Marketing authorisation application

Marketing authorisation application (MAA) for a veterinary medicinal product in Luxembourg

To obtain a marketing authorisation (MA) for a veterinary medicinal product in Luxembourg, you must submit an application file containing the following documents:

Required documents

  1. Application form: complete and sign the MAA form
  2. Power of attorney: provide a copy of the power of attorney if you are acting on behalf of the marketing authorisation holder (MAH).
  3. Summary of product characteristics (SPC): include the SPC in pdf format (less than 10 MB in size), as well as information on the product and its labelling – product information (PI), launch product (PL) – in French and/or in German. Multilingual packaging (FR/DE) is accepted.
  4. Proof of payment: attach proof of payment of the registration fees.
  5. If a Belgian or French marketing authorisation already exists, please include it in the application file.
  6. Final assessment report issued by Reference Member State (RMS).
  7. Union Product Database (UPD) identifiers: if the product exists in the UPD, please provide the veterinary medicinal product's permanent identifier, as well as its product identifier.

Submitting the application

All documents must be sent in a single email message to: luxvet@ms.etat.lu. Once the application has been received and approved, a marketing authorisation number will be allocated to you.

The three first digits of this number are specific to each holder, while the rest of the marketing authorisation number will remain unchanged throughout the life cycle of the medicinal product.

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