​​​The transfer of a Marketing Authorisation (MA) from one company to another legal entity is not classified in the Variation Regulation. The Norwegian medicines Agency consider this as a A. Administrative  variation,  z) other variation, Type IB.

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 an administrative variation nr A.2 in the Variation Regulation.

Change in MA Holder will also imply variation to the pharmacovigliance system. This is in the new Variation Regulation classified as a variation no. C.I.8  “ Introduction of a new pharmacovigliance system”.

If the product is approved via the Mutual Recognition- or Decentralised Procedure, 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 ticked: A. Administrative variation, z)other variation Type IB
  • 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
  • Patient Information Leaflet, PIL
  • Labelling (mock-ups)

Response from the Norwegian Medicines Agency:

The new MA Holder will receive a confirmation of the transfer, together with approved SmPC, PIL and labeling. The previous MA Holder receives a copy of the confirmation.

Publisert: 19.08.2016