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.




