Question & AnswerQ&A (FDA Circular No. 2015-11)
The two main identification numbers required are: a) a unique establishment identification number, and b) a unique global product identification number.
A local drug establishment obtains these numbers by joining a global standards organization, which will assign the unique establishment identification number and provide a series of unique global product identification numbers.
Imported drug products may have a unique global product identification number obtained by the overseas manufacturer from a global standards organization in their country or region of origin. The local distributor-importer only needs to apply for a unique establishment identification number.
Both numbers must be indicated by 31 December 2015.
No, the FDA will not accept any application without these identification numbers after 31 December 2015.
By 30 June 2016, the unique global product identification number must be reflected on the labeling materials in the form of a barcode or QR code.
The barcode must include (1) the batch and, if applicable, the lot number, and (2) the expiry date.
These numbers are used to ensure the integrity of the drug supply chain both domestically and globally, consistent with Good Distribution Practices (GDPs).
Yes, the information is stored in the FDA database and shared with relevant government agencies.
It implements the guidelines for FDA Circular No. 2014-011, which concerns the adoption of unique global product identification numbers for drug products.