Marketing Authorisation (Veterinary)
Veterinary medicinal products intended to be marketed in Germany generally require official approval in the form of a national marketing authorisation or a marketing authorisation by the European Commission.
There are several procedures available for the marketing authorisation of veterinary medicinal products. The type of marketing authorisation procedure depends on the medicine itself and whether the pharmaceutical company intends to market the veterinary medicinal product
- only in Germany,
- in several member states of the European Union (EU) or the European Economic Area (EEA) or
- throughout the European Union (EU) or the entire European Economic Area (EEA).
Veterinary medicinal products can be authorised by a:
- national procedure
- mutual recognition procedure (MR procedure)
- decentralised procedure
- centralised procedure.
Certain veterinary medicines can only be authorised by the European Commission (in a centralised procedure); these medicinal products are listed in the Annex to European Regulation (EC) No 726/2004. For some veterinary medicines, the centralised authorisation procedure may be optional; these medicinal products are subject to Article 3 (2) of Regulation (EC) No 726/2004. All veterinary medicinal products not covered by this Regulation can only be authorised by the national authorities of the EU / EEA Member States (in the national procedure, the mutual recognition procedure or the decentralised procedure).
Comprehensive information on (animal) pharmaceutical legislation at European level can be found on the website of the Directorate-General for Enterprise and Industry of the European Commission ("EudraLex").
Responsibilities in Germany and the EU
The competent national authorities for the authorisation of veterinary medicinal products in Germany are
- the Paul-Ehrlich-Institut (PEI)
- the Friedrich-Loeffler-Institut (FLI)
- the Federal Office of Consumer Protection and Food Safety (BVL).
The BVL is the competent authority for the marketing authorisaiton of the majority of veterinary medicinal products; the regulations for this are laid down in the German Medicines Act (Arzneimittelgesetz - AMG).
However, veterinary medicinal products manufactured using pathogens or by biotechnology which are intended to prevent, detect or cure animal diseases are exempted from this regulation (Section 4a sentence 1 no. 1 AMG). These are immunological veterinary medicines and in-vitro diagnostic medical devices, the authorisation of which has been regulated by the Animal Health Act (TierGesG) (previously Animal Infection Act [Tierseuchengesetz]) since 1 May 2014 and in the Veterinary Vaccines Regulation (Tierimpfstoff-Verordnung).
The Veterinary Vaccines Regulation also regulates the competence of PEI and FLI as licensing authorities.
Pursuant to Section 2 (2) (1) of the Veterinary Vaccines Regulation, the Paul-Ehrlich-Institut (PEI) is responsible for the authorisation of the following immunological veterinary medicinal products:
- other veterinary medicines.
According to Section 2 (2) no. 2 of the Veterinary Vaccines Regulation, the FLI is responsible for the authorisastion of in vitro diagnostic medical devices for the detection of notifiable animal diseases or animal diseases requiring notification.
European authorisations are coordinated by the European Medicines Agency (EMA).