Email Worksheet

The application form has six parts: 1) General

Information, 2) Establishment Information, 3) SUBJECT:
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 indicated.Required fields will BODY:
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
(not as an image or as an attachment). DON'T attach Printing Instructions
any file to the email request. (Please print the following parts of the worksheet 'Form' if a
For Drug Registration (excluding amendments and c
For Non-Drug Registration (excluding amendments and c
For Licensing (exclusing amendments and c
For All Other

Application Process Overview

 IMPORTANT

READ THIS PAGE CAREFULLY.

Provide information only
when asked for.

ts of the worksheet 'Form' if applicable)

(excluding amendments and compliances): pages 1 and 4.
n (excluding amendments and compliances): pages 1 and 3.
g (exclusing amendments and compliances): pages 1 and 2.
For All Other Applications: page 1 only.
 APPLICATION FORM 5 SOURCES

This is the application form. Without the

appropriate petition or declaration form,
this application may be rejected.
Document Tracking Number APPLICATION FORM STATUS
GENERAL INFORMATION: PROCEED
ESTABLISHMENT INFORMATION:
Description (Optional): PRODUCT INFORMATION:
SUPPORTING INFORMATION:
1 GENERAL INFORMATION PROCEED SOURCES & CLIENTS:
APPLICANT INFORMATION:
1.1 Product Center: Drug

1.2 Authorization: License to Operate

1.3 Type: Renewal

1.4 Primary Activity: Retailer

This form was last edited on 13 October 2016, 10:28 AM.

1.5 Current License 13-0365-19-H3-1
Number:
1.5.1 Expiry Date: 31-Dec-19
Your License will expire in 29 days.

1.7 Are there amendments or variations with

your current authorization? No
AUTOMATIC RENEWAL

Major

Major

Major
2 ESTABLISHMENT INFORMATION
2.1 Name of Establishment
VICTORIANO LUNA MEDICAL CENTER

2.3 Tax Identification Number: 000-863-569-002

2.4 Office Address 2.5.1 Region:
Pharmacy Service Branch, AFP Health Service
Command, V Luna Road, Quezon City

Pharmacy Service Branch, AFP Health Service

Command, V Luna Road, Quezon City

pharmacyserviceafphsc@gmail.

4262111 loc 6428

License to Operate

This is the petition form for establishment licensing by the Food

 PETITION
We categorically declare that all data and information submitted in connection with
amendments, are true, correct, and reflect the total information available.
I/we am/are duly authorized to affirm the following declaration on behalf of the Compan

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

II. The pharmacist and other allied health professionals, upon and during employment in
with any other FDA-regulated establishment (if applicable);

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

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

V. The attached electronic copy of files/documents/information of the LTO application are

prejudicial contents or willful misrepresentation on any of the data therein shall be a grou
against the undersigned and/or the company;

VI. If applying for automatic renewal:

a. Have filed the application, and have paid the complete & appropriate renewal fee be

B. That there are no changes or variations in the establishment since the last renewal o
ownership, change of business name, change of registered pharmacist, change in wareh
change in key personnel;

VII. The products we manufacture, distribute and/or sell are registered or to be registered
responsibility and/or stewardship over the product in case of liability, adverse events, and

VIII. The establishment whether for initial, renewal or automatic renewal, is still subject t
time and undertake to respond and cooperate fully with the FDA with regard to any subse

IX. Non-compliance with the requirements and/or failure to give notice to the FDA of the
other circumstances in relation to the approval of this application is a ground for revocatio
X. Any violation of the above provisions and rules and regulations will automatically be su
License to Operate.

XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720
Food and Drug Administration Act of 2009, other allied laws and their implementing rule

WHEREFORE, the undersigned confirm the truth of our declaration and awareness of the
this application for License to Operate be granted after compliance with the Food and Dru

WAIVER
I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATI
PRIVATE RESOURCES THE AUTHENTICITY OF ALL THE INFOR

ACKNOWLEDGEME
SUBSCRIBED AND SWORN TO BEFORE ME this _______ day of ___________

_______________________________________________________, Philippines, persona

Name and Signature Identification Number

:
1)
:
2)
Known to me and to me known to be the same persons who execute the application form
same is their free and voluntary act and deed. WITNESS MY HAND AND SEAL on the date

Doc. No. : ___________________________

Page No. : ___________________________
Book No. : ___________________________
Series of : ___________________________
 Off-white to beige, semi
CLOPIDOGREL (as BISULFATE) coated tablet with score
plain on the other side
 Off-white to beige, semi
CLOPIDOGREL (as BISULFATE) coated tablet with score
plain on the other side
CLOPIDOGREL (AS BISULFATE) NINBO BEITON
2) Active Pharmaceutical Ingredient; 2) API Manufac
3) Active Pharmaceutical Ingredient; 3) API Manufac
4) Active Pharmaceutical Ingredient; 4) API Manufac
5) Active Pharmaceutical Ingredient; 5) API Manufac
6) Active Pharmaceutical Ingredient; 6) API Manufac
7) Active Pharmaceutical Ingredient; 7) API Manufac
8) Active Pharmaceutical Ingredient; 8) API Manufac
9) Active Pharmaceutical Ingredient; 9) API Manufac
10) Active Pharmaceutical Ingredient; 10) API Manufa
11) Active Pharmaceutical Ingredient; 11) API Manufa
12) Active Pharmaceutical Ingredient; 12) API Manufa
OURCES & CLIENTS
e Food and Drug Administration of the Philippines.
ON
n with this application as well as other submissions in the future including

ompany: VICTORIANO LUNA MEDICAL CENTER

f a PRC registered professional (if applicable) or authorized personnel;

ment in this establishment, is/are not and will not in any way be connected

place of the establishment;

ucts in the event that there is a similar or same name registered with the

tion are the exact duplicate of the hard copy and, any discrepancy,
a ground for disapproval of application and/or the filing of legal action

l fee before expiry date;

newal of LTO specifically but not limited to change of location, change of

n warehouse site, additional supplier and product lines, change in activity,

gistered with FDA prior to distribution or sale, and that we assume primary
nts, and/or other public health & safety issues;

ubject to inspection by FDA’s authorized representatives at any reasonable

y subsequent post-marketing activity;

of the change in business address, business name, ownership, or any

evocation of the License to Operate;
ly be subject to the SUSPENSION/ CANCELLATION/ REVOCATION of the

o. 3720, as amended by Republic Act no. 9711, otherwise known as the

ng rules and regulations.

of the foregoing duties and responsibilities among others, and prays that
and Drug Administration’s requirements.

R
STRATION TO VERIFY THROUGH BOTH GOVERNMENT AND
INFORMATION AND DOCUMENTS SUBMITTED .

GEMENT
____________ 20________ at ______________________________

ersonally appeared the following :

umber Expiry Date of ID Place Issued

30-Dec-99
______________________________
30-Dec-99
______________________________
on form and this petition form, and they acknowledged to me that the
he date and place first above written.
 Provide in this space a description of the
eige, semi biconvex film- product in terms of rheology, thermal, Use this space to explain how the lot
and geometry properties among others, code used on the product label is
with score on one side and as applicable; Indicate if appropriate
her side microbiological cultures present in the correctly interpreted
product
Provide in this space a description of the
product in terms of rheology, thermal, Use this space to explain how the lot
and geometry properties among others, code used on the product label is
as applicable; Indicate if appropriate
microbiological cultures present in the correctly interpreted
product
O BEITONG IMP. & EXP. CO. LTD., INDIA KAMAGONG CHEMTRADE CORP./SAN PEDRO LAGUNA
I Manufacturer, Address Address Address; 2) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 3) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 4) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 5) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 6) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 7) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 8) API Supplier, Address Address Address;
I Manufacturer, Address Address Address; 9) API Supplier, Address Address Address;
PI Manufacturer, Address Address Address; 10) API Supplier, Address Address Address;
PI Manufacturer, Address Address Address; 11) API Supplier, Address Address Address;
PI Manufacturer, Address Address Address; 12) API Supplier, Address Address Address;
 Department of Health
Food and Drug Administration
APPLICATION FORM STATUS: APPLICATION FORM
GENERAL INFORMATION: PRO 1 0 1 0 0 0 0 SOURCES & CLIENTS: 0 1
ESTABLISHMENT INFORMATION: 0 0 0 0 1 Document Tracking Number
PRODUCT INFORMATION: 0 0 0 0 1 0 0
SUPPORTING INFORMATION: 0 1 0 0 0 0 0
APPLICANT INFORMATION: 0 0 0 0 Description (Optional):
PAYMENT INFORMATION: 0 0 0
GENERAL INFORMATION 2 ESTABLISHMENT INFORMATION

1.1 Product Center: Drug 1.4 Primary Activity: Retailer

2.1 Name of Establishment
1.2 Authorization: License to Operate
VICTORIANO LUNA MEDICAL CENTER
1.3 Type: Renewal 1
2.3 Tax Identification Number: 000-863-569-002
2.4 Office Address 2.5.1 Regi 0

1.5 Current License Number: 13-0365-19-H3-1 Pharmacy Service Branch, AFP Health Service Command, V L
1.5.1 Expiry Date: 31-Dec-2019 1

Your License will expire in 29 days. 1

1
1
31-Dec-1899 1
[email protected]
0 1
1 1.7 Are there amendments or variations with 0 1
0 your current authorization? No 0 1

AUTOMATIC RENEWAL 1

0 1
0
1 1
Drug 1 0 HUHS
0 0 Food 0 Device

0
0 0

0 0
0
1 0
0
1 1 0
Type of Amendment: Other Amendments 0 0
Source: Add/ Delete FAL 0 License to Operate FAL 0 0

Page 23 of 42 449969785.xlsx 12/02/2019 03:39:52

 Department of Health
Food and Drug Administration
Source: Change of FAL 0 APPLICATION
Reclassification 0 FORM
FAL 0
Change of Importer/FAL 0 0 Change of Distributor FAL 0 0 0
Product RegistrationFAL 0 Finished Product FAL 0 Php -
License to Operate FAL 0 Raw Material FAL 0
0 Free Sale, CertificateFAL 0 1
Pharmaceutical Produ FAL 0
Export Certificate FAL 0 0
Additional ProductioFAL 0 0 1
1

This is the application form. Without the appropriate

petition or declaration form, this application may be
rejected.

1
1
1
1
1
1 0 1
1
1 0 1
1
1 0 1

1
1
1

Page 24 of 42 449969785.xlsx 12/02/2019 03:39:52

 Department of Health
Food and Drug Administration
APPLICATION FORM 1
1
1 0 1
1
1 0 1
1
1 0 1

Page 25 of 42 449969785.xlsx 12/02/2019 03:39:52

 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 Administration of the Philippine

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 professional (if applicable) or a

II. The pharmacist and other allied health professionals, upon and during employment in this establishment, is/are not and will no

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

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

V. The attached electronic copy of files/documents/information of the LTO application are the exact duplicate of the hard copy an

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 last renewal of LTO specifica

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

VIII. The establishment whether for initial, renewal or automatic renewal, is still subject to inspection by FDA’s authorized represe

IX. Non-compliance
Page 26 of 42 with the requirements and/or failure to give notice to the FDA of the change in business
449969785.xlsx address,03:39:52
12/02/2019 business na
 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 business address, business na

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

XI. I/We make this declaration in full knowledge and awareness of Republic Act No. 3720, as amended by Republic Act no. 9711,

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

WAIVER

I HEREBY GRANT AUTHORITY TO THE FOOD AND DRUG ADMINISTRATION TO VERIFY THE AUTHENTICITY OF ALL THE DOCUMENTS

ACKNOWLEDGEMENT

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

_______________________________________________________, Philippines, personally appeared the following :

Name and Signature Identification Number

1) 1 1 _________________________

2) _________________________

Known to me and to me known to be the same persons who execute the foregoing instrument consisting of 2 pages including th

Doc. No. : _____________________________

Page No. : ____________________________

Book No. : ____________________________

Page 27 of 42 449969785.xlsx 12/02/2019 03:39:52

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

Series of : _____________________________

Page 28 of 42 449969785.xlsx 12/02/2019 03:39:52

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 29 of 42 449969785.xlsx 12/02/2019 03:39:52

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 30 of 42 449969785.xlsx 12/02/2019 03:39:52

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 31 of 42 449969785.xlsx 12/02/2019 03:39:52

 Department of Health
Food and Drug Administration
APPLICATION FORM 1
0 1
1 1
1 1
1 1 1 1

1 1

1 1

1 1

1 1

1 1

1 1

1 1

1 1

1 1

1
1 1
1 1
1 1
1 1
1 1
1 1 1
None 0 None 0

1 1

1 1

1 1
1 1
1 1

Page 32 of 42 449969785.xlsx 12/02/2019 03:39:52

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

1 1

1 1

1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0

1 1

1 1

1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0

1 1

1 1

1 1
1 1
1 1
0 1 0 1
01 1 01 1
None 0 None 0

1 1

1 1

Page 33 of 42 449969785.xlsx 12/02/2019 03:39:52

 Department of Health
Food and Drug Administration
APPLICATION FORM
1 1
1 1
1 1
0 1 0 1
01 1 01 1

Page 34 of 42 449969785.xlsx 12/02/2019 03:39:52

 Department of Health
Food and Drug Administration
APPLICATION FORM
e Philippines.

1.5.1 Expiry Date:

cable) or authorized personnel;

and will not in any way be connected with any other FDA regulated establishment (if applicable);

the Food and Drug Administration or if it rules later that it is misleading;

rd copy and, any discrepancy/ prejudicial contents or wilful misrepresentation on any of the data therein shall be a ground

O specifically but not limited to change of location, change of ownership, change of business name, change of registered pha

selling;

ed representatives at any reasonable time and undertake to respond and cooperate fully with the FDA with regard to any

usiness
Pagename,
35 ofownership,
42 or any other circumstances in relation to the approval of this application is a ground12/02/2019
449969785.xlsx for delisting03:39:52
 Department of Health
Food and Drug Administration
APPLICATION FORM
usiness name, ownership, or any other circumstances in relation to the approval of this application is a ground for delisting

NCELLATION/ REVOCATION of the License to Operate.

no. 9711, otherwise known as the Food and Drug Administration Act of 2009, other allied laws and their implementing ru

bilities among others, and prays that this application for License to Operate be granted after compliance with the Food and

CUMENTS SUBMITTED FROM BOTH GOVERNMENT AND PRIVATE RESOURCES.

______________________________

Date Issued Place Issued

____ ___________ ______________________________

____ ___________ ______________________________

cluding the application form, and they acknowledged to me that the same is their free and voluntary act and deed. WIT

Page 36 of 42 449969785.xlsx 12/02/2019 03:39:52

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 37 of 42 449969785.xlsx 12/02/2019 03:39:52

 Department of Health
Food and Drug Administration
APPLICATION FORM

Page 38 of 42 449969785.xlsx 12/02/2019 03:39:52

 cy
Ser
vice
Bra
VIC nch
LTO TOR
Na
APP IAN , Com
AUT LICA Ome AFP War 000 Iden Prev Dat pan
APPLICATION
GENERAL INFORMAT
DOC Plan Of Con
COMPANY INFORMATION LTO Dat
INFORMATIONAPPLICANT
13- Serv
INFORMATION Pro
of Hea eho - 1 1 tific ious e of y DETAILS
TRA CEN HOR TIO LUN t ce tact Ow LTO Vali e Na Vali ice Clas Cate Capi
duct
Esta Add lth 01; TIN ner 036
use 863 1- atio dity Beg Emp Resi Ret
1-
CK TER IZAT N Add Det No dity Issu me
CDR AR Ablis ress ress ails Add 5- n loye gna sific gory tal
NO0 LTO 1-1 Ser 01; 1-1 - 0 ### 1;1 1;1- 1;1 r tion aile 1
ION TYP hme ed un
R N
E ME ress 19- No atio
nt vice 01 569 1 1- 1 r n
DIC H3-
Co - 1
CPR AL
CEN mm 002 1
GENERAL INFORMATCOMPANY and
INFORMATION PRODUCT INFORMATION
TER , V
#0 AddrE-mai
DOC CENTAUTHAPPLAppl TIN ContaLTO NValidBran GeneProduDosagDosaClassEssenPharm PCPRProduManu Add
Lun
0 CDRRLTO ARN VICT0-Phphar000-01;0
a 13-0### 0 0 0 0 0 0 0 0 ### 1-1 1
Roa
d,
Que
zon
City
MediCDRR AdditPSZ
CosmCCRR ChangCID
DrugCDRR ChanCBN
FoodCFRR ShelfSLF
HousCCRR PCPRPCC
MediCDRR WareWRH
IodizCFRR SourcSAD
Bott CFRR SourSCN
ChanCBN
ChanCKP
LicenLTO PackPDS
NotifNTN
Produ CPR
PromPAD
Clini CTR
OtherOTH 1
0
InitiaINT
ReneRNW
AutoARN MajoMaV
VariaVAR MinoMiV
AmenAMD
CompCOM
Re-I REI OtheOTH
Reapp RAP FinisFIP
Home HSO Raw RAW
Sale SPR ActivACT
Disc DSC ProduPRL
AmenAMJ NothNOF
AmenAMN ReclaRCL
Gener GLE
Free CFS MajoMaV
Pharm PHP Minor
MiV-PA1 to 20
ExporEXP Minor
MiV-PA1 to 20, PH01 to PH06
BranBRN Minor
MiV-N
ProviPPM PCPRPCPR Conversion
ExempCEX
HACCPHCP
MR/N MR
MoniMRE
 DES
AMENDMENT
DEL AMENDMENT
DEL AMENDMENT
DEL CRIP OTH
DES PAYMENT DETAILS Dat
1 ETE 2 ETE 3 ETE TIO ERS Surc Tota
TYP ADD /CH TYP ADD /CH TYP ADD /CH CRIP OTH OR e
N Fee LRF harg
E
Ma E
Ma E
Ma TIO ERS l No. Issu
AN AN AN e
N0 ### ### ### ### 0 ###
ed
V-0 GE V-0 GE V-0 GE

TIN LTO ValidTrade AddTIN LTO ValidRepac AddTIN LTO ValidImpor AddTIN LTO ValidDistr AddTIN LTO Valid
1 1 1-1 1 1 1 1-1 1 1 1 1-1 1 1 1 1-1 1 1 1
 APPLOTHER REQUEST PAYMENT DETAILS
Shelf-StoraPackaSuggeNo. oExpirCPR VRegistrat RegisAmenAmenAmenCerti OtherFee LRF SurchTotalOR NDate Issued
0 0 0 ### 0 ### ### ### ARN MaV-MaV-MaV-0 ### ### ### ### ### ###