Marketing authorisation procedures

Marketing authorisation (MA) procedures for veterinary medicinal products in Luxembourg

Marketing authorisation applications for veterinary medicinal products must be filed using one of the following procedures:

1. The Centralised Procedure (CP), as defined in Articles 42 to 44 of Regulation 2019/6: with this procedure, a single MA is granted, which is valid throughout the European Union.
   
   Applications should be filed directly with the European Medicines Agency (EMA). The EMA's Committee for Medicinal Products for Veterinary Use (CVMP) is responsible for the scientific assessment of MA applications for medicinal products submitted using the CP. The CP is mandatory for certain medicinal products.
   
   
2. The Decentralised Procedure (DCP), as defined in Articles 48 and 49 of Regulation 2019/6: this procedure is to be used when the applicant wants to obtain an MA for a veterinary medicinal product in several Member States, and when, at the time of the application, an MA for the same product has not been granted in any Member State.
   
   
3. The Mutual Recognition Procedure (MRP), as defined in Articles 51 and 52 of Regulation 2019/6: this procedure is to be used when an MA has already been granted for a medicinal product in another Member State of the European Union.
   
   The Member State that has already granted an MA for the veterinary medicinal product then acts as the Reference Member State (RMS). If an MA has already been granted for the medicinal product in several Member States, one of those states will be chosen to act as the Reference Member State.
   
   
4. The Subsequent Recognition Procedure (SRP), as defined in Article 53 of Regulation 2019/6, is to be used when an MA has already been granted as part of the MRP and the MA holder wishes to have the authorisation extended to cover more Member States.
   
   This procedure is particularly suitable for Luxembourg.
   
   Currently, Luxembourg is only able to act in the capacity of a Concerned Member State (CMS) in a market authorisation procedure.
   
   
5. the National Procedure (NP), as defined in Article 46 of Regulation 2019/6: this procedure is to be used in cases where the applicant wishes to obtain a marketing authorisation for Luxembourg only. This procedure may not be used if a marketing authorisation has already been granted through a national procedure in a different Member State, or if an application is currently under review in a different Member State.
   
   This procedure is no longer used in Luxembourg for veterinary medicinal products placed on the market for the first time after 2022.