Transfer of the marketing authorisation to a new holder ("MAH transfer")

The NIP handles the MAH transfer as a notification (not as a modification). The fact of the transfer is published in the database and on the Product Information. The data is published on the homepage of the Institute. We notify the MAH of the changes through an official marketing authorisation.

Should there be future modifications (i.e. product name changes, Pharmacovigilance system changes etc.) a new variation application is required.