DeutschEnglish

Transfer of ownership

Transfer of ownership - Transfer of title for a marketing authorisation/registration from the current marketing authorisation/registration holder to a new one New

 

AFTER authorisation/registration
(according to § 25 AMG or § 16 TAMG respectively)

Documents to be submitted

  • application form: change of ownership_DE-EN (F_Z31); see Downloads
  • waiver declaration of the current holder
  • take-over declaration of the future holder
  • updated texts (SmPC, PIL, LAB)
  • updated mock-ups for primary and secondary packaging

Submission, coming into effect and costs of the transfer

  • The necessary documents must be submitted via CESP.
  • Upon receipt of both complete declarations, the new holder shall immediately take over all rights and duties (provided they hold a wholesale permission according to § 9 AMG or § 8 TAMG respectively).
  • Costs are covered by the annual fee (see Schedule of Fees).

Change in product name, if necessary

Change in the name of a medicinal product due to a transfer of ownership according to § 25 AMG (Medicinal Products Act) or § 16 TAMG respectively must be submitted as a separate variation according to EC/1234/2008 (“Variation Regulation”) - classification E.1.b, type IB - in case of authorised human medicinal products, or according to Art 24 (2) Z1 (AMG) in case of registered human medicinal products.

For veterinary medicinal products, according to Commission Implementing Regulation (EU) 2021/17, a VNRA – classification A.2 – has to be submitted in the UPD after the new name has been reviewed and accepted by the BASG. 

This variation can be submitted at any time (before, at the same time as or after submission/closure of the transfer of ownership). 
These two procedures are usually completed at the same time, depending on temporal distance.

Change in pharmacovigilance system, if necessary

PRIOR to authorisation/registration
(not subject to § 25 AMG or § 16 TAMG respectively)

Necessary documents must be submitted via CESP within the scope of the authorisation/registration procedure.

Transfer of ownership prior to closure of a national marketing authorisation/registration procedure

Documents to be submitted

  • updated eAF strongly recommended
  • waiver declaration of the current holder
  • take-over declaration of the future holder
  • wholesale permission of the future holder (according to § 9 AMG or § 8 TAMG respectively)
  • updated texts (SmPC, PIL, LAB)
  • updated mock-ups for primary and secondary packaging
  • Information in the cover letter if the pharmacovigilance system remains unchanged, if e.g. current and future holder belong to the same parent company and use the same PSMF (Pharmacovigilance System Master File), or if it will be updated within the scope of the marketing authorisation/registration procedure.

Transfer of ownership prior to closure of an MRP/DCP
during the European phase of the procedure

Documents to be submitted

  • updated eAF
  • updated annex 5.3/wholsale permission of the future holder (according to § 9 AMG or § 8 TAMG)
  • updated annexes 5.19, 5.4, 5.10, if necessary
  • Information in the cover letter if the pharmacovigilance system remains unchanged, if e.g. current and future holder belong to the same parent company and use the same PSMF (Pharmacovigilance System Master File), or if it will be updated within the scope of the marketing authorisation/registration procedure.
  • In addition, for procedures with AT=CMS please send an e-mail to basg-cms@basg.gv.at informing us about the submitted transfer of ownership and state the following in the subject line: MRP-/DCP-number (CC/D/nnnn/sss) and „transfer prior authorisation“.

Transfer of ownership prior to closure of an MRP/DCP
during the national phase of the procedure

Documents to be submitted

  • updated annex 5.3/wholsale permission of the future holder (according to § 9 AMG or § 8 TAMG)
  • updated annexes 5.19, 5.4, 5.10, if necessary
  • waiver declaration of the current holder
  • take-over declaration of the future holder
  • updated texts (SmPC, PIL, LAB)
  • updated mock-ups for primary and secondary packaging
  • Information in the cover letter if the pharmacovigilance system remains unchanged, if e.g. current and future holder belong to the same parent company and use the same PSMF (Pharmacovigilance System Master File), or if it will be updated within the scope of the marketing authorisation/registration procedure.
  • In addition, for procedures with AT=CMS please send an e-mail to basg-cms@basg.gv.at informing us about the submitted transfer of ownership and state the following in the subject line: MRP-/DCP-number (CC/D/nnnn/sss) and „transfer prior authorisation“.

Downloads

Email

Further inquiry note

basg-cms@basg.gv.at