Marketing authorisation holders in Switzerland

The authorisation holder applies for the authorisation, maintains it, owns the product information, reports adverse reactions to Swissmedic and keeps the product available. Under Art. 10 TPA it must have a registered office in Switzerland.

Yes. The transfer of an authorisation to a new holder is notified to Swissmedic and carries a fee. Product information, packaging material and pharmacovigilance responsibility transfer with it.

The directory is built on the export of the Swissmedic list of authorised medicines. The data date appears in the footer of every page. Swissmedic updates the list monthly, so between two exports authorisations may have been granted, varied or revoked.