Responsibilities
Germany
In Germany, the Federal Office of Consumer Protection and Food Safety (BVL) is the competent authority for the authorisation of veterinary medicinal products. The Federal Ministry of Health (BMG) is responsible for the technical supervision of this area; otherwise, the BVL is an independent higher federal authority within the remit of the Federal Ministry of Food and Agriculture (BMEL) and thus occupies an intermediate position. The Paul Ehrlich Institute (PEI) is responsible for the authorisation of sera and vaccines for animals. The BVL co-operates with the Federal Environment Agency (UBA) with regard to the assessment of the potential environmental impact of veterinary medicinal products. The authorisations and registrations of veterinary medicinal products granted by the BVL form the basis for monitoring the circulation of medicinal products, which is generally the responsibility of the federal states.
The task of the veterinary authorities of the federal states is, for example, to prevent and combat animal diseases, to protect people from health hazards caused by pathogens of animal origin, to preserve the life and well-being of animals and to prevent animal suffering. Through their monitoring tasks, they also protect against damage, misleading and deception through food and products of animal origin. In addition, they have the task of protecting the environment from harmful influences that may emanate from animals, animal products and waste.
European Union
The BVL also fulfils important and extensive tasks for the European Medicines Agency (EMA). The EMA, based in Amsterdam, coordinates the evaluation and monitoring of medicinal products in the European Union and brings together the scientific resources of the 27 EU Member States in a network of 42 national authorities. If a centralised European marketing authorisation is sought, the application is processed by the relevant scientific committees of the EMA, in which staff from the competent authorities of each EU Member State, including the BVL, are represented.
The BVL participates with its experts in EMA's Scientific Committee for Veterinary Medicinal Products (CVMP) and its working groups.
The BVL is represented in various working groups at the level of the EU Commission and the Council of the EU, in particular in the "SANTE" Directorate-General.
International activities
The Programme for International Cooperation on Harmonisation of Technical Requirements for the Registration of Veterinary Medicinal Products (VICH) was set up to harmonise the requirements for the registration of veterinary medicinal products between the EU, Japan and the USA. Guidelines for pharmacological-toxicological, pharmaceutical and clinical areas have already been adopted and implemented in the participating countries and the EU. The BVL is closely involved in these activities. The BVL is also involved in the Codex Alimentarius Committee of the World Health Organisation (WHO) on residues from veterinary medicinal products in food.