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List of Requirements for Foreign GMP Clearance

FDA list of requirements for foreign GMP clearance

Your Browser Doesn't Support Canvas. Showing the Text Content of the PDF Instead: ANNEX E
AFFIDAVIT OF UNDERTAKING
REPUBLIC OF THE PHILIPPINES
PROVINCE OF
MUNICIPALITY OF

I,

of legal age, single/married

residing at
, and authorized representative of
, a registered drug establishment of
The

Food

and

Drug

Administration

Philippines

located

at

, with
LTO Number

and LTO validity

_, having been

Sworn in accordance with law, hereby declare:
1) that I have communicated with the foreign drug manufacturer with the business
name

located at

,
and the said foreign drug manufacturer allows the FDA Philippines to conduct inspection on
their site prior to issuance of GMP clearance.
2) that I am are fully aware of the provisions that I shall arrange and pay the cost of
foreign drug manufacturer GMP inspect including relevant inspect fee travel and
accommodation costs within 15 days from the receipt of notice from FDA but not later than
three (3) months before the scheduled inspect date.
3) that I shall pay services of translator during the conduct of inspection, as needed;

1

4) that I shall notify FDA in case of any change(s) in the circumstances of the
scheduled foreign drug manufacturer inspection not later than two weeks from the scheduled
inspection.
5) and that I fully understand that the FDA may disapprove the issuance of the GMP
clearance foreign drug manufacturer where evidence exist that the foreign drug manufacturer
does not meet the acceptable standards.

I execute this Affidavit of Undertaking to confirm the truth of our declaration and my
awareness of the foregoing duties and responsibilities among others.

IN WITNESS WHEREOF, I hereunto affix my signature this
,

20

,

in the

day of

Municipality

, Province of

of

, Philippines.

(Signature of Owner/ Company Pharmacist)
Res. Cert. No.
Issued on
at

Subscribed and sworn to before me this

day of
.

Notary Public
Until December 31,

at
 
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