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 [email protected], 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 [email protected].