Philippines: The Philippines FDA Amended FDA Circular No. 2021-025 Entitled, “Guidelines for Application of Authorizations at the Food and Drug Administration in Light of the Extended State of Public Health Emergency”
The Philippines FDA has issued an amendment to FDA Circular No. 2021-025, entitled “Guidelines for Application of Authorizations at the Food and Drug Administration in Light of the Extended State of Public Health Emergency”. The amendment is focused on extending further the validity of existing FDA-issued authorizations, such as:
- Licenses to Operate;
- Certificates of Product Registration / Certificate of Product Notification;
- Local Good Manufacturing Practice Certificate;
- Certificate of GMP Compliance for Foreign Drug Manufacturer;
- Certificate of Compliance for x-rat facilities under the One-Stop Shop Licensing System of the Department of Health;
- Certificates of Registration for Magnetic Resonance Imaging (MRI) facilities;
- Special certification for COVID-19 test kits.
Those existing FDA-issued authorizations with validity expiring on January 01 2022 to December 31 2022 will have an additional 4 (four) months validity from the original date of expiration of the authorizations.
This automatic extension shall be applicable only if a complete application for renewal of the said authorizations have been filed with and duly acknowledged by the FDA within the given extension period, following the provision of Section IV. A.2. Renewal Application of FC 2021-025.
As thus amended, all other provisions stipulated in FDA Circular No. 2021-025 dated 09 December 2021, not affected by this amendment shall remain in full force and effect. The FDA circular No. 2021-025-A shall take effect immediately.
Please refer to this link for full details of the amendment.