According to the Veterinary Medicinal Products Regulation (EU) 2019/6 there are two types of variations:
- variations not requiring assessment, which have minimal or no impact on the quality, safety or efficacy of the medicine, as listed in Commission Implementing Regulation (EU) 2021/17;
- variations requiring assessment.
Further information regarding variations can be found from CMDv Guidance documents.
The use of the eAF (electronic application form) is mandatory for all applications (MRP, DCP and national procedure applications for marketing authorisation variations). Further details can be found on: eSubmission: VET eSub (europa.eu) and CMDv website.
How to submit a variation for Transfer of Marketing Authorisation?
Type of procedure
A Transfer of Marketing Authorisation (MA) from the existing Marketing Authorisation Holder (MAH) to a new MAH has to be submitted nationally (also for MRP or DCP) as variation requiring assessment (VRA) under category E.z – Transfer of marketing authorisation to different legal entity, following standard timetable of 60 days.
Document to be provided:
- Declaration stating the date on which the Transferor and the Transferee finalise the transitional organisational arrangements and the Transferee takes over all responsibilities (must be signed by both the Transferor and the Transferee).
- Contact details of the person responsible for communication between the MAH and State Agency of Medicines and letter of authorisation.
- Information on whether the phamacovigilance system master file (PSMF) and Qualified Person for pharmacovigilance (QPPV) remain the same or are changed.
- Revised product information and the implementation date of the variation.
- Proof of establishment of the MAH in the EEA.
Follow up requirements:
Evidence must be provided that a Pharmacovigilance System Master File (PSMF) is in place for the new MAH and a variation to replace or change an existing summary of the PSMF, or introduce a new summary of the PSMF has been/will be submitted according to the current legislation. See also CMDv Q&A - List for the submission of variations according to Regulation (EU) 2019/6.
Last updated: 13.04.2023