The reporting obligation according to Art. 35 of the Swiss Ordinance on Medicinal Products (VAM) applies to all marketing authorisation holders. The adaptation of the medicinal product texts takes place after the same has been adapted for the original product. As the approval and publication of a variation is required to include the PRAC recommendations a delay in including the PRAC recommendation may be inevitable for generics.
Handling PRAC Recommendations (Signals) as a Generics Vendor
How do you as a generics suppliers handle PRAC recommendations (signals) if the marketing authorisation holder of the original preparation in Switzerland has not implemented a corresponding change of the medicinal product information, and, for generics, you have to adhere to the original drug product’s Information for Professionals ?