Email Worksheet

The application form has six parts: 1) General

SUBJECT:
Information, 2) Establishment Information, 3) Product
Information, 4) Supporting Information, 5) Sources and
Clients, and 6) Applicant Information. In the worksheet
'Form' (with the red tab) you will see a dashboard where
the different parts are identified. If the part is
appropriately filled up, a green 'PROCEED' will be
BODY:
indicated.Required fields will appear sequentially.To
minimize errors and confusion, it is recommended that a
blank form be used for every application. If the form is
appropriately filled up, the composed body text (in the
green box) will appear.
Be careful to paste the body text completely as text
Printing Instructions
(not as an image or as an attachment). DON'T attach any
(Please print the following p
file to the email request.
For Drug Registra
For Non-Drug Registra
For Licen

Application Process Overview

Mercury Drug#XI

BEGIN:LTO;CDRR;Mercury
Drug#XI#Retailer#CDRR-RXI-DS2122;ARN#0#0#1#0#1####Mercury DrugDavao City Abreeza Mall;3000;30;0;3030:END

IMPORTANT
READ THIS PAGE
CAREFULLY.
Provide information only
when asked for.

rinting Instructions

Please print the following parts of the worksheet 'Form' if applicable)

For Drug Registration (excluding amendments and compliances): pages 1 and 4.
For Non-Drug Registration (excluding amendments and compliances): pages 1 and 3.
For Licensing (exclusing amendments and compliances): pages 1 and 2.
For All Other Applications: page 1 only.

PAGE
.
ormation only
d for.

ages 1 and 4.
ages 1 and 3.
ages 1 and 2.
age 1 only.

APPLICATION F

This is the application form. Witho

appropriate petition or declaration
application may be rejected.

APPLICATION FORM STATU

Document Tracking Number

Description (Optional):
Mercury Drug- Davao City Abreeza Mall

1 GENERAL INFORMATION

PROCEED

1.1 Product Center: Drug

1.2 Authorization: License to Operate
1.3 Type: Renewal
1.4 Primary Activity: Retailer

GENERAL INFORMATION:
ESTABLISHMENT INFORMATION:
PRODUCT INFORMATION:
SUPPORTING INFORMATION:
SOURCES & CLIENTS:
APPLICANT INFORMATION:

ORDER OF PAYMENT
Amount Due: Php

Fee : Php
Legal Research Fee : Php
Surcharge : Php
OR Number : 0717033A
Date Paid: April 13, 20

Computation Valid Until:

30 J

This form was last edited on 29 January 2016, 1

1.5 Current License

CDRR-RXI-DS-2122
Number:
1.5.1 Expiry Date: 30-Jun-16

Your License will expire in 69 days.

1.7 Are there amendments or variations with your

current authorization?

AUTOMATIC RENEWAL

No

PROCEED

2 ESTABLISHMENT INFORMATION PROCEED

2.1 Name of Establishment
Mercury Drug

2.3 Tax Identification Number: 000-388-474-632

2.4 Office Address
2.5.1 Region: XI
Abreeza Mall, J.P. Laurel, Brgy. 20-B, Davao City

2.7.0
2.7.1
2.7.2
2.7.3

E-mail Address:
Contact Detail 1
Contact Detail 2
Contact Detail 3

md.cpag@mercurydrug.com

Landline:
Landline:
Landline:

082-285-0787
082-285-0787
082-285-0787

PROCEED

License to Operate

This is the petition form for establishmen

We categorically declare that all data and information submitted in

amendments, are true, correct, and reflect the total information availab

I/we am/are duly authorized to affirm the following declaration on b

I. The said establishment shall be open for business hours under the su

II. The pharmacist and other allied health professionals, upon and durin
other FDA-regulated establishment (if applicable);

III. The approved and valid License to Operate shall be displayed in a co

IV. To change the business name of the establishment and/or brand nam
Drug Administration, or if the FDA rules later that it is misleading;

V. The attached electronic copy of files/documents/information of the LT

or willful misrepresentation on any of the data therein shall be a ground
company;
VI. If applying for automatic renewal:

a. Have filed the application, and have paid the complete & appropria

B. That there are no changes or variations in the establishment since

change of business name, change of registered pharmacist, change in
personnel;

VII. The products we manufacture, distribute and/or sell are registered o

responsibility and/or stewardship over the product in case of liability, ad

VIII. The establishment whether for initial, renewal or automatic renewa

undertake to respond and cooperate fully with the FDA with regard to an

IX. Non-compliance with the requirements and/or failure to give notice t

circumstances in relation to the approval of this application is a ground f

IX. Non-compliance with the requirements and/or failure to give notice t

circumstances in relation to the approval of this application is a ground f

X. Any violation of the above provisions and rules and regulations will a
Operate.

XI. I/We make this declaration in full knowledge and awareness of Repu
Administration Act of 2009, other allied laws and their implementing rul

WHEREFORE, the undersigned confirm the truth of our declaration and a

application for License to Operate be granted after compliance with the

I HEREBY GRANT AUTHORITY TO THE FOOD AND D

RESOURCES THE AUTHENTICITY

SUBSCRIBED AND SWORN TO BEFORE ME this _______ day

_______________________________________________________, Philippines, pers

Name and Signature

Socia

1) Laida Gonzalvo Fallorina

2) Michelle Yu Monday

Known to me and to me known to be the same persons who execute th

free and voluntary act and deed. WITNESS MY HAND AND SEAL on the d
Doc. No. : _____________________________
Page No. : ____________________________
Book No. : ____________________________

Book No. : ____________________________

Series of : _____________________________

CLOPIDOGREL (as BISULFATE)

CLOPIDOGREL (as BISULFATE)

CLOPIDOGREL (AS BISULFATE)

2) Active Pharmaceutical Ingredient;
3) Active Pharmaceutical Ingredient;
4) Active Pharmaceutical Ingredient;
5) Active Pharmaceutical Ingredient;
6) Active Pharmaceutical Ingredient;
7) Active Pharmaceutical Ingredient;
8) Active Pharmaceutical Ingredient;
9) Active Pharmaceutical Ingredient;

10) Active Pharmaceutical Ingredient;

11) Active Pharmaceutical Ingredient;
12) Active Pharmaceutical Ingredient;

ON FORM

m. Without the
laration form, this
d.

STATUS
ATION: PROCEED
ATION: PROCEED
ATION: PROCEED
ATION: PROCEED
IENTS: PROCEED
ATION: PROCEED

Php

hp
hp
hp

3,030.00

717033A
ril 13, 2016

3,000.00
30.00
-

30 June, 2016

ry 2016, 11:26 AM.

5 SOURCES & CLIENTS

6 APPLICANT INFORMATION

The undersigned attest to have provided true and complete information in this fo
requirements at the time of submission. The undersigned agree to strict complia
Food and Drug Administration (FDA), including Good Manufacturing Practice (GM
(GDSP), Good Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). F
authority to the FDA to verify the truthfulness of the information provided with th

6.1 APPROVING AUTHORITY

Signature

Latest photo of applicant

6.1.2 Designation:
6.1.3 Tax ID Number:
6.1.4.0 Type of Gov't ID:
6.1.4.1 ID Number:
6.1.4.2 Date Expiry:

6.2 APPLICANT

6.1.1.0 Family
Name:
6.1.1.1 First
Name(s):
6.1.1.2 Middle
Name:

Fallorina
Laida
Gonzalvo

Owner/ General Manager/ President

134-769-317
Social Security System
09-0920-7551
N/A
Signature

Latest photo of applicant

6.2.2 Designation:

6.2.2.0 Family
Name:
6.2.2.1 First
Name(s):
6.2.2.2 Middle
Name:

Monday
Michelle
Yu

Company Pharmacist

6.2.3 Tax ID Number:

6.2.4.0 Type of Gov't ID:
6.2.4.1 ID Number:
6.2.4.2 Date Expiry:

229-326-634
Professional Regulatory Commission
49632
29-Jun-16

shment licensing by the Food and Drug Administration of the Philippines.

PETITION

ted in connection with this application as well as other submissions in th

vailable.

n on behalf of the Company:

Mercury Drug

the supervision of a PRC registered professional (if applicable) or authorized

during employment in this establishment, is/are not and will not in any wa

in a conspicuous place of the establishment;

nd name of products in the event that there is a similar or same name regis

the LTO application are the exact duplicate of the hard copy and, any discr
round for disapproval of application and/or the filing of legal action against

propriate renewal fee before expiry date;

since the last renewal of LTO specifically but not limited to change of locat
ange in warehouse site, additional supplier and product lines, change in act

tered or to be registered with FDA prior to distribution or sale, and that we

ity, adverse events, and/or other public health & safety issues;

enewal, is still subject to inspection by FDAs authorized representatives at

d to any subsequent post-marketing activity;

otice to the FDA of the change in business address, business name, owners
ound for revocation of the License to Operate;

will automatically be subject to the SUSPENSION/ CANCELLATION/ REVOCA

Republic Act No. 3720, as amended by Republic Act no. 9711, otherwise k
ing rules and regulations.

and awareness of the foregoing duties and responsibilities among others,

th the Food and Drug Administrations requirements.

WAIVER

AND DRUG ADMINISTRATION TO VERIFY THROUGH BOTH GOVERNMENT AN

NTICITY OF ALL THE INFORMATION AND DOCUMENTS SUBMITTED .

ACKNOWLEDGEMENT

__ day of _________________ 20________ at ______________________________

s, personally appeared the following :

Identification Number

Expiry Date of ID

Social Security System:09-09207551

N/A

Professional Regulatory
Commission:49632

29-Jun-16

___________

ute the application form and this petition form, and they acknowledged to
n the date and place first above written.

Off-white to beige, semi biconvex filmcoated tablet with score on one side and
plain on the other side

Provide in this space a description of the

product in terms of rheology, thermal, and
geometry properties among others, as
applicable; Indicate if appropriate
microbiological cultures present in the

Off-white to beige, semi biconvex filmcoated tablet with score on one side and
plain on the other side

Provide in this space a description of the

product in terms of rheology, thermal, and
geometry properties among others, as
applicable; Indicate if appropriate
microbiological cultures present in the
product

NINBO BEITONG IMP. & EXP. CO. LTD., INDIA

2) API Manufacturer, Address Address Address;
3) API Manufacturer, Address Address Address;
4) API Manufacturer, Address Address Address;
5) API Manufacturer, Address Address Address;
6) API Manufacturer, Address Address Address;
7) API Manufacturer, Address Address Address;
8) API Manufacturer, Address Address Address;
9) API Manufacturer, Address Address Address;

KAMAGONG CHEMT
2) API Supplier, Ad
3) API Supplier, Ad
4) API Supplier, Ad
5) API Supplier, Ad
6) API Supplier, Ad
7) API Supplier, Ad
8) API Supplier, Ad
9) API Supplier, Ad

10) API Manufacturer, Address Address Address;

11) API Manufacturer, Address Address Address;
12) API Manufacturer, Address Address Address;

10) API Supplier, A

11) API Supplier, A
12) API Supplier, A

PROCEED

PROCEED

in this form, and to provide complete

compliance with the rules and regulations of the
tice (GMP), Good Distribution and Storage Practice
e (GLP). Further, the undersigned agree to grant
ed with this application.

nt

6.1.5 Mailing Address

Abreeza Mall, J.P. Laurel, Brgy. 20-B,

Davao City

6.1.6.0 E-mail Address:

md.cpag@mercurydrug.com

6.1.6.1 Contact Detail 1

Landline: 082-285-0787
6.1.6.2 Contact Detail 2
Landline: 082-285-0787
6.1.6.3 Contact Detail 3
Landline: 082-285-0787
6.2.5 Mailing Address
Abreeza Mall, J.P. Laurel, Brgy. 20-B,
Davao City

6.2.6.0 E-mail Address:

md.cpag@mercurydrug.com

6.2.6.1 Contact Detail 1

Landline: 082-285-0787

on

6.2.6.2 Contact Detail 2

Landline: 082-285-0787
6.2.6.3 Contact Detail 3
Landline: 082-285-0787

nes.

s in the future including

horized personnel;

any way be connected with any

e registered with the Food and

y discrepancy, prejudicial contents

gainst the undersigned and/or the

f location, change of ownership,

in activity, change in key

at we assume primary

ves at any reasonable time and

ownership, or any other

EVOCATION of the License to

rwise known as the Food and Drug

thers, and prays that this

NT AND PRIVATE

__

Place Issued

_________________________
Davao City

ed to me that the same is their

the
, and
s

Use this space to explain how the lot code

used on the product label is correctly
interpreted

Use this space to explain how the lot code

used on the product label is correctly
interpreted

G CHEMTRADE CORP./SAN PEDRO LAGUNA

plier, Address Address Address;
plier, Address Address Address;
plier, Address Address Address;
plier, Address Address Address;
plier, Address Address Address;
plier, Address Address Address;
plier, Address Address Address;
plier, Address Address Address;

pplier, Address Address Address;

pplier, Address Address Address;
pplier, Address Address Address;

Department of Health
Food and Drug Administration

APPLICATION
FORM
1 0 1 0 0 0 0 SOURCES & CLIENTS:

APPLICATION FORM STATUS:

GENERAL INFORMATION: PRO
ESTABLISHMENT INFORMATION: PRO
PRODUCT INFORMATION: PRO
SUPPORTING INFORMATION: PRO
APPLICANT INFORMATION: PRO
PAYMENT INFORMATION:
GENERAL INFORMATION

1
1
1
1
1

1.1 Product Center:

Drug

1.2 Authorization:

License to Operate

1
0
1
1

PRO 1

Document Tracking Number

0
0
1

0
0

1
0

0
0
Description (Optional):
Mercury Drug- Davao City Abreeza Mall
2 ESTABLISHMENT INFORMATION
1.4 Primary Activity:
2.1 Name of Establishment

Retailer

Mercury Drug
1.3 Type:

Renewal
2.3 Tax Identification Number:
2.4 Office Address

1.5 Current License Number:

1.5.1 Expiry Date:

CDRR-RXI-DS-2122

Abreeza Mall, J.P. Laurel, Brgy. 20-B, Dav

30-Jun-2016

Your License will expire in 69 days.

1
31-Dec-1899
2.7.0
2.7.1
2.7.2
2.7.3

1 1.7 Are there amendments or variations with your

No
0 current authorization?

E-mail Address:
Contact Detail 1
Contact Detail 2
Contact Detail 3

md.cpag@mer
Landline:
Landline:
Landline:

AUTOMATIC RENEWAL
0
1
0

1
0
1

0
0
0

1
1
Type of Amendment:
Source: Add/ Delete FAL

Page 40 of 80

1
Other Amendments
License to Operate

0
FAL 0

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Department of Health
Food and Drug Administration
Source: Change of BuFAL
Change of Importer/ DFAL
Product Registration FAL
License to Operate FAL

0
0
0
0
0

0
APPLICATION FORM
0 0

FAL
Reclassification
0 Activity: Additional
FAL
FAL
Finished Product
FAL
Raw Material
Free Sale, Certificate FAL
Pharmaceutical Product
FAL
Export Certificate
FAL
FAL
Product Line

ORDER OF PAYMENT
Amount Due:
Fee :
Legal Research Fee :
Surcharge :
OR Number :
Date Paid:
Computation Valid Until:
6 APPLICANT INFORMATION

0
0
0
0
0
0

Php

0
0

3030
3000
30
0

This is the application form. Without the

42551 declaration form, this application may b

The undersigned attest to have provided true and complete information in this form, and to provide com
the time of submission. The undersigned agree to strict compliance with the rules and regulations of the
Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and Storage Pract
Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). Further, the undersigned agree to gran
verify the truthfulness of the information provided with this application.

6.1 APPROVING AUTHORITY

6.1.5 Mailing Addr

Signature
6.1.1.0 Family Na Fallorina
6.1.1.1 First Name(Laida
Latest photo of applicant
6.1.2 Designation:
6.1.3 Tax ID Number:
6.1.4.0 Type of Gov't ID:
6.1.4.1 ID Number:
6.1.4.2 Date Expiry:
6.2 APPLICANT

6.1.1.2 Middle Na Gonzalvo

Owner/ General Manager/ President
134-769-317
Social Security System
09-0920-7551
N/A

Abreeza Mall, J.P. L

6.1.6.0 E-mail Add
md.cpag@mercury
6.1.6.1 Contact De
Landline:
6.1.6.2 Contact De
Landline:
6.1.6.3 Contact De
Landline:

6.2.5 Mailing Addr

Signature
6.2.2.0 Family Na Monday
6.2.2.1 First Name(Michelle

Abreeza Mall, J.P. L

6.2.6.0 E-mail Add

Latest photo of applicant

Page 41 of 80

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Department of Health
Food and Drug Administration
Latest photo of applicant
6.2.2 Designation:
6.2.3 Tax ID Number:
6.2.4.0 Type of Gov't ID:
6.2.4.1 ID Number:
6.2.4.2 Date Expiry:

Page 42 of 80

APPLICATION
FORM
6.2.2.2 Middle Na Yu
Company Pharmacist
229-326-634
Professional Regulatory Commission

315387420.xlsx

md.cpag@mercury
6.2.6.1 Contact De
Landline:
6.2.6.2 Contact De
Landline:
49632 6.2.6.3 Contact De
42550 Landline:

04/22/2016 07:52:32

Department of Health
Food and Drug Administration
License to Operate

APPLICATION FORM

This form is the second page of a two-page application form for licensing by the Food and Drug Admi

PETITION

I/we am/are duly authorized to affirm the following declaration on behalf of the Company:

I. The said establishment shall be open for business hours under the supervision of PRC registered profe

II. The pharmacist and other allied health professionals, upon and during employment in this establishm

III. The approved and valid License to Operate shall be displayed in a conspicuous place of the establish

IV. To change the business name of the establishment in the event that there is a similar or same name

V. The attached electronic copy of files/documents/information of the LTO application are the exact dupli
VI. If applying for automatic renewal:
a. Have filed the application before expiry date;
b. Have paid the renewal fee prior its expiry date;

c. That there are no unapproved changes or variations whatsoever in the establishment since the las

VII. The products we manufacture, distribute or sell are registered or to be registered with FDA prior to d

VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by

IX. Non-compliance
with the requirements315387420.xlsx
and/or failure to give notice to the FDA
of the change
in busin
Page
43 of 80
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Department of Health
Food and Drug Administration

APPLICATION FORM

IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the change in busin

X. Any violation of the above provisions and rules and regulations will automatically be subject to the SU

XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720, as amended b

WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the foregoing duties

WAIVER

I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATION TO VERIFY THE AUTHENTICITY O
ACKNOWLEDGEMENT

SUBSCRIBED AND SWORN TO BEFORE ME this _______ day of _________________ 20__

_______________________________________________________, Philippines, personally appeared the following :
Name and Signature

1) Fallorina Laida

2)

Known to me and to me known to be the same persons who execute the foregoing instrument consistin

Doc. No. : _____________________________

Page No. : ____________________________
Book No. : ____________________________
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Department of Health
Food and Drug Administration

APPLICATION FORM

Book No. : ____________________________

Series of : _____________________________

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Food and Drug Administration

APPLICATION FORM

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Food and Drug Administration

APPLICATION FORM

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Food and Drug Administration

APPLICATION FORM

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Food and Drug Administration

APPLICATION FORM

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Food and Drug Administration

APPLICATION FORM

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Department of Health
Food and Drug Administration

APPLICATION FORM

0
1
1

za Mall
1

Retailer
1

000-388-474-632
2.5.1 RegioXI
1

0-B, Davao City

1
1
1
1
1
1

g@mercurydrug.com
e:
082-285-0787
e:
082-285-0787
e:
082-285-0787

1
1
1

1
1

Drug
Food

0
0

1
1
1
1
1
1

HUHS
Device

None

0
1

0
0

1
0
0
0
0

Page 51 of 80

1
1
1

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Department of Health
Food and Drug Administration
0
0
Php

APPLICATION FORM00 1
None

1
1
0

1
1

hout the appropriate petition or

n may be rejected.

1
1
1
1

0
01
None

1
0
1

de complete requirements at
s of the Food and Drug
ge Practice (GDSP), Good
to grant authority to the FDA to

ng Address

1
1
1
1

0
01

all, J.P. Laurel, Brgy. 20-B, Davao

mail Address:
mercurydrug.com
ntact Detail 1
082-285-0787
ntact Detail 2
082-285-0787
ntact Detail 3
082-285-0787

None

1
0
1

ng Address

1
1
1
1

0
01
None

1
0
1

all, J.P. Laurel, Brgy. 20-B, Davao

mail Address:

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Department of Health
Food and Drug Administration

mercurydrug.com
ntact Detail 1
082-285-0787
ntact Detail 2
082-285-0787
ntact Detail 3
082-285-0787

Page 53 of 80

APPLICATION FORM

0
01

315387420.xlsx

1
1
1
1
1

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Department of Health
Food and Drug Administration

APPLICATION FORM

ug Administration of the Philippines.

1.5.1 Expiry Date:

ed professional (if applicable) or authorized personnel;

ablishment, is/are not and will not in any way be connected with any other FDA regulated establishment (if a

stablishment;

e name registered with the Food and Drug Administration or if it rules later that it is misleading;

ct duplicate of the hard copy and, any discrepancy/ prejudicial contents or wilful misrepresentation on any o

e the last renewal of LTO specifically but not limited to change of location, change of ownership, change of bu

rior to distribiution or selling;

tion by FDAs authorized representatives at any reasonable time and undertake to respond and cooperate fu

in business
business name, ownership,
or any other circumstances in relation
to the approval
of thi
Page 54 address,
of 80
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Department of Health
Food and Drug Administration

APPLICATION FORM

in business address, business name, ownership, or any other circumstances in relation to the approval of thi

o the SUSPENSION/ CANCELLATION/ REVOCATION of the License to Operate.

ended by Republic Act no. 9711, otherwise known as the Food and Drug Administration Act of 2009, other a

g duties and responsibilities among others, and prays that this application for License to Operate be granted

TICITY OF ALL THE DOCUMENTS SUBMITTED FROM BOTH GOVERNMENT AND PRIVATE RESOURCES.

___ 20________ at ______________________________

owing :
Identification Number

Date Issued

Place Issued

_________________________

___________

__________________

_________________________

___________

__________________

consisting of 2 pages including the application form, and they acknowledged to me that the same is their fre

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Department of Health
Food and Drug Administration

APPLICATION FORM

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Food and Drug Administration

APPLICATION FORM

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Food and Drug Administration

APPLICATION FORM

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Food and Drug Administration

APPLICATION FORM

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Food and Drug Administration

APPLICATION FORM

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Food and Drug Administration

APPLICATION FORM

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Department of Health
Food and Drug Administration
1
APPLICATION FORM
1
1
1
1

1
1
1
1
1
1
1
1
None

1
0
1

1
1
1

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Department of Health
Food and Drug Administration
0
1
APPLICATION
FORM
01
1
None

0
1

1
1
1
1

0
01
None

1
0
1

1
1
1
1

0
01
None

1
0
1

1
1
1
1

0
01
None

1
0
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Department of Health
Food and Drug Administration

APPLICATION FORM

0
01

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Department of Health
Food and Drug Administration

APPLICATION FORM

hment (if applicable);

n on any of the data therein shall be a ground for disapproval of

hange of business name, change of registered pharmacist, change

ooperate fully with the FDA with regard to any subsequent post-ma

roval
of this
is a ground for delisting
of the License to
Page
65 application
of 80
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Department of Health
Food and Drug Administration

APPLICATION FORM

roval of this application is a ground for delisting of the License to

09, other allied laws and their implementing rules and regulations

be granted after compliance with the Food and Drug Administrati

S.

ssued

_______________________

_______________________

is their free and voluntary act and deed. WITNESS MY HAND AND

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APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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APPLICATION FORM

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