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Email Worksheet

The application form has six parts: 1) General


Information, 2) Establishment Information, 3) Product SUBJECT: SAN JOSE DISTRICT HOSPITAL#IVA
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 BEGIN:LTO;CDRR;SAN JOSE DISTRICT
indicated.Required fields will appear sequentially.To BODY: HOSPITAL#IVA#Retailer#0;RNW#0#0#0#0#0
minimize errors and confusion, it is recommended that #0#0#0#0;2000;20;7200;9220:END
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
any file to the email request. Printing Instructions
(Please print the following parts of the worksheet 'Form'
For Drug Registration (excluding amendment
For Non-Drug Registration (excluding amendment
For Licensing (exclusing amendment
For All

Application Process Overview


IMPORTANT
OSPITAL#IVA

READ THIS PAGE CAREFULLY.


Provide information only
JOSE DISTRICT when asked for.
er#0;RNW#0#0#0#0#0
00;9220:END

of the worksheet 'Form' if applicable)


on (excluding amendments and compliances): pages 1 and 4.
on (excluding amendments and compliances): pages 1 and 3.
ng (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: PROCEED
Description (Optional): PRODUCT INFORMATION: PROCEED
SUPPORTING INFORMATION: PROCEED
1 GENERAL INFORMATION PROCEED SOURCES & CLIENTS: PROCEED
APPLICANT INFORMATION: PROCEED
1.1 Product Center: Drug
ORDER OF PAYMENT
Amount Due: Php 9,220.00
1.2 Authorization: License to Operate
Fee : Php 2,000.00
Legal Research Fee : Php 20.00
1.3 Type: Renewal
Surcharge : Php 7,200.00
OR Number :
1.4 Primary Activity: Retailer
Date Paid:
Computation Valid Until: Date Paid
TURNED INITIAL This form was last edited on 13 October 2016, 10:28 AM.

4A-089A-18-H1-1
PROCEED
31-Dec-18

No
2 ESTABLISHMENT INFORMATION PROCEED
2.1 Name of Establishment
SAN JOSE DISTRICT HOSPITAL

2.3 Tax Identification Number: 001-418-024


2.4 Office Address 2.5.1 Region: IVA
Banay-Banay 1, San Jose 4227 Batangas

6 APPLICAN

The undersigne
requirements a
of the Food an
2.7.0 E-mail Address: sjdhbats_78@yahoo.com Storage Practic
2.7.1 Contact Detail 1 Landline: 0437262354 undersigned ag
2.7.2 Contact Detail 2 Landline: 0437262046 application.
2.7.3 Contact Detail 3 Mobile: 09227667043
6.1 APPROV

PROCEED

Latest phot

6.1.2 Designati
6.1.3 Tax ID Nu
6.1.4.0 Type of
6.1.4.1 ID Num
6.1.4.2 Date Ex
6.2 APPLICA

Latest phot

6.2.2 Designati
6.2.3 Tax ID Nu
6.2.4.0 Type of
6.2.4.1 ID Num
6.2.4.2 Date Ex
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

Professional Regulatory
Commission:0058321
1) REYNALDO CARANDANG OZAETA
Professional Regulatory
Commission:0046721
2) NENETTE GONZALES KATIGBAK
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 PROCEED
PPLICANT INFORMATION PROCEED

undersigned attest to have provided true and complete information in this form, and to provide complete
rements at the time of submission. The undersigned agree to strict compliance with the rules and regulations
e Food and Drug Administration (FDA), including Good Manufacturing Practice (GMP), Good Distribution and
ge Practice (GDSP), Good Pharmacy Practice (GPP), and/or Good Laboratory Practice (GLP). Further, the
rsigned agree to grant authority to the FDA to verify the truthfulness of the information provided with this
cation.

APPROVING AUTHORITY
Signature 6.1.5 Mailing Address
SAN JOSE DISTRICT HOSPITAL,
Banay-Banay 1, San Jose 4227
Batangas
6.1.1.0 Family
atest photo of applicant Name: OZAETA
6.1.1.1 First
REYNALDO
Name(s): 6.1.6.0 E-mail Address:
6.1.1.2 Middle reycozmd@yahoo.com
CARANDANG
Name: 6.1.6.1 Contact Detail 1
Designation: Owner/ General Manager/ President Landline: 0437262230
Tax ID Number: 115-804-318 6.1.6.2 Contact Detail 2
.0 Type of Gov't ID: Professional Regulatory Commission Landline: 0437262319
.1 ID Number: 0058321 6.1.6.3 Contact Detail 3
.2 Date Expiry: 23-Oct-20 Mobile: 09228171023
APPLICANT
Signature 6.2.5 Mailing Address
SAN JOSE DISTRICT HOSPITAL,
Banay-Banay 1, San Jose 4227
Batangas
6.2.2.0 Family
atest photo of applicant Name: KATIGBAK
6.2.2.1 First
NENETTE
Name(s): 6.2.6.0 E-mail Address:
6.2.2.2 Middle sjdhbatangas.pharmacy.dept@gmail.
GONZALES
Name: 6.2.6.1 Contact Detail 1
Designation: Company Pharmacist Landline: 0437262354 loc 132
Tax ID Number: 258-991-381 6.2.6.2 Contact Detail 2
.0 Type of Gov't ID: Professional Regulatory Commission Mobile: 09227667043
.1 ID Number: 0046721 6.2.6.3 Contact Detail 3
.2 Date Expiry: 14-Jun-20 Mobile: 09420261186

e Food and Drug Administration of the Philippines.


ON
n with this application as well as other submissions in the future including

ompany: SAN JOSE DISTRICT HOSPITAL

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

ulatory 23-Oct-20
58321
______________________________
ulatory 14-Jun-20
46721
______________________________
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 1 0 0 0 0 0 SOURCES & CLIENTS: PRO 1 1
ESTABLISHMENT INFORMATION: PRO 1 0 0 1 1 Document Tracking Number
PRODUCT INFORMATION: PRO 1 0 0 0 1 0 0
SUPPORTING INFORMATION: PRO 1 1 0 0 0 0 0
APPLICANT INFORMATION: PRO 1 1 1 1 Description (Optional):
PAYMENT INFORMATION: 1 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
SAN JOSE DISTRICT HOSPITAL
1.3 Type: Renewal 1
2.3 Tax Identification Number: 001-418-024
TURNED INITIAL 2.4 Office Address 2.5.1 RegiIVA

0 Banay-Banay 1, San Jose 4227 Batangas


30-Dec-1899 1

1
1
0
30-Dec-1899 1
2.7.0 E-mail Address: sjdhbats_78@yahoo.com
2.7.1 Contact Detail 1 Landline: 0437262354
0 2.7.2 Contact Detail 2 Landline: 0437262046
0 0 2.7.3 Contact Detail 3 Mobile: 09227667043

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 438416912.xlsx 09/21/2019 10:28:55


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
ORDER OF PAYMENT 1
Amount Due: 9220
Fee : 2000
Legal Research Fee : 20
Surcharge : 7200
OR Number :
This is the application form. Without the appropriate
Date Paid: petition or declaration form, this application may be
Computation Valid Until: Date Paid rejected.
6 APPLICANT INFORMATION

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

6.1 APPROVING AUTHORITY


6.1.5 Mailing Address

Signature

6.1.1.0 Family N OZAETA


SAN JOSE DISTRICT HOSPITAL, Banay-Bana
6.1.1.1 First NamREYNALDO 6.1.6.0 E-mail Address:
reycozmd@yahoo.com
Latest photo of applicant 6.1.1.2 Middle NCARANDANG 6.1.6.1 Contact Detail 1
6.1.2 Designation: Owner/ General Manager/ President Landline: 0437262230
6.1.3 Tax ID Number: 115-804-318 6.1.6.2 Contact Detail 2
6.1.4.0 Type of Gov't ID: Professional Regulatory Commission Landline: 0437262319
6.1.4.1 ID Number: 0058321 6.1.6.3 Contact Detail 3
6.1.4.2 Date Expiry: 44127 Mobile: 09228171023
6.2 APPLICANT
6.2.5 Mailing Address

Signature

6.2.2.0 Family N KATIGBAK


SAN JOSE DISTRICT HOSPITAL, Banay-Bana
6.2.2.1 First NamNENETTE 6.2.6.0 E-mail Address:

Latest photo of applicant


Page 24 of 42 438416912.xlsx 09/21/2019 10:28:55
Department of Health
Food and Drug Administration
APPLICATION FORM
sjdhbatangas.pharmacy.dept@gmail.co
Latest photo of applicant 6.2.2.2 Middle NGONZALES 6.2.6.1 Contact Detail 1
6.2.2 Designation: Company Pharmacist Landline: 0437262354 loc 132
6.2.3 Tax ID Number: 258-991-381 6.2.6.2 Contact Detail 2
6.2.4.0 Type of Gov't ID: Professional Regulatory Commission Mobile: 09227667043
6.2.4.1 ID Number: 0046721 6.2.6.3 Contact Detail 3
6.2.4.2 Date Expiry: 43996 Mobile: 09420261186

Page 25 of 42 438416912.xlsx 09/21/2019 10:28:55


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
438416912.xlsx address,10:28:55
09/21/2019 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) OZAETA REYNALDO _________________________

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. : ____________________________

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

Series of : _____________________________

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Department of Health
Food and Drug Administration
APPLICATION FORM

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Department of Health
Food and Drug Administration
APPLICATION FORM

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Department of Health
Food and Drug Administration
APPLICATION FORM

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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
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1 1
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1 1 1
None 0 None 0

1 1

1 1

1 1
1 1
1 1

Page 32 of 42 438416912.xlsx 09/21/2019 10:28:55


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

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Page 33 of 42 438416912.xlsx 09/21/2019 10:28:55


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 438416912.xlsx 09/21/2019 10:28:55


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

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 ground09/21/2019
438416912.xlsx for delisting10:28:55
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

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Department of Health
Food and Drug Administration
APPLICATION FORM

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Department of Health
Food and Drug Administration
APPLICATION FORM

Page 38 of 42 438416912.xlsx 09/21/2019 10:28:55


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