Here’s the scenario:
A large multi-national manufactures and packages pharmaceutical finished goods. One presentation of these finished goods are sold in the US through a Partner (co-marketing arrangement). The Artwork and GTIN (NDC) of the product is that of the Partner. However the manufacturing authorization holder (MAH) is the large multi-national brand owner. With Serialization according to the DSCSA, should the GTIN remain that of the Partner? Or, would it need to revert to the MAH?
My belief is that it would not change – remain that of the Partner. Curious if you have come across this and if so, what approach you would take.
If the Global Trade Item Number (GTIN) is constructed using the US National Drug Code (NDC) it will include the labeler code associated with the NDC.
It should not matter which entity’s identity is used and may vary depending on the trade agreement between the application holder and the marketing entity. The Drug Supply Chain Security Act (DSCSA) does not require a GTIN and the 2010 FDA guidance on standardized numeric identifier (SNI) does not require a GTIN. Notwithstanding the GTIN is widely used, it is not required by the FDA or DSCSA law.
The package must also include a printed 10-digit 3-segment NDC number sequence and a linear machine readable symbol containing the NDC, which may optionally be a universal product code (UPC) symbol encoded with a 12-digit GTIN containing the NDC).
The GTIN is simply a globally unique number used to reference a trade item. The global company prefix (GCP) portion of the GTIN is associated with the brand owner. The GTIN is not governed by the FDA or healthcare regulators.
Who holds the NDA? I feel this is a very short discussion because the NDA drivers the NDC, the UPC, and the GTIN derived from that NDC. Also, consider your customers... They are used to scanning the current linear embedded with the previous GTIN. Goal should be to conserve that UPC to minimize wholesaler/dispenser impact.