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TECHNICAL REGULATIONS RTCA 11.03.64: 19

CENTRAL AMERICAN ICS 11.120.10
1st. Revision

PRODUCTS PHARMACEUTICALS PRODUCTS

NATURAL MEDICINALS FOR HUMAN USE.
HEALTH REGISTRATION REQUIREMENTS.

CORRESPONDENCE: This regulation has no correspondence with any

document.

Edited by:

• Ministry of Economy, MINECO

• Salvadoran Technical Regulation Agency, OSARTEC
• Ministry of Development, Industry and Commerce, MIFIC
• Secretariat of Economic Development, SDE
• Ministry of Economy, Industry and Commerce, MEIC
• Ministry of Commerce and Industries, ICIM
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CENTRAL AMERICAN TECHNICAL REGULATIONS _RTCA 11.03.64: 19

REPORT

The respective technical regulatory technical committees through the entities of

technical regulation of the member states that make up the Central American region, and
their successors are the bodies responsible for conducting the study or the adoption of
technical regulations They are made up of government representatives, agencies of
consumer, academic and private sector protection.

This document was approved as Central American Technical Regulation

RTCA11.03.64: 19 PHARMACEUTICAL PRODUCTS. NATURAL PRODUCTS
MEDICINALS FOR HUMAN USE. HEALTH REGISTRATION REQUIREMENTS ,
by the Subgroups of Standardization Measures and Related Drugs and Products of the
Central American Region The officialization of this technical regulation entails the
approval by the Council of Economic Integration Ministers (COMIECO).

COMMITTEE PARTICIPATING MEMBERS

For Guatemala:
Ministry of Public Health and Social Assistance

For El Salvador:
National Directorate of Medicines

For Nicaragua:
Ministry of Health

For Honduras:
Health Regulation Agency

For Costa Rica:

Ministry of Health

For Panama:
Ministry of Health

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CENTRAL AMERICAN TECHNICAL REGULATIONS _RTCA 11.03.64: 19

one. OBJECT
Establish the conditions and requirements under which the sanitary registration of
Natural medicinal products for human use for commercialization.

two. SCOPE

Applies to natural medicinal products for human use that manufacture or import,
natural or legal persons for commercialization in the States Parties of the region
Central American

Products to which synthetic active substances are added are excluded.

chemical or isolated from natural material as responsible for pharmacological activity, as well
as the pharmaceutical forms that are applied by the ophthalmic and parenteral route.

3. DOCUMENTS TO CONSULT

3.1 RTCA Pharmaceutical Products. Natural Medicinal Products for use

Human. Labeling Requirements Valid.

3.2 RTCA Pharmaceutical Products. Natural Medicinal Products for use

Human. Quality Verification. Valid.

3.3 RTCA Pharmaceutical Products. Natural Medicinal Products For Use

Human. Good manufacturing practices. Valid.

Four. DEFINITIONS

4.1 Competent Authority: authority responsible for issuing the Certificate of

Free Sale and Certificate of Good Manufacturing Practices for natural products
Medicinal in each country or region.

4.2 Regulatory Authority: authority responsible for health regulation in each

Country or region.

4.3 Good Manufacturing Practices : set of procedures and standards

intended to ensure the uniform production of lots of natural products
Medicines to meet quality standards.

4.4 Certificate of Good Manufacturing Practices: document issued by the

competent authority of the country in which the manufacturing laboratory is located
where it is certified that the laboratory complies with good manufacturing practices.

4.5 Free Sale Certificate: document issued by the competent authority of the
country of origin or of origin, in which it certifies that the medicinal natural product has
your current registration and you are authorized for sale or distribution in that country.

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CENTRAL AMERICAN TECHNICAL REGULATIONS _RTCA 11.03.64: 19

In the case of manufacturing by third parties or subsidiaries and the product is not marketed in the
country of origin, may be issued by the competent authority of the holder's country.

4.6 Certificate of registration: official document issued by the competent authority that
authorizes marketing a natural medicinal product.

4.7 Committee of experts: group of people who, due to their suitability, are recognized by the
regulatory authority, to endorse the documents that support the use and security of a
natural active substance or a medicinal natural product.

The formation of the group of experts will be convened by the regulatory authority, when
I consider it necessary.

4.8 Manufacturing contract: legal document concluded between the owner of the product
medicinal natural and the manufacturer in which the conditions, commitments and
other circumstances for the manufacture of one or more products.

4.9 Natural drug : substance of natural origin and with activity that is used alone or
combined in the elaboration of natural medicinal products.

4.10 Packaging or container: material used to protect in handling, storage and

transport to the medicinal natural product.

4.11 Primary packaging or container: container or container in which it is placed

directly the finished medicinal natural product.

4.12 Secondary packaging or packaging: final distribution and marketing package

or packing material into which the primary container containing the
Natural medicinal product in its definitive pharmaceutical form.

4.13 Specific epithet: Latinized name that accompanies the genre, to form the name
Binomial of a species.

4.14 Stability studies: tests performed to determine the period of

validity of the medicinal natural product in its original primary container and in conditions of
specified storage.

4.15 Labeling: mandatory information included in the label, label, image or other
descriptive or graphic matter that has been written, printed, stenciled or marked in relief,
which is attached or included in the package of a medicinal natural product.

4.16 Excipient: substance without pharmacological action at the concentration used, which
determines or modifies the consistency, shape, volume or physicochemical properties of the
preparations of natural medicinal products.

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CENTRAL AMERICAN TECHNICAL REGULATIONS _RTCA 11.03.64: 19

4.17 Extract: preparations of liquid consistency (fluid extracts and tinctures),

semi-solid (soft extracts) or solid (dry extracts), obtained from drugs
natural.

4.18 Standardized extract : extract that provides a minimum level or specific range of
one or more constituents, whether or not they have pharmacological activity, provided that
this one maintains the identity of the natural drug from where it comes.

4.19 Manufacturing to third parties : domestic or foreign manufacturing carried out within the
limits of a previous contracting between the holder of the medicinal natural product and the
manufacturer, the owner being responsible for the product.

4.20 Expiration or expiration date : date established for each lot placed on the
primary and secondary packaging until which the medicinal natural product is expected,
Stored properly meet quality specifications.

4.21 Modality of sale: variants by means of which they can be marketed

natural medicinal products, these being the following:

4.21.1 Prescription product under medical prescription or prescription product;

4.21.2 Over the counter product.

4.21.3 Retained prescription product.

4.22 Monograph of finished product: technical scientific description of the profile of

Safety and efficacy, according to the level of evidence of a natural medicinal product.

4.23 Scientific name: binary name of the species, formed by genus and epithet
specific.

4.24 Country of origin: country where the product is manufactured. In case of manufacturing
Intervene more than one manufacturing laboratory, the country of origin is the one in which the
manufacture of at least the bulk product.

4.25 Country of origin: country from which the country is distributed, conditioned or exported
product. Provided that they intervene in the manufacturing process; at least until
primary packing

4.26 Natural preparation: it is the one obtained from the natural raw material by
fractionation process, solvent extraction, expression, distillation,
purification, fermentation, concentration or any other physical or biological process.

4.27 Natural medicinal product : product processed, industrialized and labeled with
medicinal properties, which contains in its formulation ingredients obtained from the
plants, animals, minerals or mixtures of these. May contain excipients in addition to
natural material Natural medicinal products to which substances are added

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CENTRAL AMERICAN TECHNICAL REGULATIONS _RTCA 11.03.64: 19

chemical synthesis active or isolated from natural material as responsible for the activity
Pharmacological, they are not considered as natural medicinal products.

4.28 Traditional medicinal natural product: it is one whose use and safety of
Natural active substances is justified by ethnomedicinal reports, documentation
technical and scientific, indexed publications or documents endorsed by a committee of
experts They are used by oral, topical or other route that does not require sterility.

4.29 Retained prescription product: it is the authorized natural medicinal product for
marketed under a retained prescription, as applicable.

4.30 Responsible professional : pharmaceutical professional or pharmaceutical chemist,

responsible for the sanitary registration process before the regulatory authority, authorized by the
owner of the product or its legal representative through a power of attorney granted according to the
legislation of each State Party.

4.31 Sanitary registration: approval procedure by the competent authority of a

country for the commercialization of a medicinal natural product, once it has
After the evaluation process related to quality, efficiency and safety.

4.32 Legal representative: natural or legal person residing in the country where it is processed
the registration, authorized by the owner of the medicinal natural product, through a power of attorney
granted in accordance with the legislation of each State Party, to respond to the
regulatory authority

NOTE: in the case of El Salvador, the figure of the legal representative or proxy may be used .

4.33 Natural active substance : chemically defined substance or groups of substances,

whose pharmacological action is known and is responsible for therapeutic effects present in
The natural medicinal product. When the chemicals mentioned are unknown
previously, the natural drug or the natural preparation is considered active substance.

4.34 Product holder or registration holder : natural or legal person who owns the
product.

4.35 Traditional use : it is supported by documentary evidence that states that the
natural drug that is used in a product, has been used for three or more decades
For medicinal purposes.

4.36 Shelf life: period during which a product is expected, if stored

correctly, keep the established specifications.

5. INGREDIENT ACCEPTANCE CATEGORIES IN A

NATURAL MEDICINAL PRODUCT

5.1. Ingredients accepted:

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5.1.1 Natural drugs

5.1.2 Natural preparations.

5.1.3 Combinations of any of the above.

5.1.4 Pharmaceutically accepted excipients.

5.2 Ingredients not accepted:

5.2.1 Isolated molecules of natural ingredients and synthetic or semi-synthetic compounds

chemistry used as active ingredient, which by definition are excluded from products
Natural medicinal

5.2.2 Natural substances prohibited in accordance with international recommendations or

the regulation issued in each State Party.

5.2.3 Species identified as protected or endangered unless

come from managed crops or upbringing.

5.2.4 Homeopathic ingredients (strains, mother tinctures and dilutions).

6. PHARMACEUTICAL FORMS

All pharmaceutical forms that demonstrate its safety and efficacy are accepted, except
those that are applied by the ophthalmic and parenteral route.

7. PROVISIONS FOR THE SANITARY REGISTRATION

7.1 For import, production, distribution, marketing, prescription,

promotion and advertising, all natural medicinal products require prior registration
health before the regulatory authority.

7.2 The sanitary registry of natural medicinal products will be valid for five
years, which may be suspended or canceled when there are sanitary reasons of a character
scientific, technical or legal duly justified.

7.3 Any official or legal document issued abroad must be legalized or

Apostille legalize in compliance with the specific national regulations.

7.4 Any official or legal document required for registration must be current in the
time of presentation The official documents will have the validity granted by the
competent authority of the country where it is issued. In cases where the
validity, this will be 2 years for the purposes of the registration process from the date of
issue.

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7.5 All official or legal documents must be submitted in original or legalized copy or
Apostilled in accordance with the legislation of each State Party. The document must be
present in Spanish / Spanish language or in case of presenting in another language, it must be
accompanied by their respective translation issued in accordance with the legislation of each
State party

7.6 No corrections are allowed in certifications or in official documents

filed, unless supported by the same instance that issued the document
original.

7.7 In those cases in which it applies and for the purposes of registering a natural product
specific medicine, the applicant will be allowed to refer to documents
current originals that are on file with the regulatory authority. In this case the
Applicant must refer to the management in which the original document was delivered,
presenting a simple photocopy of it.

7.8 The administrative procedure for the process of sanitary registration, renovation and
modifications will be made in accordance with the internal legislation of each State Party.

7.9 Failure to comply with these regulations will result in the application of the
established in the sanction regime of each State Party.

7.10 This Central American Technical Regulation of Pharmaceutical Products. products

Natural Medicines for Human Use. Sanitary Registration Requirements, repeal
only the provisions of the requirements for sanitary registration, renovation and
modifications of natural medicinal products of the internal regulation of each
State party

7.11 Correspond to the same record:

7.11.1 Different commercial presentations of medications with the same

concentration and the same pharmaceutical form.

7.11.2 Medicines with the same qualitative-quantitative formula and different taste and / or color.

8. REQUIREMENTS FOR HEALTH REGISTRATION

8.1 Proof of payment.

8.2 Health registration application signed and stamped by the responsible professional,
containing the detailed information Annex A.

8.3 Powers that accredit the legal and / or technical representation granted by the holder to
the natural person (s) or legal entity (s) in accordance with the legislation of each country. (original
or authenticated photocopy of the document).

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8.4 Certificate of free sale of the product, issued by the competent authority of the country
of origin or provenance.

8.5 Certificate of Good Manufacturing Practices, of each of the

establishments involved in the manufacture of the product, when not included in
the free sale certificate, declaring the pharmaceutical form and type of product to
register, extended by the competent authority of the country or countries where it is carried out
the manufacturing process, or equivalent document issued by the competent authority,
document issued by the regulatory authority indicating that it conducts inspections
periodic to the establishment but that does not extend the certificate of good practices of
manufacture.

8.6 Manufacturing contract or otherwise the relative extract of the parts of the contract
of manufacture, when applicable, in original or certified or certified photocopy of the
legalized or apostilled document, containing at least the following information:

8.6.1 Signed by the holder and the manufacturer jointly or separately.

8.6.2 Commitment to compliance with good manufacturing practices.

8.6.3 Establish the conditions of production, analysis, when applicable or any other
technical management related to these.

8.6.4 Should describe the handling of raw materials, conditioning material,

bulk product and finished product and if rejected.

8.6.5 Allow the contractor to enter the contractor's premises (contracted)

for audits

8.6.6 Allow the contractor (contracted) to enter the contractor's premises.

8.6.7 List each of the products or services of analysis object of the contract.

8.7 Complete qualitative and quantitative formula of the product per dose unit. I know
must present in original signed and stamped by the professional responsible for the laboratory
manufacturer or holder of the product, indicating:

8.7.1 Name (s) of the active substance (s):

8.7.1.1 Scientific name of the organism from which drugs or preparations are obtained
natural, indicating the part or organ used.

8.7.1.2 Internationally accepted chemical name or denomination, for drugs

minerals or their preparations.

8.7.2 Solvent used, in liquid extracts. If the solvent is ethanol, you must declare the
percentage.

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8.7.3 Drug / solvent or excipient ratio, in case of extracts or standardization

declared by the manufacturer of the extract.

NOTES :

1) All excipients of the product must be described with their name internationally
accepted.
2) The units of each component must be given according to the international measurement system (SI).

8.7.4 Qualitative composition of empty capsules.

8.7.5 Qualitative composition of printing inks in capsules, dragees and

coated tablets

8.7.6 In the case of pharmaceutical forms with a topical route of administration, the
formulation should be presented for each g, 100 g, mL or 100 mL or percentage.

8.8 Monograph of the finished product.

The monograph must correspond to the pharmaceutical form of the product to be registered, which
It must contain the following information:

NOTES:

1) When the information requested is not applicable to the product's own characteristics, it may
ignore in the monograph.
2) For Panama, they must include precautions regarding excipients, which are published through
internal resolution

8.8.1 Product name.

8.8.2 Composition:

8.8.2.1 Scientific name of the organism from which drugs or preparations are obtained
natural, indicating the organ used.

8.8.2.2 Internationally accepted chemical name or denomination, for drugs

minerals or their preparations.

8.8.3 Pharmaceutical form.

8.8.4 Form of preparation.

8.8.5 Pharmacological information, including:

8.8.5.1 Indications.

8.8.5.2 Contraindications.

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8.8.5.3 Precautions and warnings.

8.8.5.4 Maximum time of use, when applicable.

8.8.5.5 Interactions.

8.8.5.6 Adverse effects.

8.8.5.7 Dose and route of administration.

8.8.5.8 Recommendation in case of overdose or abuse, when applicable.

8.8.5.9 Bibliographic references.

8.8.5.10 Monograph revision date.

8.9 Safety and efficacy information in accordance with Annex C of this

technical regulation

8.10 Analytical methodology.

8.11 Specifications of the finished product.

8.12 Labeling of primary, secondary and insert packaging or packaging (as applicable), in
original or its projects, according to current regulations.

8.13 Stability study report.

NOTES:

1) As long as the RTCA Stability Studies for Natural Medicinal Products does not take effect, it
will require the report of analysis of the physical, chemical and microbiological tests according to the
established in the RTCA Pharmaceutical Products. Natural Medicinal Products for Human Use.
Quality Verification, current.
2) In the case of Panama, a useful life period of more than 24 months will not be granted.

8.14 A copy of the finished product, for pharmaceutical evaluation.

8.15 Samples of original finished product, according to harmonized quantity to make

the analyzes, according to the RTCA Pharmaceutical Products. Natural products
Medicinal products for human use. Quality Verification, current.

8.16 Standards or standardized raw material for analysis, when the

Analysis methodology requires it.

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 NOTES:

1) Requirement 8.14 will not apply in the case of Guatemala since the analysis samples are used.
2) Requirements 8.15 and 8.16 will be requested after the registration of the medicinal natural product for the case
from Costa Rica, El Salvador and Nicaragua.

9. REQUIREMENTS FOR THE RENEWAL OF THE SANITARY REGISTRY

The renewal of the sanitary registry of a natural medicinal product may be managed by
At least three months before its expiration.

Once the sanitary registration has expired, the product cannot be marketed.
Be processed as a new record.

If during the 6 months after the expiration of the registration of the natural product
medicinal, the interested party requests to keep the assigned number presenting the cause
justified, the regulatory authority will keep the original number, however, during
This period, you will not be able to market it.

Renewal will not be granted, until the requested post-registration changes have been approved.

9.1 When the product maintains the information and characteristics that have been
Approved during the validity of the registration, when requesting renewal they must present:

9.1.1 Proof of payment for registration renewal.

9.1.2 Application for renewal of sanitary registration signed and stamped by the professional
responsible containing the detailed information in Annex A.

9.1.3 Affidavit issued by the holder or his legal representative or by the professional
responsible for the registration by means of power issued by the owner of the product, that the
product information and features have not changed since the last request for
modification submitted to the regulatory authority.

9.1.4 Certificate of free sale of the product, issued by the competent authority of the country
of origin or provenance.

9.1.5 Certificate of good manufacturing practices of each of the establishments

involved in the manufacture of the product, when it is not included in the certificate of
free sale, declaring the pharmaceutical form and type of product to be renewed, extended by the
competent authority of the country or countries where the manufacturing process is carried out or
equivalent document issued by the competent authority, or document issued by the
regulatory authority indicating that it conducts periodic inspections at
establishment but does not extend the certificate of good manufacturing practices.

9.1.6 Stability Study Report confirming the approved lifespan.

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 NOTES:

1) As long as the RTCA Stability Studies for Natural Medicinal Products does not take effect, it
will require the report of analysis of the physical, chemical and microbiological tests according to the
established in the RTCA Pharmaceutical Products. Natural Medicinal Products for Human Use.
Quality Verification, current.
2) In the case of Panama, a useful life period of more than 24 months will not be granted.

9.2 In cases where the medicinal natural product presents modifications to the
health record that are not known to the regulatory authority may
be requested simultaneously to the renewal.

In the same way, if the affidavit cannot be presented, in both cases they must
meet the following requirements:

9.2.1 Proof of payment.

9.2.2 Application for renewal of sanitary registration and of the signed and
sealed by the responsible professional, containing the detailed information Annex A.

9.2.3 Powers that accredit the legal and / or technical representation granted by the holder to
the natural person (s) or legal entity (s) according to the legislation of each country. (original or
authenticated photocopy of the document).

9.2.4 Certificate of free sale of the product, issued by the competent authority of the country
of origin or provenance.

9.2.5 Certificate of good manufacturing practices, in accordance with the provisions of the
8.5 of registration requirements.

9.2.6 Manufacturing contract, when applicable, in accordance with 8.6 of

registration requirements

9.2.7 Complete qualitative and quantitative formula of the product per dose unit,
in accordance with paragraph 8.7 registration requirements.

9.2.8 Specifications of the finished product.

9.2.9 Labeling of primary, secondary and insert packaging or packaging (as applicable), in
original as it is being marketed, according to current labeling regulations.

NOTE: When the product has not been commercialized, the print art project of the product will be accepted.
primary and secondary packaging in Spanish, accompanied by an affidavit from the holder of the
product indicating that the product has not been marketed.

9.2.10 Stability Study Report confirming the period of useful life.

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 NOTES:

1) As long as the RTCA Stability Studies for Natural Medicinal Products does not take effect, it
will require the report of analysis of physical, chemical and microbiological tests in accordance with the
established in the RTCA Pharmaceutical Products. Natural Medicinal Products for Human Use.
Quality Verification, current.
2) In the case of Panama, a useful life period of more than 24 months will not be granted.

9.2.11 According to the requested modification, you must present the documents according to Annex B.

10. CAUSES OF NON GRANTING OF THE SANITARY REGISTRY.

The health authorities of the States Parties shall not issue the sanitary record of a
product when:

10.1 Do not comply with the requirements established in the RTCA .

10.2 The documentation submitted according to current technical regulations is

incomplete, incorrect or not current.

10.3 The formula contains ingredients reported as unsafe, or in doses and routes not
allowed.

10.4 The formula contains ingredients with antagonistic therapeutic effects.

10.5 There is a discrepancy between the analytical result and the documentation presented.

NOTE: This case will not apply in the case of Costa Rica, El Salvador, Honduras and Nicaragua.

10.6 Lacking in its dosage of therapeutic efficacy or safety as indicated

in the table in Annex C: Classification of natural active substances based on the
safety and efficacy.

10.7 That the studies or research presented in support of the application be

incomplete, or insufficient to demonstrate the quality, safety and efficacy of the product
as indicated in the table in Annex C: Classification of natural active substances
based on safety and effectiveness.

eleven. CAUSES OF CANCELLATION OF THE SANITARY REGISTRY

The health authorities of the States Parties shall cancel the sanitary registration of a
product when:

11.1 Check that the product proves to be harmful or unsafe under the conditions
normal use.

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11.2 For falsification or alteration of the documents submitted to the authority

Regulatory
 11.3 When it is shown that the product does not have the quantitative composition or
qualitative authorized or when quality and stability guarantees are breached
declared in the file, following due process according to the legislation of each
State party

11.4 When requested by the product owner.

11.5 It has been demonstrated with conclusive scientific evidence that the product does not have
The therapeutic properties with which it was initially registered.

11.6 That prior warning is continued breaching the RTCA Products

Pharmacists Natural Medicinal Products for Human use. Requirements of
Labeling, in its current version

12. MODIFICATIONS TO THE SANITARY REGISTRY

Any modification to the information that is made after the sanitary registration must
comply with the provisions of Annex B.

When there are changes of natural active substances, pharmaceutical form and
Product concentration, must submit a new record.

13. SURVEILLANCE AND VERIFICATION

The supervision and verification of this technical regulation corresponds to the authorities
Regulatory States Parties.

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ANNEX A
(NORMATIVE)
APPLICATION FOR THE SANITARY RECORD. REQUIRED INFORMATION
 one. Product dates
1.1 Product name.
1.2 Name of natural active substances.
1.3 Pharmaceutical form
1.4 Route of administration.
1.5 Product presentation.
1.6 Proposed lifespan.
1.7 Modality of sale.
1.8 Registration category (new, renewal).

two. Manufacturer and conditioner data

2.1 Name and country of the laboratory (s) involved in manufacturing.
2.2 Address, telephone and email.
2.3 Manufacturing stage.
2.4 Health license number or operating health permit and date of
expiration, (when national).

3. Product holder data

3.1 Name
3.2 Address, telephone, and email.
3.3 Country
Four. Data of the distributor (s)
4.1 Name of the distributor (s).
4.2 Address, telephone, fax and email.
4.3 Health license number and expiration date.

5. Data of the legal representative

5.1 Name
5.2 Identity document number.
5.3 Address, telephone, and email.

6. Responsible professional data

6.1 Name
6.2 Identity document number.
6.3 Address, telephone, and email.
6.4 Collegiate or pharmaceutical chemical registration number.

7. Legend that gives you the character of an affidavit in the application.

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ANNEX B
(NORMATIVE)
REQUIREMENTS FOR CHANGES TO THE SANITARY REGISTRY

B1) Modifications that require prior approval by the regulatory authority.

 MODIFICATION REQUIREMENTS
1. In the commercial presentation. 1. Proof of payment.
2. Application signed and stamped by the professional
responsable.
3. New original container labels
primary, secondary or its projects according
RTCA Pharmaceutical Products. products
Natural Medicines for Human use.
Labeling Requirements, current.
4. Document issued by the holder or his
legal representative to declare the change.
2. In the name of the product 1. Proof of payment.
2. Application signed and stamped by the professional
responsable.
3. Document issued by the holder or his
legal representative to declare the change of
Name.
4. New original container labels
primary, secondary or its projects according
RTCA Pharmaceutical Products. products
Natural Medicines for Human use.
Labeling Requirements, current.
3. Social name of the manufacturer, 1. Proof of payment.
packer or holder 2. Application signed and stamped by the professional
responsable.
3. Legal document proving the change.
4. New original container labels
primary, secondary or its projects according
RTCA Pharmaceutical Products. products
Natural Medicines for Human Use.
Labeling Requirements, current.
4. In the monograph and insert. 1. Proof of payment.
2. Application signed and stamped by the professional
responsable.
3. Monograph and insert updated with
requested changes.
4. Bibliographic reference or otherwise,
studies as established in the requirements
Registration supporting the change.
5. Document issued by the holder or his

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legal representative that accredits the change.

5. In the period of useful life. 1. Proof of payment.
2. Application signed and stamped by the professional
responsable.
3. Stability study report confirming
the proposed lifespan.
 NOTES:

1) As long as the RTCA Studies of

Stability for Natural Medicinal Products, is
will require the physical evidence analysis report,
chemical and microbiological according to the established
in the RTCA Pharmaceutical Products. products
Natural Medicinal For Use Human.
Quality Verification, current.
2) In the case of Panama, a period of
shelf life greater than 24 months.

4. Document issued by the holder or his

legal representative that accredits the change.
6. In the terms from 1. Proof of payment.
storage. 2. Application signed and stamped by the professional
responsable.
3. Stability study report to support
The requested conditions.

NOTES:

1) As long as the RTCA Studies of

Stability for Natural Medicinal Products, is
will require the physical evidence analysis report,
chemical and microbiological according to the established
in the RTCA Pharmaceutical Products. products
Natural Medicines for Human use. check
of Quality, in force.
2) In the case of Panama, a period of
shelf life greater than 24 months

4. New original container labels

primary, secondary or its projects according
RTCA Pharmaceutical Products. products
Natural Medicines for Human use.
Labeling Requirements, current.
5. Document issued by the holder or his
legal representative that accredits the change.
7. Primary packer 1. Proof of payment.
2. Application signed and stamped by the professional
responsable.
3. Certificate of good manufacturing practices
of the new packer.

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CENTRAL AMERICAN TECHNICAL REGULATIONS _RTCA 11.03.64: 19

4. Contract with the new packer, in case of

third party manufacturing.
5. New original container labels
primary, secondary or its projects according
RTCA Pharmaceutical Products. products
Natural Medicines for Human use.
Labeling Requirements, current.
6. Affidavit stating that
 they maintain the same conditions regarding the
Qualitative-quantitative formula, type and material of
primary packing, process and place of
Manufacture of the registered product.
7. Document issued by the holder or his
legal representative that accredits the change.

NOTES:

1) As long as the RTCA Studies of

Stability for Natural Medicinal Products, is
will require the physical evidence analysis report,
chemical and microbiological according to the established
in the RTCA Pharmaceutical Products. products
Natural Medicines for Human use. check
of Quality, in force.
2) In the case of Panama, a period of
shelf life greater than 24 months.
8. From secondary packer 1. Proof of payment.
2. Application signed and stamped by the professional
responsable.
3. Certificate of good manufacturing practices
of the new packer.
4. Contract with the new packer, in case of
third party manufacturing.
5. New original container labels
primary, secondary or its projects according
RTCA Pharmaceutical Products. products
Natural Medicines for Human Use.
Labeling Requirements, current.
6. Document issued by the holder or his
legal representative that accredits the change.
9. Type of packing material 1. Proof of payment.
primary or container-closure system. 2. Application signed and stamped by the professional
responsable.
3. Stability study report.

NOTES:

1) As long as the RTCA Studies of

Stability for Natural Medicinal Products, is
will require the physical evidence analysis report,

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CENTRAL AMERICAN TECHNICAL REGULATIONS _RTCA 11.03.64: 19

chemical and microbiological according to the established

in the RTCA Pharmaceutical Products. products
Natural Medicines for Human use. check
of Quality, in force.
2) In the case of Panama, a period of
shelf life greater than 24 months.

4. Specifications of the primary packaging or

container-closure system.
5. Document issued by the holder or his
legal representative that accredits the change.
 10. Adding a new package 1. Proof of payment.
primary 2. Application signed and stamped by the professional
responsable.
3. Stability studies report for the
packaging requested.

NOTE: Until RTCA goes into effect

Stability Studies for Natural Products
Medicinal, the Analysis Report of the
physical, chemical and microbiological tests according to
established in the RTCA Pharmaceutical Products.
Natural Medicinal Products for Human use.
Quality Verification, in force, to demonstrate that the
Product is within the specifications
presented in the registration dossier for the new
packing.

4. New original container labels

primary, secondary (when applicable) or its
Projects according RTCA products
Pharmacists Natural Medicinal Products
for human use. Labeling Requirements,
valid.
5. Specifications of the primary packaging.
6. Document issued by the holder or his
legal representative that accredits the change.

NOTES:

1) As long as the RTCA Studies of

Stability for Natural Medicinal Products, is
will require the physical evidence analysis report,
chemical and microbiological according to the established
in the RTCA Pharmaceutical Products. products
Natural Medicinal for Use Human.
Quality Verification, current.
2) In the case of Panama, a period of
shelf life greater than 24 months.
11. Holder 1. Proof of payment.
2. Application signed and stamped by the professional
responsable.

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CENTRAL AMERICAN TECHNICAL REGULATIONS _RTCA 11.03.64: 19

3. New original container labels

primary, secondary or its projects according
RTCA Pharmaceutical Products. products
Natural Medicines for Human use.
Labeling Requirements, current.
4. Legal document proving the change
attaching the new powers.
5. Contract in accordance with paragraph 8.6 in case
Manufacturing by third parties.
12. In case of manufacturing by 1. Proof of payment.
third parties: 2. Application signed and stamped by the professional
 responsable.
to) Change of manufacturer 3. Certificate of free sale of the product.
4. New original container labels
b) Change of manufacturer and primary, secondary or its projects according
country of origin. RTCA Pharmaceutical Products. products
Natural Medicines for Human use.
Labeling Requirements, current.
5. Certificate of good manufacturing practices
from the new manufacturer.
6. Stability study report.
NOTE: Until RTCA goes into effect
Stability Studies for Natural Products
Medicinal, the analysis report of the
physical, chemical and microbiological tests according to
established in the RTCA Pharmaceutical Products.
Natural Medicinal Products for Human Use.
Quality Verification, to demonstrate that the
Product is within the specifications
presented in the registration dossier for the product
manufactured in the new plant.

7. A copy of the finished product.

8. Samples of the finished product for analysis
according to what is established in the RTCA
Pharmaceutical products. Natural products
Medicinal products for human use. Verification of
Quality, current.
NOTE : In the case of Costa Rica and El Salvador does not apply
the presentation of samples, because post-analysis is done
approval.

9. Analytical methodology.
10. Contract with the new manufacturer of
compliance with numeral 8.6.
11. Document issued by the holder or his
legal representative that accredits the change.
13. Modality of sale 1. Proof of payment.
2. Application signed and stamped by the professional

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responsable.
3. Information justifying the change issued
by the owner or his legal representative.
4. New original container labels
primary, secondary or its projects according
RTCA Pharmaceutical Products. products
Natural Medicines for Human Use.
Labeling Requirements, current.
14. Change of excipients or change 1. Proof of payment.
in their concentration. 2. Application signed and stamped by the professional
responsable.
3. Qualitative quantitative formula per unit dose
 4. Stability study report.
NOTES:

1) As long as the RTCA Studies of

Stability for Natural Medicinal Products, is
will require the physical evidence analysis report,
chemical and microbiological according to the established
in the RTCA Pharmaceutical Products. products
Natural Medicinal For Use Human.
Quality verification, current.
2) In the case of Panama, a period of
shelf life greater than 24 months.

5. Samples of finished product with its

specifications, when applicable.

NOTE : In the case of Costa Rica and El Salvador, the

presentation of samples, because it makes post-analysis
approval.

6. Technical justification for the change.

7. Analytical methodology of the finished product,
when applicable
8. Specifications of the finished product
updated, when applicable.
9. Document issued by the holder or his
legal representative that accredits the change.
15. Information on labeling 1. Proof of payment.
primary and secondary 2. Application signed and stamped by the professional
responsable.
3. New original container labels
primary, secondary or its projects according
RTCA Pharmaceutical Products. products
Natural Medicines for Human use.
Labeling Requirements, current.
4. Technical justification for the change issued by the

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holder or his legal representative.

16. Manufacturing site within a 1. Proof of payment.
same country. 2. Application signed and sealed.
3. Certificate of good manufacturing practices.
4. Affidavit of the owner of the product or
legal representative stating that
Manufacturing conditions have not changed.
5. Document issued by the holder or his
legal representative that accredits the change.
17. Of legal representative or 1. Proof of payment.
responsible professional. 2. Application signed and stamped by the professional
responsable.
3. Power granted according to the legislation of
 each State Party that accredits the change.
18. Change of pharmaceutical form, 1. A health record must be performed.
route of administration, concentration
and species of the active substance.

19. Change or update in 1. Proof of payment.

specs of the product 2. Application signed and stamped by the professional
finished. responsable.
3. New specifications of the finished product
that complies with the provisions of the RTCA
Quality Verification, current.
4. Justification supporting the requested change
accompanied by scientific information in the
That such change is supported.
5. Document issued by the holder or his
legal representative to declare the change.
20. Change or update in the 1. Proof of payment.
analytical methodology. 2. Application signed and stamped by the professional
responsable.
3. Full description of the analysis methods
(when it is not pharmacopeic).
4. Validation documentation
5. Justification supporting the change.
6. Document issued by the holder or his
legal representative to declare the change.
21. Extension of indications 1. Proof of payment.
therapeutic 2. Application signed and stamped by the professional
responsable.
3. Therapeutic monograph and updated insert.
4. Clinical studies that support the new
indication. (when applicable).
5. Document issued by the holder or his
legal representative to declare the change.

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B2) Modifications that must be notified to the regulatory authority and not
Require prior approval.

MODIFICATION REQUIREMENTS
1. Material or dimensions of 1. Notification signed and stamped by the professional
secondary package. responsable.
2. Document issued by the holder or his
legal representative to declare the change.
3. Original packaging or your projects.
2. Label design 1. Notification signed and stamped by the professional
primary and secondary packaging. responsable.
2. Document issued by the holder or his
legal representative to declare the change.
3. Original packaging or your projects.
3. Discontinuation from 1. Notification signed and stamped by the professional
 Registered presentations responsable.
2. Document issued by the holder or his
legal representative to declare the change.

4. Change or extension of 1. Proof of payment.

distributor. 2. Application signed and stamped by the professional
responsable.
3. Legal document issued by the holder or his
legal representative that endorses the change or the
extension.
5. Change in information 1. Proof of payment.
product safety 2. Application signed and stamped by the professional
responsable.
3. Document that supports the change.
4. Monograph and insert with the indicated change
When the product includes it.

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ANNEX C
(NORMATIVE)
CLASSIFICATION OF NATURAL ACTIVE SUBSTANCES BASED ON THE
SAFETY AND EFFICACY

1. Security levels: based on the general guidelines of the Policy Agency and
United States Health Research (AHCPR), World Organization of the
Health (WHO / WHO) and the European Medicines Agency (EMA) substances
Natural assets are classified according to their safety and effectiveness as follows
shape:

Level of
Type of evidence Grade
evidence
Ia Meta-analysis of randomized controlled trials
TO
Ib At least one randomized controlled clinical trial
IIa At least one controlled study, with witness, not randomized
 IIb Minimum of one type of experimental study. B
III Descriptive, non-experimental studies, such as studies
comparatives, correlation or case-control
IV Reports of expert committees, opinions or clinical experience of
C
recognized authorities
V Traditional use T

2. Recommendations for classification: the general guidelines of AHCPR, WHO and

EMEA for natural active substances, establish the following recommendations
for the support of its classification based on its safety and efficacy:

Grade Recommendation
TO Requires at least one randomized witnessed trial
(Level of evidence About the declared use.
Ia, Ib)
B Requires clinical but not randomized trials
(Level of evidence About the declared use.
IIa, IIb, III)
C Requires evidence from reports or opinions of
(Level of evidence expert committees or clinical experience of authorities
IV) recognized.
T It requires the justified support of ethnomedical reports and
(Level of evidence ethnobotanical utilization, technical documentation and
V) scientific, indexed publications or documents endorsed by
a committee of experts, or requires bibliographic references
or expert reports proving that the
Natural active substance in question has had medicinal use
for a minimum period of 30 years prior to the date of
the request, of which at least 15 years in the territory
Central American At the request of the country in which the

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application for registration / registration for traditional use, the authority

regulator will issue an opinion on the sufficiency of the
experience of traditional use of the natural active substance. The
Applicant will present the appropriate documentation in support of their
Opinion request.
 Page 26 of 27

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ANNEX D
(NORMATIVE)
OFFICIAL BOOKS TO ESTABLISH THE SPECIFICATIONS OF
QUALITY AND AS A SOURCE OF CONSULTATION

The official books to use as a source of consultation in the Central American region in
Natural products are the following in all editions, supplements and
volumes:

a) British Herbarium Compendium.

b) Compendium of Monographs, published by the Products Administration Council
Natural Medicines of Canada.
c) British Herbal Pharmacopoeia.
d) Herbal Pharmacopoeia of the United Mexican States.
e) American Herbal Pharmacopoeia.
f) Caribbean Vegetable Pharmacopoeia. TRAMIL Robineau L. editor.
g) European Pharmacopoeia.
h) Japanese Pharmacopoeia.
i) French Pharmacopoeia.
j)
k)Pharmacopoeia of the People's
Ayurvedic Pharmacopoeia and Republic of China.
the Ayurvedic Form of India.
l) Pharmacopoeia / National Form of the United States.
m) Helvetic Pharmacopoeia.
n) German Pharmacopoeia.
o) Italian Pharmacopoeia.
p) Spanish Pharmacopoeia.
q) Monographs of Medicinal Uses of Vegetable Drugs of ESCOP.
r) Monographs of Selected Medicinal Plants of WHO.
s) PDR for Herbal Medicine.
t) National Vademecum of Medicinal Plants (Guatemala).
u) Alonso. JR 2006. Phytomedicine Treaty. Clinical and pharmacological bases. Pp: 690-
695.
v) Vanaclocha, B., Cañigueral, S. editors. 2003 Phytotherapy. Vademecum of prescription.
4th. edition. Masson
w) Other references with internationally recognized scientific basis.

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