New «transitional arrangement» for Marketing Authorisation transfers

What changes to the transfer of Marketing Authorisations process are related to the new HMV4 [Therapeutic Products Ordinance Package IV]?

Previously, when a Marketing Authorisation was transferred, only products bearing the name of the new Marketing Authorisation holder (MAH) (either through new packaging or through the «transitional agreement») were allowed to be marketed from the decree date.

This has partly changed: the packaging of the previous MAH may still be used for a maximum of 1 year. However, since the revised Therapeutic Products Act came into force, stickers bearing the new MAH
(= transitional agreement) have to be affixed to the outer packaging, on top of «MA Hlr./Zul-Inh./ l’AMM», only for those batches which were released by the new Marketing Authorisation Holder after the decree. Stock, already released by the previous MAH for the Swiss market, at the time of the transfer of authorisation, may remain on the market until the end of its shelf life and be sold in the regular way.

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Dr. Katharina Oehler
Scientific and Managing Director

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