Transfer of marketing authorisation veterinary medicinal product
A transfer (change in legal person/entity) of the marketing authorisation to another marketing authorisation holder (MAH) falls outside the remit of Regulation number 1234/2008 (Variation Regulation).
When requesting a transfer of marketing authorisation holder, the following documents need to be submitted:
1. A cover letter and a change request form.
Please mention in the cover/submission letter that it concerns 'overdracht handelsvergunninghouder' (in Dutch) – transfer MAH (in English) – o.v.v. product type 313’.
When it concerns a transfer of multiple marketing authorisations (REG NLs) to the same marketing authorisation holder, this can all be mentioned in one single request. Please state all the relevant veterinary medicinal products (REG NLs) on the request form, under 'products concerned'.
2. A declaration from the current MAH agreeing to the transfer
These can be two separate declarations - one by the marketing authorisation holder that is transferring and one by the receiving marketing authorisation holder. But it may also be one single declaration, where the marketing authorisation(s) (REG NLs) and the marketing authorisation holders are mentioned and where both parties sign a single declaration.
The marketing authorisations and the associated responsibilities are transferred to the new marketing authorisation holder and the declaration may mention the new contact person for defects and recalls once the transfer is completed.
3. Declaration that there are no changes to the dossier of the marketing authorisation, with the exception of a new pharmacovigilance system (DDPS).
4. A copy of registration at the Chamber of Commerce of the new marketing authorisation holder
5. If applicable to the new marketing authorisation holder, permits (e.g. manufacturer/retail/wholesale)
6. Declaration of the new MAH that they will submit a request to change the pharmacovigilance system (if applicable) as soon as possible during or after the transfer of the MAH. Based on the Guidelines on the details of the various categories of variations, depending on the fact whether the pharmacovigilance system has been assessed previously or not, this is a C.II.7 change, type II or type IB.
7. Amended SPC, labelling and package leaflet (in Word format) which includes the name of the new marketing authorisation holder.
To submit a transfer of market authorisation, you are requested to submit all the above information to the Veterinary Medicines Agency. You can read how to do this on the page Submitting a dossier.