives;
their salts

Either(a) the proportion of Suprarenal of the cortex or of the

medulla of the gland, as the case may be, contained in
the preparation; or
(b) the amount of Suprarenal gland, or of the cortex or of
the medulla of the gland, as the case may be, from
which a specified quantity of the preparation was
obtained, together with an indication whether the
amount relates to fresh or to dried gland substance.
Either(a) the proportion of thyroid gland contained in the
preparation; or
(b) the amount of thyroid gland from which a specified
quantity of the preparation was obtained together with
an indication whether the amount relates to fresh or to
dried gland.

Thyroid gland, the active principles of;

their salts
(L.N. 41 of 2007)
DIVISION B
Barium, salts of

The proportion of one particular barium salt which the preparation

would be calculated to contain on the assumption that the
barium (Ba) in the preparation had been wholly converted into
that salt.

Potassium hydroxide

The proportion of potassium monoxide (K2O) which the

preparation would be calculated to contain on the assumption
that the potassium hydroxide in the preparation had been
wholly converted into potassium monoxide.

Sodium hydroxide

The proportion of sodium monoxide (Na2O) which the preparation

would be calculated to contain on the assumption that the
sodium hydroxide in the preparation had been wholly converted
into sodium monoxide.
(L.N. 41 of 2007)

Schedule:

L.N. 66 of 2015
INDICATION OF STATEMENT PRESCRIBED BY
REGULATION 15 FOR THE PURPOSES OF SECTION
27(c) OF THE ORDINANCE

20/03/2015

[regulation 15(2)]
1.

To be labelled with the words "Caution. It is dangerous to take this preparation except under medical
supervision." Medicines made up ready for the internal treatment of human ailments and containing insulin

2.

To be labelled with the words "Caution. It is dangerous to exceed the stated dose."

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79

Medicines (other than medicines containing insulin and medicines mentioned in paragraph 8 of this
Schedule) made up ready for the internal treatment of human ailments except in the case of a substance
included in the First Schedule
3.

To be labelled with the words "Poison. For animal treatment only." Medicines made up ready for the treatment of animals

4.

To be labelled with the words "Caution. This preparation may cause serious inflammation of the skin in certain
persons and should be used only in accordance with expert advice."
Preparations for the dyeing of hair containing phenylene diamines, toluene diamines or other alkylatedbenezene diamines or their salts

5.

To be labelled with the words "Caution. This substance is caustic." Potassium hydroxide, sodium hydroxide, and articles containing either of those substances

6.

To be labelled with the words "Caution. This substance is poisonous. The inhalation of its vapour, mist, spray or
dust may have harmful consequences. It may also be dangerous to let it contact the skin or clothing."

Diethyl para-nitrophenyl phosphate

Organic compounds of mercury in aerosols (L.N. 195 of 1977; L.N. 262 of 1995)
7.

To be labelled with the words "Caution. This preparation should be administered only under medical
supervision. The vapour is dangerous." Medicines made up ready for the internal or external treatment of human ailments and containing dyflos

8.

To be labelled with the words "Caution. This may cause drowsiness. If affected, do not drive or operate
machinery." Medicines made up ready for the internal treatment of human ailments containing any of the antihistamine
substances (except Astemizole, Bilastine, Cetirizine, Desloratadine, Fexofenadine, Loratadine and
Terfenadine), their salts or their compounds with any other substance (L.N. 262 of 1995; L.N. 202 of
1999; L.N. 132 of 2002, L.N. 66 of 2015)

9.

To be labelled with the words "Caution. Not to be taken internally." Preparations for external use containing mercuric ammonium chlorides

10.

(a) To be labelled with the words "Not to be used for babies" or "This preparation should
not be administered, except on medical advice, to a child under 2 years of age."
Hexachlorophane

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(b) To be labelled with the words "Not to be used for whole body bathing except on medical advice."
Soap for human use containing 2% or more of hexachlorophane
(c) To be labelled with the words "For animal treatment only." Medicine containing hexachlorophane for the treatment of animal
(d) To be labelled with the words "Not for use for lactating cattle." Medicine containing hexachlorophane for oral administration for the prevention or treatment of liver
fluke disease in cattle
(e) To be labelled with the words "Protective clothing must be worn by the operator when this product is being
administered." Medicine containing hexachlorophane for oral administration for the prevention or treatment of liver
fluke disease in sheep or cattle
11.

(Repealed L.N. 262 of 1995)

Schedule:

POISONS EXEMPTED BY REGULATION 4 FROM

LABELLING PROVISIONS WHEN SOLD OR
SUPPLIED IN CERTAIN CIRCUMSTANCES

L.N. 41 of 2007

09/03/2007

[regulation 4(2)]
DIVISION A
Antimony, chlorides of; oxides of; sulphides of; antimonates; antimonites
Chloroform
Glyceryl trinitrate
Lead acetates; compounds of lead with acids from fixed oils
Mercuric chloride; mercuric iodide; organic compounds of mercury
Mercury, nitrates of; oxides of
Oxalic acid; metallic oxalates
Phenols; compounds of phenol with a metal
Picric acid
(L.N. 41 of 2007)
DIVISION B
Ammonia
Alkali fluorides

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Dinitronaphthols; dinitrophenols; dinitrothymols

Formaldehyde
Formic acid
Hydrochloric acid
Hydrofluoric acid; sodium silicofluoride
Nitric acid
Nitrobenzene
meta-Nitrophenol; ortho-nitrophenol; para-nitrophenol
Phosphorus, yellow
Potassium hydroxide
Sodium hydroxide
Sulphuric acid
(L.N. 262 of 1995; L.N. 41 of 2007)
Schedule:

POISONS REQUIRED BY REGULATION 21 TO BE

SPECIALLY LABELLED FOR TRANSPORT

L.N. 41 of 2007

09/03/2007
[regulation 21]

DIVISION A
Arsenical poisons
Diethyl para-nitrophenyl phosphate
Hydrocyanic acid; cyanides, other than ferrocyanides and ferricyanides, except preparations containing less than the
equivalent of 0.1%, weight in weight, of hydrocyanic acid (HCN)
Nicotine
Strychnine; its salts
Thallium, salts of
(L.N. 195 of 1977; L.N. 41 of 2007)
DIVISION B
Barium, salts of, except barium sulphate
(L.N. 137 of 1978; L.N. 262 of 1995; L.N. 41 of 2007)

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Schedule:

L.N. 30 of 2015

06/02/2015

FORMS 1-5
(Repealed 2 of 2015 s. 69)
FORM 5A
(Repealed 2 of 2015 s. 69)
FORMS 6-10
(Repealed 2 of 2015 s. 69)
FORM 11
(Spent)
___________
FORMS 12-16
(Repealed 2 of 2015 s. 69)
Form 17

[regulation 41]

Form of Logo Prescribed for Section 13A

(2 of 2015 s. 69)
Schedule:

FEES

L.N. 30 of 2015

06/02/2015

[regulations 24A, 26, 29, 30D, 30E,

36, 36B, 36D & 41]
(2 of 2015 s. 70)

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Item
1.
2.
3.
4.
5.
6.
7.
8.
9.
10.
10A.
10B.
11.
12.
13.
14.
15.
16.
17.
18.
19.
20.
21.
22.
Schedule:

Particular

Fee

$
Examination in each subject prescribed by the Board (L.N. 60 of 2001)
1110
Issue of a certificate of registration as a pharmacist (L.N. 60 of 2001)
790
Issue of a duplicate certificate of registration as a pharmacist
395
Registration of premises of an authorized seller of poisons
1000
Renewal of registration of premises of an authorized seller of poisons (2 of 2015 s.
1310
70)
Application for entry on the list of listed sellers of poisons
455
Retention on the list of listed sellers of poisons, each year
430
Any alteration to the register of premises or to the list of listed sellers
250
An annual wholesale dealer licence (2 of 2015 s. 70)
625
Annual licence for manufacturers
2680
Certificate of registration of an authorized person (2 of 2015 s. 70)
1420
Renewed certificate of registration of an authorized person (2 of 2015 s. 70)
1420
Application for registration of a product
1100
Certificate of registration of a product
1370
Renewal of a certificate of registration of a product
575
Free Sale Certificate of Pharmaceutical Product
180
Certificate of Pharmaceutical Product
140
Certificate and Interim Certificate for Manufacturer
2020
Annual practising certificate for a registered pharmacist (34 of 1995 s. 43; L.N. 60
520
of 2001)
Application for a clinical trial or medicinal test
1420
Certificate for clinical trial or medicinal test
1420
(Repealed 2 of 2015 s. 70)
Duplicate of any certificate
220
Issue of a certificate of good standing (L.N. 60 of 2001)
415
(L.N. 597 of 1994; L.N. 214 of 1997; L.N. 126 of 2006)
10

L.N. 193 of 2015 09/10/2015

Poisons List

[regulation 2A]
Poisons List
1.

Interpretation
(1) In the Poisons List, a reference to a substance includes
(a) that substance prepared either from natural sources or artificially; and
(b) that substance when contained as such in a preparation, solution, mixture or natural substance.
(2) In the Poisons List
derivative () means an organic compound of the following descriptions
(a) it is related to another organic compound (parent compound) because it has
(i) the same elemental ring, chain, nucleus or skeleton; and
(ii) similar pharmaceutical activity;
(b) it may have a molecular weight which may be the same as, or higher or lower (for example, after
formation of a derivative by the process commonly known as dehydrogenation) than that of the parent
compound; and
(c) its preparation may or may not require the presence of the parent compound.
(3) In the Poisons List
(a) substances listed in Divisions A are those whose uses are essentially medicinal; and
(b) substances listed in Divisions B are not normally used medicinally.

2.

Poisons List

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The Poisons List is set out in the Table.

Table
Part I
Division A
Abacavir; its salts
Abatacept
Abciximab
Abiraterone; its salts
Acamprosate; its salts
Acarbose; its salts
Acebutolol; its salts
Acemetacin; its salts
Acetanilide; alkyl acetanilides
Acetazolamide; its salts
Acetohexamide
Acetorphine; its salts; its esters and ethers; their salts
Acetylcarbromal
Acetyldihydrocodeine; its salts
Aciclovir; its salts
Acipimox; its salts
Acitretin; its salts; its esters
Adalimumab
Adapalene; its salts; its esters
Adefovir; its salts; its esters; their salts
Afatinib; its salts
Aflibercept
Agalsidase beta
Agomelatine; its salts
Alclofenac; its complexes
Alcuronium; its salts
Aldesleukin
Alefacept
Alemtuzumab
Alendronic acid; its salts
Alfuzosin; its salts
Alglucosidase alfa
Aliskiren; its salts; its esters; their salts
Alizapride; its salts
Alkaloids, the following; their quaternary compounds; any salt, simple or complex, of any substance falling
within the following
Aconite, alkaloids of
Atropine
Belladonna, alkaloids of
Brucine
Calabar bean, alkaloids of
Coca, alkaloids of
Cocaine
Codeine; its esters and ethers
Colchicum, alkaloids of; their salts
Coniine

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Cotarnine
Curare, alkaloids of; curare bases
Ecgonine; its esters and ethers
Emetine
Ephedra, alkaloids of
Ergot, alkaloids of
Galantamine
Gelsemium, alkaloids of
Homatropine
Hyoscine
Hyoscyamine
Lobelia, alkaloids of
Morphine; its esters and ethers
Nicotine (except when contained in (a) chewing gum or lozenges, intended to be used in nicotine
replacement therapy and containing not more than 4 mg of Nicotine per piece; or (b) patches for
external application, intended to be used in nicotine replacement therapy)
Nux Vomica, alkaloids of
Papaverine
Pilocarpus, alkaloids of
Pomegranate, alkaloids of
Quebracho, alkaloids of
Rauwolfia, alkaloids of; their derivatives
Sabadilla, alkaloids of
Stavesacre, alkaloids of
Strychnine
Thebaine
Veratrum, alkaloids of
Vinca, alkaloids of
Yohimba, alkaloids of
Allergen extract of Dermatophagoides pteronyssinus
Allopurinol
Allylisopropylacetylurea
Allylprodine; its salts
Almitrine; its salts
Alogliptin; its salts
Alphadolone; its esters
Alphaxalone
Alprenolol; its salts
Alteplase
Alufibrate
Amantadine; its salts
Ambrisentan; its salts; its esters; their salts
Amidopyrine; its salts
Amifostine; its salts
Amiloride; its salts
Amineptine; its salts
Amino-alcohols esterified with benzoic acid, phenylacetic acid, phenylpropionic acid, cinnamic acid or the
derivatives of these acids; their salts (except procaine when in a preparation containing any substance to
which the Antibiotics Ordinance (Cap 137) for the time being applies)
para-Aminobenzenesulphonamide; its salts; derivatives of para-aminobenzenesulphonamide having any of the
hydrogen atoms of the para-amino group or of the sulphonamide group substituted by another radical; their
salts
para-Aminobenzoic acid, esters of; their salts; except benzocaine when contained in condoms
Aminoglutethimide
5-Aminolevulinic acid; its salts; its derivatives; their salts

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Aminophylline; its salts

Aminopterin; its derivatives
Aminorex; its salts
para-Aminosalicylic acid; its salts; its derivatives; their salts; any compound with any substance falling within
this item
Amiodarone; its salts
Amisulpride; its salts
Amitriptyline; its salts
Amlodipine; its salts
Amrinone
Amsacrine; its salts
Amyl nitrite
Amylene hydrate
Anagrelide; its salts
Anastrozole; its salts
Androgenic, oestrogenic and progestational substances, the following
Benzoestrol
Derivatives of stilbene, dibenzyl or naphthalene with oestrogenic activity; their esters
Steroid compounds with androgenic or oestrogenic or progestational activity; their esters
Anidulafungin; its salts; its esters; their salts
Anileridine; its salts
Anistreplase
Antihistamine substances, the following; their salts; any compound with any substance falling within this item
Acrivastine
Antazoline
Astemizole
Azelastine
Bilastine
Bromodiphenhydramine
Buclizine
Chlorcyclizine
Cyclizine
Desloratadine
3-Di-n-butylaminomethyl-4,5,6-trihydroxyphthalide
Dimethothiazine
Diphenhydramine
Doxylamine
Ebastine
Fexofenadine
Isothipendyl
Ketotifen
Loratadine (except Loratadine; its salts; when contained in pharmaceutical products labelled for the
relief of the symptoms of allergic rhinitis only)
Mebhydrolin
Meclozine
Methdilazine
Phenindamine
Promethazine
Terfenadine
Thenalidine
Trimeprazine
Tripelennamine
Substances being tetra-substituted N derivatives of ethylene-diamine or propylenediamine
Antihistamine substances other than the above; their salts; any compounds with such substances; when
contained in preparations for parenteral use

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Antilymphocyte Immunoglobulins
Antimony, chlorides of; organic compounds of; antimonates; antimonites
Antisera, antitoxins, immunoglobulins and vaccines
(a) the following
Bacillus Calmette-Gurin (BCG)
Meningococcal vaccines
Normal immunoglobulins
Pneumococcal vaccines
Rotavirus vaccines
Snake venom antisera
Staphylococcal vaccines
Streptococcal vaccines;
(b) directed against the following diseases, viruses or organisms
Bordetella species
Botulism
Canine infectious disease
Cholera
Diphtheria
Feline calicivirus
Feline Chlamydia psittaci
Feline immunodeficiency virus
Feline leukemia virus
Feline panleukopenia virus
Feline rhinotracheitis virus
Haemophilus influenzae type b
Hepatitis A
Hepatitis B
Herpes simplex
Herpes zoster
Human papillomavirus
Influenza
Japanese encephalitis
Measles
Mumps
Pertussis
Plague
Poliomyelitis
Rabies
Rubella
Tetanus
Typhoid
Varicella
Yellow fever
Antithymocyte Immunoglobulin
Apixaban; its salts
Apomorphine; its salts; its quaternary compounds
Apraclonidine; its salts
Aprepitant; its salts
Aprindine; its salts
Aripiprazole
Arsenic trioxide when contained in pharmaceutical products
Arsenical substances, the following: halides of arsenic; organic compounds of arsenic; oxides of arsenic;
sulphides of arsenic; arsenates; arsenites; thioarsenates
Artemether; its salts

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Articaine; its salts

Asenapine; its salts; its isomers
Atazanavir; its salts
Atenolol; its salts
Atomoxetine; its salts
Atorvastatin; its salts
Atosiban; its salts
Atovaquone
Atracurium besylate
Auranofin
Axitinib; its salts
Azacitidine; its salts
Azacyclonol; its salts
Azapropazone
Azauridine; its derivatives
Azilsartan; its salts; its esters; their salts
Aziridine; its derivatives
Baclofen
Bambuterol; its salts
Barbituric acid; its salts; its derivatives; their salts; any compound with any substance falling within this item
Basiliximab; its salts
Becaplermin; its salts
Befunolol; its salts
Belimumab
Bemiparin; its salts
Benactyzine; its salts
Benazepril; its salts
Benoxaprofen; its salts
Benserazide; its salts
Benzbromarone
Benzethidine; its salts
Benzhexol; its salts
Benzoylmorphine; its salts
Benzquinamide
Benztropine and its homologues; their salts
Benzydamine; its salts
Benzylmorphine; its salts
Besifloxacin; its salts; its esters; their salts
Betaxolol; its salts
Bethanidine; its salts
Bevacizumab
Bezafibrate
Bezitramide; its salts
Bicalutamide; its salts
Bifonazole; its salts
Biperiden; its salts
Biphenylacetic acid; its salts; its esters
N-[4,4-Bis(para-fluorophenyl)butyl]piperidine,4-substituted derivatives of; their salts
Bisoprolol; its salts
Bitolterol; its salts
Blood products derived from human blood or manufactured by biotechnology, the following
Albumin
Antithrombins
Blood clotting factors
Fibrin

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Fibrinogen
Plasma protein fractions
Thrombin
Boceprevir; its salts
Bortezomib
Bosentan; its salts
Botulinum toxin complexes
Brentuximab vedotin
Bretylium tosylate
Brimonidine; its salts
Brinzolamide; its salts
Bromocriptine; its salts
Bromvaletone
Broncho-Vaxom
Brotizolam
Bucolome
Bufexamac
Buformin; its salts
Bumadizone; its salts
Bumetanide; its salts; its derivatives; their salts
Bupivacaine; its salts
Bupranolol; its salts
Buprenorphine; its salts
Bupropion; its salts
Buserelin; its salts
Buspirone; its salts
Busulphan; its salts
Butorphanol; its salts
Butylchloral hydrate
Cabazitaxel; its salts; its esters; their salts
Cabergoline; its salts
Calcipotriol; its salts
Canagliflozin; its salts
Canakinumab
Candesartan; its salts; its esters; their salts
Cannabinol and its tetrahydro derivatives; their 3-alkyl homologues; any ester or ether of any substance falling
within this item
Cannabis; the resin of cannabis; extracts of cannabis; tinctures of cannabis; cannabin tannate
Cantharidin; cantharidates
Capecitabine; its salts
Captodiamine; its salts
Captopril
Caramiphen; its salts
Carbachol
Carbamazepine
Carbidopa; its salts
Carbimazole; its salts
Carboplatin
Carbromal
Carbutamide
Carisoprodol
Carmustine
Carperidine; its salts
Carprofen; its salts
Carteolol; its salts

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Carvedilol; its salts

Caspofungin; its salts
Celecoxib; its salts
Celiprolol; its salts
Cerivastatin; its salts
Certolizumab pegol
Cetrorelix; its salts; its esters; their salts
Cetuximab
Chlofenamic acid; its salts
Chloral; its addition and its condensation products; any compound with any substance falling within this item
Chlordiazepoxide; its salts
Chlormethiazole; its salts
Chlormezanone
Chloroform
Chloroquine; its salts; its derivatives; their salts
Chlorothiazide and other derivatives of benzo-1,2,4- thiadiazine-7-sulphonamide 1,1-dioxide, whether
hydrogenated or not; their salts
Chlorphenoxamine; its salts
Chlorphentermine; its salts
Chlorpropamide; its salts
Chlorprothixene and other derivatives of 9-methylenethiaxanthen; their salts
Chlorthalidone and other derivatives of ortho-chlorobenzenesulphonamide
Chlorzoxazone
Chorionic Gonadotrophin
Chymopapain
Cicletanine; its salts
Cidofovir; its salts
Cilazapril; its salts
Cilostazol; its salts
Cinacalcet; its salts
Cinepazide; its salts
Ciprofibrate; its salts
Ciprofloxacin; its salts; its esters
Cisapride
Cisatracurium besylate
Cisplatin
Citalopram; its salts
Cladribine
Clioquinol
Clobazam
Clodronic acid; its salts; its esters
Clofarabine; its salts; its esters; their salts
Clofazimine; its salts
Clofibrate
Clomiphene; its salts
Clomipramine; its salts; its derivatives; their salts
Clonidine; its salts
Clonitazene; its salts
Clopidogrel; its salts
Clorexolone
Cloridarol
Clorprenaline; its salts
Clothiapine
Clotrimazole; its salts
Clozapine; its salts

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Cobicistat; its salts

Colaspase
Colfosceril; its salts
Collagen, purified
Contrast media, the following; their salts; any compound with any substance falling within this item; when
contained in preparations for parenteral use
Acetrizoic acid
Diatrizoic acid
Ferucarbotran
Gadobenic acid
Gadobutrol
Gadodiamide
Gadopentetic acid
Gadoteric acid
Iobitridol
Iocarmic acid
Iocetamic acid
Iodamide
Iodipamide
Iodised oil
Iodixanol
Iodoxamic acid
Ioglicic acid
Ioglycamic acid
Iohexol
Iomeprol
Iopamidol
Iopanoic acid
Iophendylate
Iopromide
Iothalamic acid
Iotrolan
Iotroxic acid
Ioversol
Ioxaglic acid
Ioxitalamic acid
Ipodic acid
Metrizamide
Propyliodone
Sulphur hexafluoride
Tyropanoic acid
Corifollitropin alfa
Corticorelin; its salts
Corticotrophins
Corynebacterium parvum
Creosote obtained from wood
Crizotinib; its salts
Croton, oil of
4-Cyano-2-dimethylamino-4,4-diphenylbutane; its salts
4-Cyano-1-methyl-4-phenylpiperidine; its salts
Cyclarbamate
Cyclobenzaprine; its salts
Cyclofenil
1-Cyclohexyl-3-para-toluenesulphonylurea (tolcyclamide)
Cyclosporin A

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Cycrimine; its salts

Cytarabine; its salts
Dabigatran etexilate; its salts
Dabrafenib; its salts
Dacarbazine
Daclizumab
Dalteparin; its salts
Dapagliflozin; its salts
Dapoxetine; its salts
Dapsone
Darbepoetin alfa
Darifenacin; its salts
Darunavir; its salts
Dasabuvir; its salts
Dasatinib; its salts
Deanol acetamidobenzoate
Debrisoquine; its salts
Decitabine; its salts
Deferasirox; its salts; its esters; their salts
Deferiprone; its salts
Degarelix; its salts
Dehydroemetine; its salts
Demecarium bromide
Denosumab
Desferrioxamine; its salts
Desipramine; its salts
Desomorphine; its salts; its esters and ethers; their salts
Desvenlafaxine; its salts
Dexketoprofen; its salts
Dexlansoprazole; its salts
Dexmedetomidine; its salts
Dexrazoxane; its salts
Diacerein; its salts; its esters
Diacetylnalorphine; its salts
Diampromide; its salts
Diazepam and other compounds containing the chemical structure of dihydro-1,4-benzodiazepine substituted to
any degree; their salts
Diazoxide
Diclofenac; its salts
Didanosine; its salts
Diethylaminoethylephedrine; its salts
Diethyl para-nitrophenyl phosphate
Difenoxin; its salts
Diflunisal
Digitalis, glycosides of; other active principles of digitalis
Dihydralazine; its salts
Dihydrocodeine; its salts; its esters and ethers; their salts
Dihydrocodeinone; its salts
Dihydrocodeinone O-carboxymethyloxime; its salts; its esters; their salts
Dihydrocodeinone enol acetate; its salts
Dihydroergotamine; its salts, simple or complex
Dihydroetorphine; its salts
Dihydromorphine; its salts; its esters and ethers; their salts
3-(3,4-Dihydroxyphenyl)alanine; its salts
Diltiazem; its salts

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Dimefline; its salts

Dimenoxadole; its salts
Dimepheptanol; its salts; its esters and ethers; their salts
Dioxaphetyl butyrate; its salts
Diperodon; its salts
Diphenoxylate; its salts
Dipipanone; its salts
Diprenorphine; its salts
Dipyridamole
Disopyramide; its salts
Distigmine; its salts
Disulfiram
Dithienylallylamines; dithienylalkylallylamines; their salts
Dobutamine; its salts
Docetaxel; its salts
Dolutegravir; its salts
Domperidone; its salts
Donepezil; its salts
Dopamine; its salts
Dornase alfa
Dorzolamide; its salts
Dothiepin; its salts
Doxapram; its salts
Doxazosin; its salts
Doxepin; its salts; its derivatives; their salts
Dronedarone; its salts
Droperidol
Drotrecogin alfa
Duloxetine; its salts
Dutasteride
Dyflos
Econazole; its salts
Ecothiopate iodide
Ectylurea
Eculizumab
Efalizumab
Efavirenz; its salts
Elaterin
Eletriptan; its salts
Elosulfase alfa
Eltrombopag; its salts; its esters; their salts
Elvitegravir; its salts
Embutramide
Empagliflozin; its salts
Emtricitabine; its salts
Emylcamate
Enalapril; its salts
Enalaprilat; its salts
Enfuvirtide
Enoxacin; its salts; its esters
Enoxaparin; its salts
Enoximone
Enrofloxacin; its salts; its esters
Entacapone; its salts
Entecavir; its salts; its esters; their salts

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Enzalutamide; its salts

Eplerenone
Epoetin beta
Eprosartan; its salts
Eptifibatide; its salts
Eribulin; its salts
Erlotinib; its salts
Erythrityl tetranitrate
Esmolol; its salts
Esomeprazole; its salts
Etafedrine; its salts
Etafenone; its salts
Etamivan; its salts
Etanercept
Ethacrynic acid; its salts
Ethambutol; its salts
Ethchlorvynol
Ethinamate
Ethionamide
Ethoglucid
Ethoheptazine; its salts
Ethosuximide; its salts
Ethylmorphine; its salts; its esters and ethers; their salts
Ethylnoradrenaline; its salts
Etidronic acid; its salts
Etilefrine; its salts
Etodolac
Etofibrate
Etomidate; its salts
Etonitazene; its salts
Etoposide; its esters
Etoricoxib; its salts
Etorphine; its salts; its esters and ethers; their salts
Etoxeridine; its salts
Etravirine
Etretinate
Etryptamine; its salts
Everolimus; its salts; its esters; their salts
Exemestane; its salts
Exenatide
Ezetimibe
Famciclovir; its salts
Fampridine; its salts
Febuxostat; its salts; its esters; their salts
Felodipine
Fenbufen
Fencamfamin; its salts
Fenclofenac; its salts
Fendiline; its salts
Fenfluramine; its salts
Fenofibrate
Fenoprofen; its salts
Fenoterol; its salts
Fenoxazoline; its salts
Fentanyl; its salts

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Fentiazac; its salts

Fenticonazole; its salts
Feprazone
Fesoterodine; its salts; its esters; their salts
Filgrastim
Finasteride
Fingolimod; its salts; its esters; their salts
Flavoxate; its salts
Flecainide; its salts
Fleroxacin; its salts; its esters
Fluanisone
Fluconazole; its salts
Flucytosine
Fludarabine; its salts
Flufenamic acid; its salts; its esters; their salts
Flumazenil
Flumethrin; its salts
Fluorouracil; its derivatives
Fluoxetine; its salts
Flupenthixol; its salts
Flurbiprofen
Fluspirilene
Flutamide
Fluvastatin
Fluvoxamine; its salts
Folinic acid; its salts
Fondaparinux; its salts
Formestane
Formoterol; its salts
Fosaprepitant; its salts
Foscarnet trisodium hexahydrate
Fosinopril; its salts
Fosphenytoin; its salts
Fotemustine; its salts
Frusemide
Fulvestrant
Furethidine; its salts
Gabapentin; its salts
Gadoxetic acid; its salts
Gallamine; its salts; its quaternary compounds
Gallopamil; its salts
Galsulfase
Ganciclovir; its salts
Ganirelix; its salts
Gatifloxacin; its salts; its esters
Gefitinib; its salts
Gemcitabine; its salts
Gemfibrozil
Gimeracil; its salts
Glibenclamide
Glibornuride
Gliclazide
Glimepiride; its salts
Glipizide
Gliquidone

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Glucagon; its salts

Glutethimide; its salts
Glyceryl trinitrate
Glycopyrronium; its salts
Glymidine
Golimumab
Gonadorelin; its salts
Goserelin; its salts
Granisetron; its salts
Grepafloxacin; its salts; its esters
Guanabenz; its salts
Guanethidine; its salts
Guanfacine; its salts
Guanidines, the following
Polymethylene diguanidines; di-para-anisyl-para-phenethylguanidine; their salts
Halofantrine; its salts
Halofuginone; its salts
Haloperidol and other 4-substituted derivatives of N-(3- para-fluorobenzoylpropyl) piperidine
Hexamethylmelamine
Hexapropymate
Hexobendine; its salts
Hydralazine; its salts
Hydrazines, the following and their alpha-methyl derivatives
Benzyl hydrazine
Phenethyl hydrazine
Phenoxyethyl hydrazine
their salts; their acyl derivatives; their salts
Hydrocyanic acid; cyanides, other than ferrocyanides and ferricyanides
Hydromorphinol; its salts; its esters and ethers; their salts
Hydromorphone; its salts; its esters and ethers; their salts
Hydroxycinchoninic acids; derivatives of; their salts; their esters
Hydroxy-N,N-dimethyltryptamines; their esters and ethers; any salt of any substance falling within this item
3-Hydroxy-N-methylmorphinan; its salts; its optical isomers; their salts
3-Hydroxymorphinan; its salts; its optical isomers; their salts; their esters and ethers; their salts
3-Hydroxy-N-phenacylmorphinan; its salts; its optical isomers; their salts; their esters and ethers; their salts
Hydroxypethidine; its salts; its esters and ethers; their salts
Hydroxyphenamate
Hydroxyurea
Hydroxyzine; its salts
Ibandronic acid; its salts
Ibritumomab tiuxetan
Ibrutinib; its salts
Ibuprofen; its salts
Idelalisib; its salts
Idursulfase
Ifosfamide
Iloprost; its salts
Imatinib; its salts
Imidapril; its salts
Imiglucerase
Imipramine; its salts
Imiquimod; its salts
Indacaterol; its salts; its esters; their salts
Indinavir; its salts
Indomethacin; its salts

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Indoprofen; its salts

Indoramin; its salts
Infliximab
Inosine
Inosine pranobex
Insulin
Interferons
Ipilimumab
Iprindole; its salts
Irbesartan; its salts
Irinotecan; its salts
Isoaminile; its salts
Isoconazole; its salts
Isoetharine; its salts
Isomethadone; its salts
Isoniazid; its salts; its derivatives; their salts; any compound with any substance falling within this item
Isoprenaline; its salts
Isopyrin; its salts
Isosorbide; its nitrates
Isotretinoin
Isoxicam; its salts
Isradipine
Itraconazole; its salts
Ivabradine; its salts
Ketamine; its salts
Ketanserin; its salts
Ketobemidone; its salts; its esters and ethers; their salts
Ketoconazole
Ketophenylbutazone
Ketoprofen; its salts
Ketorolac; its salts; its esters
Labetalol; its salts
Lacidipine; its salts
Lacosamide; its salts
Lamivudine; its salts
Lamotrigine; its salts
Lanreotide; its salts
Lansoprazole
Lanthanum carbonate
Lapatinib; its salts
Laronidase
Laropiprant; its salts
Laudexium; its salts
Lead acetates; compounds of lead with acids from fixed oils
Ledipasvir; its salts
Leflunomide; its salts
Lenalidomide; its salts
Lepirudin; its salts
Lercanidipine; its salts
Letrozole
Leuprorelin; its salts
Levallorphan; its salts
Levetiracetam; its salts
Levodropropizine; its salts
Levosimendan; its salts

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Lidoflazine
Lignocaine; its salts
Linaclotide; its salts
Linagliptin; its salts
Linezolid; its salts
Liraglutide
Lisinopril; its salts
Lithium carbonate
Lithium sulphate
Lixisenatide
Lodoxamide tromethamine
Lomefloxacin; its salts; its esters
Lomustine
Lonazolac; its salts
Lopinavir; its salts
Loracarbef; its salts
Lorcainide; its salts
Losartan; its salts
Lovastatin
Loxapine; its salts
Lumefantrine; its salts
Lysergamide; its salts, simple or complex; its quaternary compounds
Lysergic acid; its salts, simple or complex; its quaternary compounds
Lysergide; its salts, simple or complex; its quaternary compounds
Lysuride; its salts
Mangafodipir; its salts
Mannityl hexanitrate
Mannomustine; its salts
Maprotiline; its salts
Maraviroc; its salts
Marbofloxacin; its salts
Mazindol
Mebezonium iodide
Mebutamate
Mecamylamine; its salts
Meclofenamic acid; its salts
Meclofenoxate; its salts
Medigoxin
Mefenamic acid; its salts; its esters; their salts
Mefloquine; its salts
Mefruside
Melagatran; its salts; its derivatives; their salts
Melatonin; its salts; when contained in pharmaceutical products intended to be used for the treatment of
insomnia
Melitracen; its salts
Meloxicam; its salts
Memantine; its salts
Mephenesin; its esters; their salts
Mephenoxalone
Mepirizole; its salts
Mepivacaine; its salts
Meprobamate
alpha-Meprodine; its salts
beta-Meprodine; its salts
Mercaptopurine; its salts; its derivatives; their salts

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Mercury, nitrates of; organic compounds of; oxides of; mercuric ammonium chloride; mercuric chloride;
mercuric iodide; mercuric oxycyanide; mercuric thiocyanate; potassiomercuric iodides
Meropenem; its salts
Mertiatide; its salts; its esters; their salts
Mesalazine; its salts
Mescaline; its salts; other derivatives of phenethylamine formed by substitution in the aromatic ring; their salts
Mesocarb; its salts
Metaflumizone; its salts
Metaraminol; its salts
Metaxalone
Metazocine; its salts; its esters and ethers; their salts
Metergoline
Metformin; its salts
Methadone; its salts
Methadyl acetate; its salts
Methaqualone; its salts
Methimazole; its salts
Methixene; its salts
Methocarbamol
Methorphan; its salts; its optical isomers; their salts
Methoxsalen
Methoxyphenamine; its salts
Methylaminoheptane; its salts
Methyldesorphine; its salts; its esters and ethers; their salts
Methyldihydromorphine; its salts; its esters and ethers; their salts
Methyldopa; its esters; their salts
2-Methyl-3-morpholino-1,1-diphenylpropane carboxylic acid; its salts; its esters; their salts
Methylnaltrexone; its salts
Methylpentynol; its derivatives
alpha-Methylphenethylamine;
beta-methylphenethylamine;
alpha-ethylphenethylamine;
betaethylphenethylamine; their optical isomers; any synthetic compound structurally derived from any of those
substances by substitution in the aliphatic part or by ring closure therein (or by both such substitution and
such closure) or by substitution in the aromatic ring (with or without substitution at the nitrogen atom),
except hydroxyamphetamine, methoxyphenamine, pholedrine and N-substituted derivatives of ephedrine;
any salt of any substance falling within this item
Methylphenidate; its salts
1-Methyl-4-phenylpiperidine-4-carboxylic acid; its salts; its esters; their salts
Methyprylone
Metipranolol; its salts
Metoclopramide; its salts
Metolazone
Metopon; its salts; its esters and ethers; their salts
Metoprolol; its salts
Metronidazole; its salts
Metyrapone; its salts
Mexiletine; its salts
Mianserin; its salts
Mibefradil; its salts
Micafungin; its salts; its esters
Miconazole; its salts
Midodrine; its salts
Mifepristone; its salts; its esters; their salts
Miglitol; its salts
Milnacipran; its salts
Milrinone; its salts

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Minoxidil
Mirabegron; its salts; its esters; their salts
Mirtazapine; its salts
Mitobronitol
Mitopodozide; its salts
Mitotane
Mitoxantrone; its salts
Mivacurium; its salts
Mizolastine; its salts
Moclobemide; its salts
Moexipril; its salts
Mofebutazone; its salts
Molgramostim
Molindone; its salts
Montelukast; its salts
Moracizine; its salts
Moramide; its salts; its optical isomers; their salts
Moroxydine; its salts
Morpheridine; its salts
Moxifloxacin; its salts
Moxonidine; its salts
Muromonab-CD3
Mustine and any other N-substituted derivative of di-(2- chloroethyl)amine; their salts
Muzolimine
Mycophenolic acid; its salts; its esters
Myrophine; its salts
Myrtecaine; its salts
Nabumetone
Nadolol; its salts
Nadroparin; its salts
Nafarelin; its salts
Naftidrofuryl; its salts
Nalbuphine; its salts
Nalidixic acid
Nalmefene; its salts
Nalorphine; its salts
Naloxone; its salts
Naltrexone; its salts
alpha-Naphthylacetic acid; its salts
Naproxen; its salts
Naratriptan; its salts
Natalizumab
Nateglinide; its salts; its esters
Nebivolol; its salts
Nedocromil; its salts
Nefazodone; its salts
Nefopam; its salts
Nelfinavir; its salts
Neostigmine; its salts
Nepafenac; its salts
Nesiritide
Nevirapine; its salts
Nicergoline
Niclofolan
Nicocodine; its salts

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Nicotinic acid and its salts when contained in pharmaceutical products the recommended daily dose of which
contains more than 200 mg of nicotinic acid
Nifedipine
Nifenazone
Niflumic acid; its salts
Nilotinib; its salts
Nilvadipine
Nimesulide; its salts
Nimodipine
Nisoldipine
Nitrendipine
Nitromethaqualone; its salts
Nomifensine; its salts
Noracymethadol; its salts
Noramidopyrine methanesulphonate; its salts
Norcodeine; its salts; its esters and ethers; their salts
Norfloxacin; its salts; its esters
Normethadone; its salts
Normorphine; its salts; its esters and ethers; their salts
Norpipanone; its salts
Nortriptyline; its salts
Obinutuzumab; its antibody drug conjugates
Ocriplasmin
Octreotide; its salts
Ofloxacin; its salts; its esters
Olanzapine; its salts
Olmesartan; its salts; its esters; their salts
Olodaterol; its salts
Olsalazine; its salts
Omalizumab
Ombitasvir; its salts
Omeprazole; its salts
Omoconazole; its salts
Ondansetron; its salts
Opipramol; its salts; its derivatives; their salts
Opium
Orciprenaline; its salts
Orgotein
Orlistat; its salts
Orphenadrine; its salts
Orthocaine; its salts
Oseltamivir; its salts
Oteracil; its salts
Ouabain
Oxalic acid; its salts other than quadroxalates
Oxaliplatin; its salts
Oxanamide
Oxcarbazepine; its salts
Oxethazaine; its salts
Oxiconazole; its salts
Oxolamine; its salts
Oxprenolol; its salts
Oxycinchoninic acid; its derivatives; their salts; their esters
Oxycodone; its salts; its esters and ethers; their salts
Oxyfedrine; its salts

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Oxymorphone; its salts; its esters and ethers; their salts

Oxypertine
Oxyphenbutazone
Oxytocins
Paclitaxel
Paliperidone; its salts
Palivizumab
Palonosetron; its salts
Pamidronate; its salts
Pancuronium; its salts
Panitumumab
Pantethine; its salts
Pantoprazole; its salts
Paraldehyde
Paramethadione
Parecoxib; its salts
Pargyline; its salts
Paricalcitol; its salts; its esters; their salts
Paritaprevir; its salts
Paroxetine; its salts
Pasireotide; its salts
Pazopanib; its salts
Pefloxacin; its salts; its esters
Pegaptanib; its salts
Pegfilgrastim
Pegvisomant; its salts
Pemetrexed; its salts; its esters; their salts
Pemirolast; its salts
Pemoline; its salts
Pempidine; its salts
Penbutolol; its salts
Penciclovir; its salts
Penicillamine; its salts
Pentaerythritol tetranitrate
Pentamidine; its salts
Pentazocine; its salts
Pentolinium; its salts
Perampanel
Pergolide; its salts
Perindoprilat; its salts; its esters; their salts
Pertuzumab
Phenacemide
Phenacetin
Phenadoxone; its salts
Phenaglycodol
Phenampromide; its salts
Phenazocine; its salts; its esters and ethers; their salts
Phenbutrazate
Phencyclidine; its salts
Phenetidylphenacetin
Phenformin; its salts
Phenindione
Phenols (any member of the series of phenols of which the first member is phenol and of which the molecular
composition varies from member to member by 1 atom of carbon and 2 atoms of hydrogen) except in
substances containing less than 60%, weight in weight, of phenols; compounds of phenol with a metal,

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except in substances containing less than the equivalent of 60%, weight in weight, of phenols
Phenomorphan; its salts; its esters and ethers; their salts
Phenoperidine; its salts; its esters and ethers; their salts
Phenothiazine; its salts; its derivatives (except dimethoxanate); their salts (except salts of dimethoxanate); any
compound with any substance falling within this item
Phenoxybenzamine; its salts
Phenprenazone
Phenprobamate
Phentolamine; its salts
Phenylbutazone; its salts
2-Phenylcinchoninic acid; 2-salicylcinchoninic acid; their salts; their esters
5-Phenylhydantoin; its alkyl and aryl derivatives; their salts
4-Phenylpiperidine-4-carboxylic acid ethyl ester; its salts
Pholcodine; its salts; its esters and ethers; their salts
Picric acid
Picrotoxin
Pimecrolimus
Piminodine; its salts
Pioglitazone; its salts
Pipecuronium; its salts
Pipemidic acid
Pipobroman
Piritramide; its salts
Piromidic acid; its salts
Piroxicam
Pirprofen; its salts
Pituitary gland, the active principles of, other than corticotrophins, oxytocins and vasopressins
Pizotifen; its salts
Plerixafor; its salts
Podophyllum resin
Polymethylenebistrimethylammonium salts
Pomalidomide; its salts
Poractant alfa
Posaconazole; its salts; its esters; their salts
Pralidoxime; its salts
Pramipexole; its salts
Pramoxine; its salts
Prasugrel; its salts
Pravastatin; its salts; its esters
Prazosin; its salts
Pregabalin; its salts
Pridinol; its salts
Primaquine; its salts
Primidone
Prindolol; its salts
Probucol
Procainamide; its salts
Procarbazine; its salts
Procaterol; its salts
Procyclidine; its salts
alpha-Prodine; its salts
beta-Prodine; its salts
Proglumetacin; its salts
Proguanil; its salts
Proheptazine; its salts

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Promoxolane
Propafenone; its salts
Propanidid
Propiverine; its salts
Propofol
Propoxur; its salts
Propoxyphene; its salts; its optical isomers; their salts
Propranolol; its salts; its derivatives; their salts
Propylhexedrine; its salts
Propylthiouracil; its salts
Proquazone
Prostaglandins, the following and their derivatives
Alprostadil
Bimatoprost
Dinoprost
Dinoprostone
Latanoprost
Misoprostol
Travoprost
Unoprostone
their salts; their esters
Prothionamide
Prothipendyl; its salts
Protirelin; its salts
Protriptyline; its salts; its derivatives; their salts
Prucalopride; its salts
Prulifloxacin; its salts; its esters; their salts
Pseudoephedrine; its salts
Pyrazinamide
Pyricarbate (Pyridinolcarbamate)
Pyridostigmine; its salts
Pyrimethamine
Pyrithyldione
Quetiapine; its salts
Quinagolide; its salts
Quinapril; its salts
Quinethazone
Quinidine; its salts
Quinine; its salts; its derivatives; their salts
Rabeprazole; its salts
Racecadotril; its salts
Ractopamine; its salts
Radium-223; its salts; when contained in pharmaceutical products
Raloxifene; its salts
Raltegravir; its salts
Raltitrexed; its salts
Ramipril; its salts
Ranibizumab
Ranolazine; its salts
Rasagiline; its salts
Rasburicase; its salts
Reboxetine; its salts
Recombinant human erythropoietin
Regorafenib; its salts
Remifentanil; its salts

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Remoxipride; its salts

Repaglinide; its salts; its esters
Reproterol; its salts
Rescinnamine
Reteplase
Retigabine; its salts
Reviparin; its salts
Ribavirin; its salts
Rilmenidine; its salts
Rilpivirine; its salts
Riluzole; its salts
Rimiterol; its salts
Rimonabant; its salts
Riociguat; its salts
Risedronic acid; its salts
Risperidone
Ritodrine; its salts
Ritonavir; its salts
Rituximab
Rivaroxaban; its salts
Rivastigmine; its salts
Rizatriptan; its salts
Rocuronium; its salts
Rofecoxib; its salts
Roflumilast; its salts
Romiplostim
Ropinirole; its salts
Ropivacaine; its salts
Rosiglitazone; its salts
Rosoxacin; its salts
Rosuvastatin; its salts
Rotigotine; its salts
Rufinamide; its salts
Ruxolitinib; its salts
Salbutamol; its salts
Salmeterol; its salts
Saquinavir; its salts
Savin, oil of
Saxagliptin; its salts
Sermorelin; its salts
Sertaconazole; its salts
Sertindole; its salts
Sertraline; its salts
Sevelamer; its salts
Sibutramine; its salts; any compound containing the chemical structure of 1-[1-(4-Chlorophenyl)cyclobutyl]-3methylbutan-1-amine substituted to any degree or without substitution; its salts
Sildenafil; its salts; any compound containing the chemical structure of 5-(2-ethoxyphenyl)-1-methyl-3-propyl1H-pyrazolo[4,3-d]pyrimidin-7(6H)-one substituted to any degree or without substitution; its salts
Simvastatin
Sirolimus; its salts
Sitagliptin; its salts
Sodium aurothiomalate
Sodium cromoglycate
Sodium nitroprusside
Sofosbuvir; its salts

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Solifenacin; its salts; its esters; their salts

Somatostatin
Sorafenib; its salts
Sotalol; its salts
Sparfloxacin; its salts; its esters
Sparteine; its salts
Spinosad
Spironolactone
Stavudine; its salts
Streptokinase
Strontium ranelate
Strophanthus, glycosides of
Styramate
Sulconazole; its salts
Sulindac
Sulphinpyrazone
Sulphonal; alkyl sulphonals
Sulpiride
Sultopride
Sumatriptan; its salts
Sunitinib; its salts
Suprarenal gland, the active principles of; their salts; their derivatives; their salts
Sutoprofen; its salts
Suxamethonium; its salts
Syrosingopine
Tacrine; its salts
Tacrolimus
Tadalafil; its salts; any compound containing the chemical structure of 6-(Benzo[1,3]dioxol-5-yl)-2,3,6,7,12,12ahexahydropyrazino[1 ,2 :1,6]pyrido[3,4-b]indole-1,4-dione substituted to any degree or without
substitution; its salts
Tafluprost
Tamoxifen; its salts
Tapentadol; its salts
Tazarotene; its salts
Tegaserod; its salts
Telbivudine; its salts
Telmisartan; its salts
Temozolomide; its salts
Temsirolimus; its salts; its esters
Tenecteplase; its salts
Teniposide
Tenofovir; its salts; its esters; their salts
Tenoxicam
Terazosin; its salts
Terbinafine; its salts; except when contained in preparations for external application only with no more than 1%
of Terbinafine and not to be administered as a single application and when labelled for the treatment of
tinea pedis and/or tinea cruris only
Terbutaline; its salts
Terconazole; its salts
Teriflunomide; its salts
Teriparatide; its salts
Terodiline; its salts
Tertatolol; its salts
Tetrabenazine; its salts
Tetracosactide; its salts

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Thalidomide; its salts

Thallium, salts of
Theofibrate
Theophylline; its salts
Thiacetazone
Thiocarlide; its salts
Thioctic acid; its salts; its derivatives; when contained in pharmaceutical products
Thiotepa
Thymosin alpha 1
Thyroid gland, the active principles of; their salts
Thyrotropin alfa
Tiagabine; its salts; its esters; their salts
Tianeptine; its salts; its esters; their salts
Tiapride; its salts
Ticagrelor; its salts; its esters; their salts
Ticlopidine; its salts
Tiletamine; its salts
Tilidate; its salts
Tiludronic acid; its salts
Timolol; its salts
Tinidazole; its salts
Tinoridine; its salts
Tinzaparin; its salts
Tioconazole; its salts
Tiotropium; its salts
Tiratricol; its salts
Tirofiban; its salts
Tizanidine; its salts
Tocainide; its salts
Tocilizumab
Todralazine; its salts
Tofacitinib; its salts
Tofenacin; its salts
Tolazamide
Tolbutamide
Tolcapone; its salts
Tolfenamic acid; its salts
Tolmetin; its salts
Tolperisone; its salts
Tolterodine; its salts
Tolvaptan
para-Tolylmethylcarbinol nicotinic acid ester
Topiramate; its salts
Topotecan; its salts
Torasemide
Trabectedin; its salts; its esters
Tramadol; its salts
Trandolapril; its salts
Tranexamic acid
Tranylcypromine; its salts
Trastuzumab; its antibody drug conjugates
Trazodone; its salts
Tretamine; its salts
Tretinoin
Tretoquinol; its salts

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Triamterene; its salts

Triaziquone
Tribromoethyl alcohol
2,2,2-Trichloroethyl alcohol, esters of; their salts
Trifluridine; its salts
Trilostane
Trimeperidine; its salts
Trimetaphan; its salts
Trimetazidine; its salts
Trimethadione
Trimethoprim
Trimetozine
Trimetrexate; its salts
Trimipramine; its salts
Trioxsalen
Triptorelin; its salts
Tromantadine; its salts
Tropisetron; its salts
Trovafloxacin; its salts; its derivatives; their salts
Tulobuterol; its salts
Tybamate
Umeclidinium; its salts
Urapidil; its salts
Urethane
Urokinase
Ustekinumab
Valaciclovir; its salts
Valdecoxib; its salts
Valganciclovir; its salts
Valnoctamide
Valproic acid; its salts; its esters
Valsartan; its salts
Vandetanib; its salts
Vardenafil; its salts; any compound containing the chemical structure of 2-(2-ethoxyphenyl)-5-methyl-7propylimidazo[5,1-f][1,2,4]triazin-4(3H)-one substituted to any degree or without substitution; its salts
Varenicline; its salts
Vasopressins
Vecuronium; its salts
Vedolizumab
Vemurafenib; its salts
Venlafaxine; its salts
Veralipride; its salts
Verapamil; its salts
Vernakalant; its salts
Verteporfin; its salts
Vidarabine; its salts
Vigabatrin
Vilanterol; its salts
Vildagliptin; its salts
Viloxazine; its salts
Vindesine; its salts
Vinorelbine; its salts
Vismodegib; its salts
Vitamin A and its esters when contained in pharmaceutical products the recommended daily dose of which
contains not less than 10000 international units of vitamin A

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Voriconazole; its salts

Vortioxetine; its salts
Warfarin; its salts
Xamoterol; its salts
Xylazine; its salts
Zafirlukast
Zalcitabine; its salts
Zaleplon; its salts
Zanamivir; its salts
Zidovudine
Zimelidine; its salts
Zipeprol; its salts
Ziprasidone; its salts
Zofenopril; its salts
Zolazepam; its salts
Zoledronic acid; its salts
Zolmitriptan; its salts
Zolpidem; its salts
Zomepirac; its salts
Zopiclone
Zoxazolamine; its salts
(L.N. 34 of 2015; L.N. 67 of 2015; L.N. 100 of 2015; L.N. 193 of 2015)
Division B
Alkali fluorides other than those specified in Part II of this List
Barium, salts of, except barium sulphate
alpha-Chlorohydrin (3-chloro-1,2-Propanediol)
Dinitronaphthols; dinitrophenols; dinitrothymols
Hexachlorophane, the following
(a) medicinal products for human use containing more than 0.1% hexachlorophane;
(b) preparations for animal use
(i) aerosols the contents of the container of which contain more than 0.1% hexachlorophane;
(ii) soaps and shampoos containing more than 2% hexachlorophane;
(iii) other medicinal products (except those for oral administration to sheep or cattle for liver fluke
disease) containing more than 0.75% hexachlorophane
meta-Nitrophenol; ortho-nitrophenol; para-nitrophenol
Phosmet
Phosphorus, yellow
Sulphuric acid, except substances containing not more than 70%, weight in weight, of sulphuric acid
Part II
Division A
Antihistamine substances not included in Part I of this List; their salts; their compounds with any other substance
Benzocaine when contained in condoms
alpha-Chloralose
Loratadine; its salts; when contained in pharmaceutical products labelled for the relief of the symptoms of
allergic rhinitis only
Nicotine when contained in (a) chewing gum or lozenges, intended to be used in nicotine replacement therapy
and containing not more than 4 mg of Nicotine per piece; or (b) patches for external application, intended to
be used in nicotine replacement therapy
Pharmaceutical products retailed in the form as supplied by the manufacturer, containing a poison included in

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Division A of Part I of this List, where the proportion of the poison does not exceed the equivalent of
(a) 0.01% by weight of arsenic trioxide, cantharidin, cocaine, coniine, ecgonine, hydrocyanic acid,
strychnine, alkaloids of aconite, alkaloids of coca or alkaloids of gelsemium;
(b) 2%, weight in volume, of mercurochrome when contained in solutions for external use only; and
(c) 0.1% by weight in the case of other poisons,
except pharmaceutical products containing any poison
(d) included in the Third Schedule; or
(e) in the following list
Acetyldihydrocodeine; its salts
Alkaloids of belladonna; their salts
Alkaloids of ephedra; their salts
Atropine; its salts
Bambuterol; its salts
Benzydamine; its salts
Butropium; its salts
Codeine; its salts
Dextromethorphan; its salts
Diclofenac; its salts
Dihydrocodeine; its salts
Ethylmorphine; its salts
Fenoterol; its salts
Formoterol; its salts
Homatropine; its salts
Hyoscine; its salts
Hyoscyamine; its salts
Ipratropium; its salts
Methylaminoheptane; its salts
Morphine; its salts
Nicocodine; its salts
Norcodeine; its salts
Orciprenaline; its salts
Papaverine; its salts
Phenylpropanolamine; its salts
Pholcodine; its salts
Procaterol; its salts
Salmeterol; its salts
Terbutaline; its salts
Tretoquinol; its salts
Phenols as defined in Part I of this List in substances containing less than 60%, weight in weight, of phenols;
compounds of phenol with a metal in substances containing less than the equivalent of 60%, weight in
weight, of phenols
Terbinafine; its salts; when contained in preparations for external application only with no more than 1% of
Terbinafine and not to be administered as a single application and when labelled for the treatment of tinea
pedis and/or tinea cruris only
Division B
Ammonia
gamma-Benzene hexachloride (1,2,3,4,5,6-hexachlorocyclo-hexane)
Diamines, the following; their salts
Phenylene diamines; toluene diamines; other alkylated-benzene diamines
Formaldehyde
Formic acid
Hydrochloric acid

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Hydrofluoric acid; alkali fluorides; alkali metal bifluorides; ammonium bifluorides; sodium silicofluoride
Metallic oxalates
Nitric acid
Nitrobenzene
Phosphoric acid
Potassium hydroxide
Products retailed in the form as supplied by the manufacturer, containing a poison included in Division B of Part
I of this List, where the proportion of such poison does not exceed the equivalent of 0.1%
Sodium hydroxide
Sodium nitrite
(Schedule 10 added 2 of 2015 s. 71)

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