Documentation to be submitted

• form: change of ownership_DE-EN (F_Z31); see Downloads
• waiver declaration of the current marketing authorisation/registration holder
• take-over declaration of the future marketing authorisation/registration holder
• updated texts (SPC, PIL, LAB)
• MockUps for primary and secondary packaging

Who has to submit this documentation?

The future marketing authorisation/registration holder.

Upon receipt of both complete declarations, the new marketing authorisation/registration holder shall immediately take over all rights and duties concerning the product in question.

Costs?

All costs are covered by the annual fee (see Schedule of Fees).

Change in the name of the medicinal product, if necessary

Change in the name of a human medicinal product due to a change of ownership according to Art 25 Medicinal Products Act (Arzneimittelgesetz AMG) must be submitted as a separate variation according to EC/1234/2008 (“Variation Regulation”) - classification A.2.b, type IB - in case of authorised products or according to Art 24 (2) Z1 Medicinal Products Act (Arzneimittelgesetz AMG) for registered products.
For veterinary medicinal products a VNRA – classification A.2 – has to be submitted in the UPD after the new name has been reviewed and accepted by the BASG according to Commission Implementing Regulation (EU) 2021/17.

This variation can be submitted at any time (before, together with or after submission/closure of the change of ownership). Depending on their date of submission, these two procedures will usually be closed at the same time.

Change in the pharmacovigilance system, if necessary

• for authorisations of human medicinal products: see CMDh Questions & Answers - Variations - Question 2.8
• for authorisations of veterinary medicinal products: see CMDv Questions & Answers - Variations – Question 2.8
• for registrations: variation ("Änderung") according to Art 24 (5) Medicinal Products Act (Arzneimittelgesetz AMG)

Change of Ownership before closure of a national marketing authorisation/registration procedure

Change of Ownership before closure of a national marketing authorisation/registration procedure is not subject to Art 25 Medicinal Products Act (Arzneimittelgesetz AMG). The documents listed under "documentation to be submitted" must be submitted within the scope of the marketing authorisation/registration procedure.

Change of Ownership before closure of an MRP/DCP

during the European procedure:

• The future marketing authorisation holder may be changed only once.
• prerequisite: The future marketing authorisation holder's pharmacovigilance system has already been noted.

between closure of the European procedure and authorisation on the national level:

• prerequisite: The future marketing authorisation holder's pharmacovigilance system has already been noted.