Republic of the Philippines

Department of Health
BUREAU OF FOOD AND DRUGS
Manila
IN THE MATTER OF PETITION OF
__________________________________
TO OPEN A FOOD ESTABLISHMENT
MORE PARTICULARLY AS A :
( ) Manufacturer/Processor
( ) Repacker
( ) Importer/Trader
( ) Exporter
--------------------------------------------------PETITIONER
COMES ON the undersigned petitioner unto the Bureau of Food and Drugs,
Department of Health, Manila, respectfully alleges:
FIRST
- That the petitioner is of legal age, married/single, Filipino citizen and
residing at,____________________________________________________________
SECOND - That he desires to open a food establishment, more particularly
as a ____________________________________________ of food and drug products
be located at _______________________________________ and shall be
known as ________________________________________________,
THIRD
That the said establishment with a capital / investment of
Pph_____________ is owned by ________________________ with postal address,
at_____________________________________________ and with Tel. No._______
FOURTH That the petitioner hereby agrees to change the business name or
corporate name of the establishment in the event that there is a similar or same name
registered with the Bureau of Food and Drugs or if it rules later that it is misleading;
WHEREFORE, the petitioner respectfully prays that he / she be granted License to
Operate said establishment after inspection thereof and after compliance with the Bureau of
Food and drugs requirements, rules and regulations, including but not limited to attached
BFAD - ILD Form No. 6, which is made as an integral part of this Petition.
Manila,Philippines,__________________________________________2009.
Respectfully submitted:
_____________________________
Printed Name of Petitioner
_____________________________
Signature
SUBSCRIBED AND SWORN to me this ___ day of ____________________
2006. Affiant exhibited to me his / her Residence Certificate No. ________________
issued at _______________________________ on _______________, 2009

Doc. no. ________

Book No. _______
Page No. ________
Series of ________

_________________________________
Administering Officer

INFORMATION SHEET
(FOOD MANUFACTURING AND PROCESSING ESTABLISHMENT)
( ) New Establishment
( ) Presently Operating

I.

Name of Owner :
( ) Single Proprietorship
( ) Partnership

( ) Corporation
( ) Association

II. Name of Establishment :

III. (a) Address of the establishment
_____________________________________________________________________________
_____________________________________________________________________________
(b) Postal Address if different from (a) __________________________________________
_____________________________________________________________________________
(c) Telephone Number (s)_____________________________________________________
IV. List of \food and Drugs Products to be manufactured / repacked and or / exported/ imported.
V. List of Equipment and machinery (For Manufacturer and Repacker only)
VI. If a license, state name, and address of licensing firm:
Name: ________________________________________________________
Address: ______________________________________________________
VII. Source(s) of materials to be used:
(a) Local
( ) Yes
( ) No
(b) Imported
( ) Yes
( ) No
Country of Origin____________________
(c) Imported finished product in bulk from the repackaging:
( ) Yes
( ) No
Country of Origin: ______________
VIII. Personnel: List no. of technical employees and their scholastic attainment,
who are directly in manufacturing / repackaging.
IX. Are the products produced or manufactured for export ( ) Yes ( ) No.
or for local domestic computation? ( ) Yes
( ) No. If for export
state name of country to which it is exported
I declared under oath that the foregoing statement composed of two (2) pages are true ,
correct and complete to the best of my knowledge and belief.

Respectfully submitted:

________________________________
Print Name and Sign above

__________________
Title

_________
Date

Republic of the Philippines

Department of Health
FOOD AND DRUG SERVICES
CENTER FOR HEALTH DEVLOPMENT- CARAGA
Butuan City

Name of Establishment:_________________________________________________________
Addres_________________________________________________Tel.#:__________________
Name of Owner/Manager:________________________________________________________
CAPITAL BREAKDOWN:
Equipment and supplies. . . . . . . . . . . . . . . . . . . . . . . . . . . . .
=____________________
Cost of the building/rental . . . . .. . . . . . . . . . . . . . . . . . . . . . . . = ____________________
Purchases . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. .= ___________________
Labels, cartoons, orders, etc. . . . . . . . . . . . . . . . . . . . . . . . . . . = ____________________
Salaries of the Personnel . . . . . . . . . . . . . . . . . . . . . . . . . . . . . = ____________________
Transport Utility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .. . = ___________________
Cash on hand/Book . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . = ____________________
Total Capitalization . . . = _____________________

__________________________________________
Owner/Manager Name & Signature

REPUBLIC OF THE PHILIPPINES ) S.S.

PROVINCE OF ______________________________)

Subscribed
and
sworn
to
before
me
this
______
day
of
_____________________________
at
______________________________________________________________, Philippines. Affiant
exhibited to me his/her Residence Certificate No. _____________________________, issued on
______________________________________________.

_____________________________
NOTARY PUBLIC

Doc. No. _________________

Page No. _________________

Book No. ________________

Series of _________________

Republic of the Philippines

Department of Health
BUREAU OF FOOD AND DRUGS
Alabang Muntinlupa
Metro Manila

INSPECTION CHECKLIST FOR FOOD ESTABLISHMENT

Name of Food Inspectors: 1 ______________________________________________________
2______________________________________________________
Period of Inspection: Time ________ to _______ Day _____ Month ___________ Year ______
Persons Interviewed: 1. _____________________________ Position _____________________
2. _____________________________ Position ____________________

PART-I
1. Name of Establishment: _______________________________________________________
Address: ________________________________________________ Tel.#: _____________
2. Name of Owner/President of Corporation: _________________________________________
3. License to Operate Number _____________________ Issued On: ______________________
Day Month
Year
Date of Last Renewal: _________________________
Day
Month
Year
4. Capital Invested: ______________________________
5. Number of Personnel:

Educational Attainment

a. Production ____________________________
_________________________________
b. Laboratory ____________________________ ________________________________
6. Production Manufactured:
Name of Products

7. Product Flow Chart attached

8. Organizational Chart attached
9. Quality Control Chart Procedure attached
10. List of Production equipment attached
11. List of Quality Control Facilities & Equipment
12. List of Name & Address of the raw supplier attached
13. Detail Description of Manufacturing Processes attached

Brand Name

Yes (
Yes (
Yes (
Yes (
Yes (
Yes (
Yes (

) No ( )
) No ( )
) No ( )
) No ( )
) No ( )
) No ( )
) No ( )

14. Quality Control Enforced in the Working Area attached

15. Volume of Production per product line per 8-hours shift:

Yes ( )

No ( )

16. Areas:
1. Total Land Area: _________________________
2. Total Covered Area: ______________________

Interviewed by:

Received by:

___________________________________
__________________________________
FDRO Inspector

FDRO Inspector

CHECKLIST /REQUIREMENTS FOR REGISTRATION OF FOOD PRODUCTS

A.
B.
C.
D.

Letter of application from manufacturer/exporter/importer

Valid License to Operate (LTO)
Certificate of brand name clearance from BFAD
Product information
a. List of ingredients in decreasing order or proportion
b. Amount and technical specification of ingredients/additives used.
c. Certificate from flavor supplier that the flavor components are recognized as safe
and suitable for human consumption either by the US Flavor Extract
Manufacturers Association, US Food and Drug Administration, International
Organization of Flavor Industry or other reputable Agency.
d. Physical description and specifications of the finished product.

E. Samples of the product and specifications of the finished product. (See attached list of
minimum product samples)
F. Labels & labelling materials to be used for the product.
G. Certificate of analysis. (Include analytical methods used)
H. Method of manufacturer, packing and quality control.
I. Stability data in support of declared Expiry date.
J. Certificate of agreement between the foreign manufacturer/distributor and the
importer/local distributor.
K. Government certificate of clearance and free sale of the product from the responsible
Government authority in the country of origin and duly authenticated by the Philippine
consulate abroad.
L. Evidence of registration for payment. (change slip/Official Receipt)

INITIAL REGISTRATION:
A. For Imported Products:
A. Exclusive distributor (source: direct from manufacturer)
Requirements: Nos. 1,2,4,5,6,7,8,9,10,11,12
B. Non-Exclusive (No currently marketed similar products)
Requirements: Nos. 1,2,4,5,6,10,11,12

C. Non-Exclusive (with currently marketed similar products)

Requirements: Nos. 1,2,5,6,10,11,12
B. For Locally Manufactured products
Requirements: Nos. 1,2,3,4,5,6,7,8,9,12
RENEWAL REGISTRATION (For all products):
A. Letter of application from the manufacturer/exporter/importer.
B. Certificate of product Registration (CPR) of the previous year.
C. Labels and labelling materials used for the products.
D. Samples of the product in its commercial presentation.
E. Renewal Registration Fee.
F. Valid License to operate (LTO)
G. Technical Specification of the Finish Product.

Submit in a transparent sealable plastic bag together with the samples. (For inquiry ask Product
Services division, FOOD Section tel. # 842-45-38

BFAD-RDIFORM6-AEffective October 1, 1994

Republic of the Philippines

DEPARTMENT OF HEALTH
BUREAU OF FOOD AND DRUGS
Civic Drive, Filinvest Corporate City
Alabang, Muntinlupa City
IN THE MATTER OF PETITION
______________________________________________________________
TO OPEN A DRUG/COSMETIC /MEDICAL DEVICE ESTABLISHMENT
MORE PARTICULARY AS A:
( ) Retail Drugstore
( ) Hospital Pharmacy
( ) Retail Outlet for Non-Prescription Drugs
( ) Drug Distributor (Importer, Exporter, Wholesaler)
( ) Medical Device Distributor ( Importer, Exporter, Wholesaler)
( ) Cosmetic Distributor (Importer, Exporter, Wholesaler)
( ) Drug Manufacturer
xx_____________________________________________xx
PETITION
Comes now THE UNDERSIGNED PETITIONER UNTO THE Bureau of Food and Drugs, Department
of Health, Manila, respectfully alleges;
FIRST That the petitioner is of legal age, married/single, Filipino citizen and residing at
______________________________________________________________.
SECOND That the petitioner desires to open a drug/cosmetic & medical device establishments more
particularly ____________ to be located at __________________________ and shall be known as
_________________________________________.
THIRD That the said establishment shall be open for business from ________A.M. to ________P.M.
and shall be under the personal supervision of __________________________________________, a duly
registered pharmacist with Certificate of Registration No. ______________________ issued on
_______________________________.
FOURTH That _______________________________________ is the owner of said establishment
with postal address at ___________________________________________________.
FIFTH That the amount of capital invested for said establishment is ___________________.
SIXTH That the petitioner hereby agrees to change the business name of the establishment in the
event that there is a similar or same registered with the Bureau of food and Drugs or if it rules later it is
misleading.
WHEREFORE, the petitioner respectfully prays that she/he granted License to Operate a drug/cosmetic
& medical device establishment after inspection therefore and after compliance with the Bureau of Food and
Drugs requirements rules and regulations.
Butuan City, Philippines ________________________________________________________.
The undersigned, as owner of the
Establishment, hereby declares under oath
That he conforms to the declaration of the
petitioner pharmacist,
_____________________________________
Owner Name and Signature
Address: _____________________________
Res. Cert. #: __________________________
Issued on_____________________________
At __________________________________

Tel. #: ____________________________

____________________________________________
Printed Name of Pharmacist
___________________________________________
Signature
Res. Cert. #:______________________________
Issued on __________________________________
at ________________________________________
PTR #:____________________________________
Issued on__________________________________
at ______________________________________
Telephone #:________________________________

SUBCRIBED AND SWORN to before me this __________ day of ______________________200____,

affiant exhibit to me his/their Residence Certificate, the date of which are indicated below his/their respective
name(s) on page one hereof.

_________________________________
Administering Officer
Doc. No. _________________
Page No. _________________
Book No. ________________
Series of _________________

Affix P15.00 documentary stamp

INSTRUCTIONS:
1. For single proprietorship, attached Certificate of Registration from the Bureau Of domestic Trade,
for corporation, partnership or other jurisdicial person, attached Certificate of Registration with
the Securities & Exchange commission, together with a copy of Article of incorporation and Bylaws. If the applicant is an alien, the petition must be accompanied by an authenticated copy of the
Certificate of alien Registration.
2. All drugs and cosmetic products, prior to their introduction into the domestic commerce, must first
be
registered with BFAD.
3.

For other requirement, consult any BFAD License Examination or Inspector.

AFFIDAVIT OF UNDERTAKING

I, ______________________________________________________________________________
(Family Name, First Name, Maiden Middle) Owner/Pharmacist with
PRC Registration Number: __________________________ Issued on _______________________
PTR No.: _________________________ Issued on _______________________
Of legal age, single/married and a resident of ___________________________________________
________________________________________________________________________________
(Permanent Home Address)
and owner/pharmacist of ____________________________________________________________
(Name of Company)
located at ________________________________________________________________________
(Address of Company)
after having been sworn in accordance with law, hereby declare:
1. that I am fully aware of the provision of Pharmacy Law, the Foods, Drugs, Devices and
Cosmetic Act, the Generics Act of 1988 and that I am aware of the specific requirements that the
operation of ____________________________________ shall be under my IMMEDIATE
AND PERSONAL SUPERVISION with business hours being from ________________ AM
to _______________ PM;
2. that I agree to change the business name if there is already a validly registered name similar to
business name;
3. that I shall display the approved License to Operate in a conspicuous place of my establishment;
4. that I shall notify BFAD in case of any change(s) in the circumstances of our application for a
license to operate, including but not limited to change(s) of location, change of pharmacist-incharge and change in drug products;
5. and that I, the pharmacist-in-charge, am not and will not be in any way be connected with any
drug or similar establishment/outlet;
WITHNESS WHEREOF, I hereunto affix my signature this ___ day of ________, 2009
_______________________________________
(Signature of Affiant)
Residence Cert. No. ______________________
Issued on:_______________________________
At _____________________________________
SUBSCRIBED AND SWORN TO ME THIS _______ day of __________________, 2009
at ____________________________________________________.
____________________________________
NOTARY PUBLIC
Until December 31, 200______
Doc. no. ________
Book No. _______
Page No. ________
Series of ________

JOINT AFFIDAVIT OF UNDERTAKING

____________________________________PHARMACIST - IN - CHARGE
with PRC Registration No.______________________
issued on____________________________________
PTR No.____________________________________
of legal age, single / married, and a resident of _________________________________________
and _____________________________________________________owner of
___________________________________________________________________________
(drug establishment)
located at ____________________________________________________________________
of legal age and a resident of _____________________________________________________
after having been sworn in accordance with laws, hereby declare;
1) That we are fully aware of the provisions of the Pharmacy Law, the Foods, Drugs and
Devices And Cosmetics Act, the Generics Act of 1980 and that we are aware of the specific
requirements that the operation of______________________________________ shall be
under the IMMEDIATE AND PERSONAL SUPERVISION OF the Pharmacist-in-charge,
the business hours being from _______A..M. to ______ P.M.;
2) That we agree to change the business name if there is already validly registered name similar
to our business name;
3) That we shall display our approved License to Operate in a conspicuous place of our
establishment;
3) And that we shall notify BFAD in case of any change(s) in the circumstances of our
application for a License to Operate, were specifically including but not limited to change(s)
of location, change of pharmacist-in-charge; an change in drug products.
We execute this Joint Affidavit of Undertaking of confirm the truth of our declaration and our
awareness of the foregoing duties and responsibilities among others.
WITNESS HEREOF, we hereunto affix our signatures this ______ day of _______________,
2004.
___________________________________
Owners Name & Signature
Res. Cert. No.________________________
Issued on. ___________________________
at __________________________________

_______________________________________
Pharmacist Name & Signature
Res. Cert. No.__________________________
Issued on _____________________________
at ___________________________________

Subscribed and sworn to me before this _________ day of ___________ at_______________

_____________________________________.
______________________________________
Notary Public

Affix Php15.00 documentary stamp

Republic of the Philippines

Department of Health
BUREAU OF FOOD AND DRUGS
CENTER FOR HEALTH DEVELOPMENT-CARAGA
Butuan City
P H A R M A C I S TS A F F I D A V I T
TO WHOM IT MAY CONCERN :
THIS IS TO CERTIFY THAT ________________________________________________________________
(BOARD REGISTERED NAME)

a duly registered pharmacist with Registration Certificate No. ___________issued on ____________, 200__
with Privilege Tax Receipt No. ________________(PTR) dated _______________, 200__ is the pharmacist
in- charge of ______________________________________located at _______________________________
________________________________________________ with office hours from _____ A.M. ______P.M.
(Attached photocopy of Certificate of registration and 2x2 latest picture)
This certification is further authenticated by the above mentioned pharmacist with signature appears below.
____________________________________
Date

________________________________________
Printed Name of Pharmacist

____________________________________
Printed Name of Owner

_________________________________________
Signature

_____________________________________
Signature

_________________________________________
Address

_______________________________
Address
Owner : ____________________________________
Address : ___________________________________
Res. Cert. No. ___________________
Issued at _______________________
on _______________________
Tel. No. ________________________

Res. Cert. No. ________________________

Issued at ___________________________
on ___________________________
PTR No. ____________________________
Issued at ____________________________
on ___________________________
Tel. No. ____________________________

SUBSCRIBED AND SWORN TO BEFORE ME THIS_____ day of ___________, 200__ Exhibited this/their
Residence Certificate, the date of which are indicated below his/her respective name on page one hereof.
Doc. No. _________________________
Page No. ________________________
Book No. _______________________
Series No. _______________________

___________________________________
NOTARY PUBLIC

15.00 Documentary Stamps

Note: This certification is valid until a written notification from either one of the above
Signatories of any change of pharmacist shall have been filed and duly acknowledge by this office.
In case of any change of pharmacist :
This replace ________________________________________ with, Registration Certificate No. ____________
issued on __________________, 2000 who Resigned on _____________________________, 200____.
_______________________________________
OWNER

JOINT AFFIDAVIT OF UNDERTAKING

____________________________________PHARMACIST - IN - CHARGE
with PRC Registration No.______________________
issued on____________________________________
PTR No.____________________________________
of legal age, single / married, and a resident of _________________________________________
and _____________________________________________________owner of
___________________________________________________________________________
(drug establishment)
located at ____________________________________________________________________
of legal age and a resident of _____________________________________________________
after having been sworn in accordance with laws, hereby declare;
1) That we are fully aware of the provisions of the Pharmacy Law, the Foods, Drugs and
Devices And Cosmetics Act, the Generics Act of 1980 and that we are aware of the specific
requirements that the operation of______________________________________ shall be
under the IMMEDIATE AND PERSONAL SUPERVISION OF the Pharmacist-in-charge,
the business hours being from _______A..M. to ______ P.M.;
2) That we agree to change the business name if there is already validly registered name similar
to our business name;
3) That we shall display our approved License to Operate in a conspicuous place of our
establishment;
3) And that we shall notify BFAD in case of any change(s) in the circumstances of our
application for a License to Operate, were specifically including but not limited to change(s)
of location, change of pharmacist-in-charge; an change in drug products.
We execute this Joint Affidavit of Undertaking of confirm the truth of our declaration and our
awareness of the foregoing duties and responsibilities among others.
WITNESS HEREOF, we hereunto affix our signatures this _______ day of _______________,
2006.
___________________________________
Owners Name & Signature
Res. Cert. No.________________________
Issued on. ___________________________
at __________________________________

_______________________________________
Pharmacist Name & Signature
Res. Cert. No.__________________________
Issued on _____________________________
at ___________________________________

Subscribed and sworn to me before this _________ day of ___________ at_______________

_____________________________________.

Doc. No. _____________

Page No. ____________
Book No. ____________
Series of _____________

______________________________________
Notary Public

Affix Php15.00 documentary stamp

REPUBLIC OF THE PHILIPPINES

DEPARTMENT OF HEALTH

BUREAU OF FOOD AND DRUGS

Alabang, Muntinlupa
Metro Manila

P H A R M A C I S TS

AFFIDAVIT

TO WHOM IT MAY CONCERN :

THIS IS TO CERTIFY THAT ________________________________________________________________
(BOARD REGISTERED NAME)

a duly registered pharmacist with Registration Certificate No. ___________issued on ____________, 2006_
with Privilege Tax Receipt No. ________________(PTR) dated _______________, 2006 is the pharmacist
in- charge of ______________________________________located at _______________________________
________________________________________________ with office hours from _____ A.M. ______P.M.
(Attached photocopy of Certificate of registration and 2x2 latest picture)
This certification is further authenticated by the above mentioned pharmacist with signature appears below.

____________________________________
Date

________________________________________
Printed Name of Pharmacist

____________________________________
Printed Name of Owner

_________________________________________
Signature

_____________________________________
Signature

_________________________________________
Address

_____________________________________
Address

Res. Cert. No. ________________________

Issued at ___________________________
on ___________________________
PTR No. ____________________________
Issued at ____________________________
on ___________________________
Tel. No. ____________________________

Res. Cert. No. _________________________

Issued at: _____________________________
On _________ ___________________
Tel. No. ______________________________

SUBSCRIBED AND SWORN TO BEFORE ME THIS_____ day of ___________, 2006 Exhibited this/their
Residence Certificate, the date of which are indicated below his/her respective name on page one hereof.

Doc. No. _________________________

Page No. ________________________
Book No. _______________________
Series No. _______________________

___________________________________
NOTARY PUBLIC

15.00 Documentary Stamps

Note: This certification is valid until a written notification from either one of the above
Signatories of any change of pharmacist shall have been filed and duly acknowledge by this office.
In case of any change of pharmacist :
This replace ________________________________________ with, Registration Certificate No. ____________
issued on __________________, 200__ who Resigned on _____________________________, 2006.

_______________________________________
OWNER

CHECKLIST OF REQUIREMENTS FOR OPENING OF DRUG/MEDICAL

DEVICE/COSMETIC ESTABLISHMENT
For Pre-application as Manufacturer/Repacker:
_____ 1. Submit Letter of Intent for pre-site inspection (Fee: P500)
_____ 2. Lay out review (scheduled every Monday only)
GENERAL REQUIREMENTS:
_____ 1. Information as to activity (ies) of establishment
_____ 2. Notarized Accomplishment Petition Form/Joint Affidavit of Undertaking
_____ 3. Photocopy of Business Name Registration
a. For single proprietorship, registration from the Department of Trade and Industry (DTI)
b. For corporation/partnership, registration from the Securities & Exchange Commission (SEC) and Articles
of Incorporation.
Note:
a. If the registered address with DTI/SEC is different from the address of the establishment to be
licensed, submit a photocopy of the Business/Mayors Permit
b. If the establishment adopts another business name/style different from the corporation name
submit registration of the business name/style with DTI.
_____ 4. ID Pictures of the Owner / Authorized Representative and Pharmacist (size: 5cm x 5cm.)
_____ 5. Photocopy of Pharmacists Registration Board Certificate / PRC ID and PTR
_____ 6. Photocopy of Certificate of BFAD Seminar on Licensing of Establishment by the Pharmacist.
_____ 7. Photocopy of notarized valid Contract of Lease of the space/building occupied (if the space/bldg. is not
owned)
_____ 8. Photocopy of Financial Statement duly notarized or received by Bureau of Internal Revenue (BIR), if
not available; submit notarized certification of initial capital invested.
_____ 9. Location Plan/Sit (indicate size, location, immediate environment, type or building)
_____ 10. List of products to be manufactured/distributed in generic and brand names (indicate the therapeutic
classification, dosage form and strength)
_____ 11. Duties and responsibilities of the pharmacist (for readers)
_____ 12. Reference Books:
a. USP/NF (latest edition)
b. R.A. 3720, R.A. 6675 R.A. 5921
c. Remingtons Pharmaceutical Sciences (latest edition)
d. Goodman & Gilman Pharmaceutical basis of Therapeutics
e. British Pharmacopoeia
f. Philippine National Drug Formulary
g. Philippine Pharmacopoeia
*For Drug a & b (mandatory) and any reference from c g
*For Medical Devices b and other BFAD regulations pertaining to Medical Devices
*For Cosmetics b, other official monographs, if applicable (e.g. USP, BP) and other BFAD
regulations pertaining to Cosmetics
ADDITIONAL REQUIREMENTS:
A. For manufacturer:
_____ 1. Site Information File (SIF)
B. For Repacker;
_____ 1. Site Information File (SIF)
_____ 2. Notarized valid Contract/Agreement with the manufacturer with stipulation that both the
Manufacturer and Repacker are jointly responsible for the quality of the products
_____ 3. Photocopy of the License to Operate (LTO) of contract manufacturer
C. For Trader:
_____ 1. Notarized valid Contract/Agreement with the manufacturer with stipulation that both the
Manufacturer and Trader are jointly responsible for the quality of the products
_____ 2. Floor plan of office and storage area.
_____ 3. Photocopy of the License to Operate (LTO) of contract manufacturer/speaker.
D. For Importer of Raw Materials / Finished Products in Bulk:
_____ 1. Foreign Agency Agreement duly authenticated by the Territorial Philippine Consulate
_____ 2. Certificate of Status of manufacturer (CGMP Certificate) issued by a Government Health Agency duly
authenticated by the Territorial Philippine Consulate.
FEE: See Schedule of Fees of LTO at the back page