Transfer of MA/change in name and address of the MAH

Transfer of the MAH from one company to another (other legal entity)

​The transfer of a Marketing Authorisation (MA) from one company to another legal entity is not classified in the Variation Regulation. The NOMA consider this as a Type IB A.z. Administrative, other variation for human medicinal products and as a VRA E.z. variation for veterinary medicinal products.

Please be aware that if the name of the medicinal product contains the name of the MA Holder, a notification of change in name must also be submitted. This is classified as a Type IB/VNRA, administrative variation no. A.2.

Change in MAH will also imply variation to the pharmacovigliance system. This is classified as a variation no. C.I.8 “ Introduction of a new pharmacovigliance system” in the Variation Regulation for human medicinal products and depending on the variations nature as a C.1, C.5 and/or C.6 in the EU Regulation 2019/6 for veterinary medicinal products.

If the product is approved via MRP or DCP, the transfer of MA to a new legal entity is regarded a purely national variation, while the change in name and variation to the pharmacovigliance system will have to be notified through the EU-procedure.

All information applicable for the product, like renewal date, is also valid after the transfer.

The following is to be submitted for the notification of change in MA Holder to another legal entity:

• Application form, type IB A.z. Adminstrative, other variation or VRA E.z.

• Confirmation from both parties on the agreement of transfer. It should also be confirmed that the transfer do not imply other changes to the product.

• Summary of product information, SmPC

• Package leaflet, PL

• Labelling text

• Mock-ups

Which order?

In which order should the transfer of the marketing authorization (MA), name change, and update of the pharmacovigilance system be submitted - and by who?

For nationally approved medicinal products

The transfer of the MA to a new legal entity must first be submitted by the existing MAH, with confirmation that the update of pharmacovigilance system information will be submitted by the new MAH immediately after approval. The application for a name change can be submitted by either the existing MAH or the new MAH.

For MRP/DCP

The transfer of the MA to a new legal entity must first be submitted nationally by the existing MAH, with confirmation that the update of pharmacovigilance system information will be submitted as a MRP change by the new MAH immediately after approval. The application for a name change can be submitted by either the existing MAH or the new MAH, but it is also classified as a MRP change.

Change of Nordic article number when changing the name of marketed medicinal products (see "Nordic article number").

Change in name and address of the MAH – same legal entity

This is classified as Variation A.1, Type IAIN , where the MA Holder may change the name and/or address, but where the legal entity is the same.

For conditions and documentation requirements, please see the Commission Guideline for human and veterinary medicinal products respectively.

In the case where several products are to be transferred, only one application form will need to be submitted, with an annexed list of applicable products.