When transferring marketing authorisations, the Information for Healthcare Professionals and Patient Information need to be transferred from the previous to the new Marketing Authorisation Holder within the Medicinal Product Publication Platform (AIPS) as follows: (1) The old/previous Marketing Authorisation Holder deregisters its product on the AIPS platform (deregistration date and date with the longest expiry date. The respective Healthcare Professionals and Patient Information are published on the AIPS until the longest expiry date has lapsed). (2)The new Marketing Authorisation Holder launches the product using the function „Upload new text in correspondence language“, enters the product’s metadata and selects the old Marketing Authorisation Holder in the field „taken over from“. (3) The launching of the Information for Healthcare Professionals and Patient Information and the other checks are executed according to an established format.
Dr. Katharina Oehler
Scientific and Managing Director
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