FDA Guidelines on Unique Global Product IDs for Drugs

All drug product applicants and holders must obtain:
- A unique establishment identification number.
- A unique global product identification number.

Both the establishment and product identification numbers are obtained by joining a recognized global standards organization.
Upon joining, local drug establishments receive their unique establishment identification number and a series of unique global product identification numbers for their products.
Imported drug products must have the unique global product identification number assigned by the overseas manufacturer, obtained through a global standards organization in their country or region.
Local importers/distributors are required only to apply for the unique establishment identification number.

Unique global product identification numbers correspond to stock keeping units (SKUs).

By December 31, 2015, both unique establishment and product identification numbers must be indicated in application forms or other application systems.
FDA will not accept any application lacking these numbers.
Both numbers will be stored in the FDA database, including related establishment and product information.
Information will be shared with relevant government agencies.

By June 30, 2016, the unique global product identification number must be printed on product labeling materials in barcode or QR Code format.
Barcodes or QR Codes must include:
- Batch number and, if applicable, lot number.
- Expiry date.

The use of these unique numbers aligns with Good Distribution Practices (GDPs) enforced by the FDA.
These identifiers serve to ensure the integrity and traceability of the drug supply chain, both domestically and internationally.

Issued under the authority of the Secretary of Health and the Acting Director General of the FDA.
Compliance is mandatory for all applicable drug establishments and applicants.

For strict compliance and information dissemination.