Toll Manufacturing Fda Requirements: Checklists and Forms

TOLL MANUFACTURING
FDA REQUIREMENTS
Checklists and Forms
COSMETICS
Center for Cosmetics Regulation and Research
(CCRR)
MEDICAL DEVICES
Center for Device Regulation, Radiation Health, and Research
(CDRRHR)
CHECKLIST OF REQUIREMENTS FOR OPENING AN ESTABLISHMENT
AS MEDICAL DEVICE IMPORTER/ WHOLESALER/EXPORTER
GENERAL REQUIREMENTS
1.) Notarized Application Form and Joint Affidavit of Undertaking
2.) Notarized Electronic Copy (E-copy) Affidavit
3.) List of Medical Devices to be Imported/Distributed
4.) Photocopy of the Pharmacists Board Registration Certificate, PRC-ID, valid
PTR, Duties and Responsibilities, Certificate of Attendance of
Owner/Pharmacist to an FDA/BFAD Seminar on Licensing of
Drug/Medical Device Establishments and Outlets
5.) Location Plan and Floor Plan (office and storage room/warehouse) with
dimensions
6.) Photocopy of the Business Name Registration
a.) If single proprietorship, registration from the Department of Trade and
Industry
b.) If corporation/partnership, registration from the Securities and Exchange
Commission (SEC) and Articles of Incorporation
7.) ID pictures of the Owner/Authorized Representative and Pharmacist (not
computer generated)
8.) Photocopy of Notarized Contract of Lease for the space of the office and
storage to be occupied or any proof of ownership if it is owned by the
applicant.
ADDITIONAL REQUIREMENTS
A. If IMPORTER:
1.) Foreign Agency Agreement with each supplier/source duly
authenticated by the Territorial Philippine Consulate
2.) Certificate of Registration of the Manufacturer and its conformity with
GMP issued by a Government Health Authority or valid ISO Certification
for Medical Device. Should be duly authenticated by the Territorial
Philippine Consulate.
B. If WHOLESALER:
1.) Notarized valid Contract/Agreement with each FDA (BFAD) licensed
supplier/manufacturer
2.) Copy of the License to Operate (LTO) of the contracted
manufacturer/supplier
3.) Copy of the Certificate of the Product Registration to be distributed
C. If EXPORTER:
1.) Notarized valid Contract/Agreement with each FDA (BFAD) licensed
supplier/manufacturer
2.) Copy of the License to Operate (LTO) of the contracted
manufacturer/supplier
3.) Copy of the Certificate of the Product Registration to be distributed
NOTE:
In addition to the hard copy of the above-mentioned standard requirements, the
client shall also submit an electronic/scanned copy (in PDF searchable format at
least 300dpi) on a DVD-R of the application
The above-stated requirements shall be properly labeled with table of contents
indicating the number of pages, divider with ear tags, and place in a White Data
Folder.
CHECKLIST OF REQUIREMENTS FOR OPENING AN ESTABLISHMENT
AS MEDICAL DEVICE MANUFACTURER/TRADER/RE-PACKER
GENERAL REQUIREMENTS:
1. Notarized Accomplished Petition Form/Joint Affidavit of Undertaking;
2. Photocopy of Business Name Registration;
a) For single proprietorship, registration from the Department of Trade &
Industry (DTI)
b) For corporation/partnership, registration from 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.
3. ID pictures of the Owner/Authorized Representative and Pharmacist (not
computer generated);
4. Photocopy of Pharmacists Registration Board Certificate/PRC ID and PTR;
5. Photocopy of Certificate of BFAD Seminar on Licensing of Establishment by the
Pharmacist;
6. Photocopy of notarized valid Contract of Lease of the space/building occupied
(if the Space /bldg. is not owned)
7. Photocopy of Financial Statement duly notarized or received by Bureau of
Internal Revenue (BIR), if not available, submit notarized certification of initial
capital invested;
8. Location Plan/Site (indicate size, location, immediate environment, type of
building);
9. List of products to be manufactured/distributed in generic and brand names;
10. Duties and responsibilities of the pharmacist.
ADDITIONAL REQUIREMENTS:
A. For Manufacturer:
a. Site Information File (SIF)
B. For Re-packer:
a. Site Information File (SIF)
b. Notarized valid Contract/Agreement with the Manufacturer with
stipulation that both the Manufacturer and Re-packer are jointly responsible
for the quality of the products.
c. Photocopy of the License to Operate of contract manufacturer
C. For Trader:
a. Notarized valid Contract/Agreement with the Manufacturer with
stipulation that both
b. the Manufacturer and Re-packer are jointly responsible for the quality of the
products.
c. Floor plan of office and storage area
d. Photocopy of the License to Operate of contract manufacturer/repacker
D. For Importer of Raw Materials/Finished Products in Bulk:

a. Foreign Agency Agreement duly authenticated by the Territorial Philippine
Consulate
b. Certificate of Status of Manufacturer (CGMP Certificate) issued by a
Government
c. Health Agency duly authenticated by the Territorial Philippine Consulate.
JOINT AFFIDAVIT OF UNDERTAKING
(sample)
JOINT AFFIDAVIT OF UNDERTAKING

______________________________ PHARMACIST-IN-CHARGE
(PRC Registered Name) With PRC Registration No._______________
Issued on__________________________
PTR NO. ___________________________
We ______________________________ and _________________________ of legal age,

single/married, and a residents of __________________________________ owners
of____________________________________________________________________________
(Medical Device Establishment)
located at _______________________________________________________________after
having been sworn in accordance with law, hereby declare:
FIRST - That we are fully aware of the provisions of the Pharmacy

Law, the Foods, Drugs, Devices, and Cosmetics Act, the Generics
Act of 1988, 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 _______AM to
________ PM;
SECOND that we agree to change the business name if there is

already a validly registered name similar to our business name;
THIRD that we shall display our approved License to Operate

(LTO) in a conspicuous place of our establishments;
FOURTH - that we shall notify FDA 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 ownership,
change of pharmacist-in-charge, and change in medical device
products;
FIFTH and that I, the pharmacist-in-charge, am not and will not

be in any way connected with any drug or similar
establishment/outlet;
We execute this Joint Affidavit of Undertaking to confirm the truth of our declaration
and our awareness of the fore going duties and responsibilities among others.
IN WITNESS WHEREOF, we hereunto affix our signature this _________________day

of _____________ 20 ______..
__________________________________ _______________________________
OWNER PHARMACIST
Res. Cert. No. ______________________ Res. Cert. No. ________________________
Issued on __________________________ Issued on ___________________________
at _______________________________ at _________________________________
SUBSCRIBED AND SWORN TO ME THIS _____________ day of _______________20

_______ in ________________________.
NOTARY PUBLIC

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TOLL MANUFACTURING

D. For Importer of Raw Materials/Finished Products in Bulk:

JOINT AFFIDAVIT OF UNDERTAKING

We ______ and _ of legal age,

FIRST - That we are fully aware of the provisions of the Pharmacy

SECOND that we agree to change the business name if there is

THIRD that we shall display our approved License to Operate

FOURTH - that we shall notify FDA in case of any change(s) in the

FIFTH and that I, the pharmacist-in-charge, am not and will not

IN WITNESS WHEREOF, we hereunto affix our signature this _________________day

SUBSCRIBED AND SWORN TO ME THIS _ day of ___20

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