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This is to inform all Marketing Authorization Holders (MAHs) of drug products and other concerned stakeholders that FDA Circular (FC) No. 2023-008 entitled “Guidelines on the Publishing of Package Insert and Patient Information Leaflet of Registered Drug Products in the Food and Drug Administration (FDA) Verification Portal System” was published on a newspaper, The Manila Times, on 11 October 2023, thus, shall be effective on 26 October 2023.

In line with the effectivity of the FC, MAHs of all existing registered drug products shall submit the latest approved facsimile/soft copy of Package Insert (PI) and Patient Information Leaflet (PIL) through email at cdrr.label@fda.gov.ph, in accordance to the following respective schedules:

Drug Products Submission Schedule
Monitored Release Status (Chemical/Biological) (including Monitored Release turned Initial status) 26 October 2023- 25 December 2023
Generic Prescription Drug 26 December 2023- 25 June 2024
Biologicals 26 June 2024 – 25 July 2024
Over-the-Counter Drug 26 July 2024 – 25 October 2024
Traditional Medicine/Herbal Medicine/Home Remedy/ Veterinary Drug 26 October 2024 – 25 November 2024

The FDA advises and encourages all stakeholders, healthcare professionals, and the general public to utilize the FDA Verification Portal System to access the list of registered products and the available package inserts and patient information leaflet.
For inquiries or clarification, you may email the Center for Drug Regulation and Research at cdrr.od@fda.gov.ph.

 

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