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Annex B Request for GMP Evidence Evaluation Form

FDA request form for GMP evidence evaluation

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FOR OFFICIAL USE ONLY
DTN
GMP Clearance No.:
(for renewal applications)

REQUEST FOR GMP EVIDENCE EVALUATION FORM

*Indicate which is applicable
􀀻Tick where applicable

[A] APPLICANT INFORMATION
A1. Name of company:

Address:

Telephone No.:

Fax No.:

License-to-Operate No.:

(Enclose photocopy of certificate)
1

A2. Person authorised to submit the application on behalf of the company
Name (*Mr/Ms/Mrs/Mdm/Dr):

*PRC No./Passport No./TIN No./Driver’s License No.:

Designation:

Residential address:

Telephone No.:

Fax No.:

Mobile Phone No.:

Official E-Mail Address:

Preferred contact mode: Email / Fax *
(Please ensure that the relevant details above is entered for your preferred contact mode)

[B] FOREIGN MANUFACTURER INFORMATION
B1. Name of Manufacturer:

Office Address:

Telephone No.:

Fax No.:

B2. Manufacturing Site Address:
Address:

Telephone No:

Fax No.:

[C] PHARMACEUTICAL DOSAGE FORM OF PRODUCTS MANUFACTURED /
ASSEMBLED
Product Type

Injection
Admixtures for intravenous infusion
Reconstituted cytotoxic preparations
Total parenteral nutrition preparations
Implants
Sterile powder for injection
Sterile non injectables liquid preparation
Liquid preparations for inhalation
Sterile semi-solid preparations
Sterile powder for irrigations
Sterile powder for topical application
Intraocular drug delivery systems
Sterile strips
Oral liquid preparations
Tablets for oral administration
Soft Capsules
Hard Capsules
Pills
Powders and granules for oral liquid
preparations
Oral powder and granules
Pastille
External liquid preparations
Ear drops
Nasal solution
Foams
Hemodialysis solution
Non-sterile semi-solid preparations
Non sterile powders for topical applications
Powder for hemodialysis
Powder Preparations for inhalation
Suppositories
Pessaries
Medicated soap bars
Transdermal patches
Medicated gums
Tablet for external administration
Beads
Solution for contact lens
Dry powder inhalers
Medicinal gases
Others (please specify):

Manufacture

Primary
Assembly

Secondary
Assembly

[D] GMP EVIDENCE

D1. Type of GMP evidence:
GMP Certificate (Certificate of GMP Compliance)
WHO Certificate of a Pharmaceutical Product
Manufacturer’s License or Manufacturing Authorization, incorporating the specific
medicinal product(s)/dosage form(s)

D2. GMP evidence issued by:

Authority/Regulatory Agencies

Country

D3. Certificate/License reference no.:

D4. Validity of certificate/license:

[E] APPLICANT DECLARATION
1. I am hereby authorized by the company to make this application.
2. I undertake to pay all service charges related to the GMP evidence evaluation. I
understand that service charges are payable upfront to Food and Drug Administration
(FDA) Philippines and are non-refundable.
3. I undertake to ensure that the medicinal products are manufactured in accordance with
Administrative Order No. 2012-0008, Adoption and Implementation of the
Pharmaceutical Inspection Cooperation Scheme (PIC/S) Guide to Good Manufacturing
Practice for Medicinal Products, or equivalent.
4. I declare that the particulars given in this application are true and that the documents
enclosed are authentic or true copies and undertake to notify the licensing authority
within one week of any change in the particulars submitted in this application.
Name and Signature :

Company stamp :

Date :

Annex No.

LIST OF ANNEXES
Nature of Annex

For Official Use Only
 
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