Republic of the Philippines

Department of Health
FOOD AND DRUG ADMINISTRATION

CENTER FOR DRUG REGULATION AND RESEARCH

LIST OF REQUIREMENTS FOR FOREIGN GMP CLEARANCE

A. For Foreign GMP Evidence Evaluation

1) Letter of Request
2) GMP Evidence
3) Annex B
4) Annex C (for non-PIC/s countries)
5) Annex E
6) Assessment Slip

B. For Foreign GMP Inspection (if disapproved from desktop evaluation)

1) Letter of Request
2) Annex C (where applicable)
3) Annex D
4) Notice of Inspection
5) Assessment Slip

C. For Renewal of GMP Clearance

1) Letter of Request
2) GMP Evidence
3) Annex B
4) Annex C (for non-PIC/s countries)
5) Annex E
6) Copy of GMP Clearance
7) Assessment Slip

D. Re-issuance of GMP Clearance

1) Letter of Request
2) Copy of GMP Clearance
3) Assessment Slip

Notes:
All documentary requirements must be in PDF format to be submitted to
PAIR
Existing image file format shall be followed
A hard copy of the letter of request is required

Civic Drive, Filinvest City, Alabang 1781 Muntinlupa, Philippines

Trunk Line +63 2 857 1900 Fax +63 2 807 0751
Website: www.fda.gov.ph Email: info@fda.gov.ph