Changes to a marketing authorisation

Application to change a marketing authorisation for a veterinary medicinal product in Luxembourg

In addition to your request on the Common European Submission Portal (CESP):

Documents required for a VRA (Variation Requiring Assessment)

1. The 'MAA change Type VRA' form, duly completed and signed.
2. A copy of the power of attorney, if you are acting on behalf of the marketing authorisation holder.
3. Approval of the Variation Requiring Assessment (VRA) in the Reference Member State (RMS).
4. The approval of the VRA from the country of origin for national procedures (NAP).
5. Proof of payment of the VRA.
6. If applicable, please attach the final appendices in PDF format and the revised Word version.

More than one variation may be grouped together in a single application.

Updating of the Union Product Database (UPD)

If a VNRA results in the product information being updated in the UPD database, please send us an email at luxvet@ms.etat.lu, specifying:

1. The commercial name of the product in Luxembourg
2. The veterinary medicinal product's UPD permanent identifier
3. The UPD product identifier
4. The most recent summary of product characteristics (SPC) in pdf format (< 10 MB), if the SPC is missing or needs updating
5. The authorisation holder's LOC ID and ORG ID
6. Any other useful additional information