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 veterinary medicinal product itself and whether the pharmaceutical company/applicant 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 or the entire European Economic Area.

Veterinary medicinal products can be authorised by a:

• national procedure,
• mutual recognition procedure (MR procedure),
• decentralised procedure or
• centralised procedure.

Certain veterinary medicinal products can only be authorised by the European Commission (in a centralised procedure); these veterinary medicinal products are specified in Article 42 (2) of Regulation (EU ) 2019/6. For other veterinary medicinal products not listed in Article 42 (2), the centralised authorisation procedure may be optional, if no other marketing authorisation has yet been granted for the relevant product within the EU. Veterinary medicinal products not covered by Article 42 (2) of the Regulation can be authorised by the national authorities of the EU/EEA Member States (in the national procedure, the mutual recognition procedure or the decentralised procedure).

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) and
• the Federal Office of Consumer Protection and Food Safety (Bundesamt für Verbraucherschutz und Lebensmittelsicherheit, BVL).

The marketing authorisation of veterinary medicinal products is defined in Regulation (EU) 2019/6. The Regulation is implemented in accordance with the Veterinary Medicinal Products Act (Tierarzneimittelgesetz, TAMG). The Animal Health Act (Tiergesundheitsgesetz, TierGesG) and the Animal Vaccines Regulation (Tierimpfstoff-Verordnung, TierImpfStV) are also applicable provided they do not conflict with the provisions of the Regulation or are overridden by it.

The BVL is the competent authority for the marketing authorisation of the majority of veterinary medicinal products. According to § 65 TAMG, the Paul-Ehrlich-Institut is responsible for the marketing authorisation of the following veterinary medicinal products:

• immunological veterinary medicinal products within the scope of the TAMG
• monoclonal antibodies in the field of immunotherapy
• veterinary medicinal products for novel therapies in the field of immunotherapy
• animal allergens

According to Regulation (EU) 2019/6, immunological veterinary medicinal products are veterinary medicinal products intended to be administered to animals in order to produce active or passive immunity or to diagnose their state of immunity.

However, immunological veterinary medicinal products manufactured using pathogens or by biotechnology and that are intended to prevent, detect or cure animal diseases are exempted from the provisions of the TAMG. Pursuant to the TierGesG, the Paul-Ehrlich-Institut is responsible for the authorisation of the following immunological veterinary medicinal products:

• sera
• vaccines
• immunomodulators
• tuberculins

European authorisations are coordinated by the European Medicines Agency (EMA) or the Co-ordination Group for Mutual Recognition and Decentralised Procedures for Veterinary Medicinal Products (CMDv).

top