Transfer of marketing authorisation veterinary medicinal product
A transfer of a marketing authorisation to another marketing authorisation holder (MAH) is not covered by the Veterinary Medicinal Products Regulation.
Do you want to submit a marketing authorisation holder transfer? You submit this application as a national application to the Veterinary Medicinal Products Unit. You can read how to do this under the submission file . You provide all the information below with your request. After approval of the marketing authorisation holder transfer, the information must also be updated in the Union Product Database (UPD). You can do this in the UPD via the Other Post-Authorisation Data (OPAD) section. As long as this is not yet possible in the UPD, you can ask the Veterinary Medicinal Products Unit to change the marketing authorisation holder of the product via an update.
When submitting a 'marketing authorisation holder transfer', you provide the following documents:
- An accompanying letter and a change request form. Indicate in the accompanying letter that it concerns a transfer of a marketing authorisation holder (MAH). If it concerns a transfer of several marketing authorisations (REG NL's) to the same marketing authorisation holder, this can all be mentioned in one application. In this case, state on the application form, under 'products concerned', all relevant veterinary medicinal products (REG NL's). You can use the variation classification 'E.z' in the application form.
- Declaration that marketing authorisations are being transferred. These can be two separate declarations – one from the transferring marketing authorisation holder and one from the receiving marketing authorisation holder. But it can also be one statement, on which both the marketing authorisation(s) (REG NL's) and the marketing authorisation holders are stated and where both parties sign on one declaration. The marketing authorisations and the associated responsibilities are transferred to the new marketing authorisation holder and the declaration may also mention the person who, after transfer, is the contact person for product defects and recall of veterinary medicinal products.
- Statement that with the exception of a new pharmacovigilance system (attach the summary of PSMF) there are no changes to the marketing authorisation dossier.
- An extract from the Chamber of Commerce of the new marketing authorisation holder.
- Authorisations where applicable (e.g. manufacturer/retail/wholesale) to new marketing authorisation holder.
- Modified SPC, labeling and package leaflet (in a Word document) including the name of the new marketing authorisation holder.
Do you have any questions about transferring a marketing authorisation? Ask your question to the Veterinary Medicinal Products Unit via our contact form.