Mandatory Global Product ID for FDA Products

Promote accountability of regulated establishments over their registered products.
Mandate the use of a Global Trade Item Number (GTIN) or equivalent unique global product identification number for all products seeking FDA registration.

Applies to all FDA-regulated products and establishments within the Philippines.

The FDA does not issue the unique global product identification numbers; establishments must obtain these independently.
Establishments receive a unique establishment identification number.
Each product is assigned a unique product identification number (GTIN).
Product identification numbers are permanently linked to the corresponding establishment and product and do not expire.
Manufacturing batches or lots may have separate unique numbers assigned by establishments but are distinct from product identification numbers.
Identification numbers can be represented as barcodes, QR codes, or equivalent graphics.
Product packaging, labels, and containers must visibly display the identification number and/or its equivalent graphic for both unaided consumer verification and electronic scanning.

Establishment authorization applications must include the unique establishment identification number.
Product authorization applications must include the GTIN.
No supporting documents are required to be submitted for identification numbers as part of the authorization process.
The FDA will verify provided identification numbers via a synchronized global data network.
Failure to provide a verifiable GTIN is sufficient cause for application denial.

Any existing regulations or provisions inconsistent with the Circular are repealed or modified accordingly.

If any provision of the Circular is declared invalid by a court or tribunal, the remaining provisions shall continue to be in effect.