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    Date: 2022-11-23 15:01:26.758584

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    Date: 2022-11-24 08:46:24.182875

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#2 Inquiry on GMP Clearance for Japanese Veterinary Drugs

Requested from DOH by C. Tumpap at 03:01 PM on Nov 23, 2022.
Purpose: Business purpose
Date of Coverage: 11/23/2022 - 11/23/2022
Tracking no: #DOH-897154818507

Tumpap 03:01 PM, Nov 23, 2022

Hello, 

In the requirements in your website (https://www.fda.gov.ph/wp-content/uploads/2021/03/List-of-Requirements-for-Foreign-GMP-Clearance.pdf), “Annex C (for non-PIC/s countries)”  is listed under "For Foreign GMP Evidence Evaluation". Can you help confirm if Annex C is NOT required for Japanese veterinary products since Japan is a PIC/s country even if Japan joined the PIC/s for human pharmaceuticals, but not for veterinary drugs?

Receiving Officer 08:46 AM, Nov 24, 2022

November 24, 2022

Dear Corelle Maria,

Thank you for your request dated Nov 23, 2022 under Executive Order No. 2 (s. 2016) on Freedom of Information in the Executive Branch, for #2 Inquiry on GMP Clearance for Japanese Veterinary Drugs.

We received your request on Nov 23, 2022 and will respond on or before Dec 14, 2022 03:01:26 PM, in accordance with the Executive Order's implementing rules and regulations.

Should you have any questions regarding your request, kindly contact me using the reply function on the eFOI portal at https://realinagencies11072018-dot-efoi-ph.appspot.com/requests/aglzfmVmb2ktcGhyHQsSB0NvbnRlbnQiEERPSC04OTcxNTQ4MTg1MDcM, for request with ticket number #DOH-897154818507.

Thank you.

Respectfully,

FOI Receiving Officer
FOI Officer

Maker 10:12 AM, Nov 24, 2022

Dear Maria, 

Please be informed that we have endorsed your request to the FOOD AND DRUG ADMINISTRATION(FDA) for action. Kindly await for their response. 

 Thank you.

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