Marketing Authorisation Transfers

Marketing Authorisation Transfers, also referred to as a change of ownership application, is a procedure required when a medicinal product licence is transferred from one company to another.  This can be between separate commercial entities, a company formed due to a merger of previous Marketing Authorisation (MA) holders, or a subsidiary within the existing MA holder company.

MA transfer applications are a frequent lifecycle management activity and can be performed for all types of products (Medicinal, Drug:Device combinations, Medical Devices) licensed via different procedural routes including:

Marketing Authorisation Transfers
  • Centralised procedures (CAP)

  • National licences in Decentralised procedures (DCP)/Multiple Recognition Procedures (MRP)

  • Standalone national licences

For MAs authorised via DCP or MRP routes, the licences in each country can be held by the same or different MA holders. Therefore, the MA transfers are assessed on a national basis (individually per country), with specific national requirements which must be followed. For CAPs this is done on a whole-EU basis in one procedure. An extra caveat exists for MAs approved via a CAP with an orphan designation; the MAH must simultaneously transfer the orphan designation via a separate procedure to the MA transfer application.

JensonR+ has extensive experience with European procedures of all types, and local expertise across global markets through regulanet®, our partner network, that has representation in over 90 countries globally, and provides a diverse number of services and product expertise across the pharmaceutical and MedTech areas.

MA transfer applications can also induce further necessary processes, including those relating to the sunset clause, and often create changes to the Pharmacovigilance (PV) system. Both the regulatory and pharmacovigilance experts within JensonR+ can assist with these changes and process to ensure you maintain compliance.

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