Tasks in the field of veterinary medicinal products
The BVL is the national competent authority for the authorisation of veterinary medicinal products and related post-marketing procedures. The marketing authorisation is intended to ensure the quality, efficacy and safety of veterinary medicinal products.
An overview
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Who does what?
Numerous authorities and institutions in Germany and the EU contribute to having veterinary medicinal products available for as many treatable diseases as possible.
![Genehmigung für Prüfungen nach §10 TAMG (Source: Ralf Geithe - stock.adobe.com) Das Bild zeigt einen Haken an erledigte Aufgaben auf einer Liste.](/SharedDocs/Bilder/12_Teaserbilder/00_Allgemein/teaser_TAMG-Pruefung.jpg;jsessionid=78DCAF17BB2FBF7115BFE4A3AAB58F20.internet002?__blob=normal&v=4)
Approval of clinical trials according to §10 TAMG
The application form including required annexes as well as information on how to apply for the approval of clinical trials according to §10 of the Veterinary Medicinal Products Act (TAMG) can be found here.
![Zulassung von Tierarzneimitteln (Source: Marcus Gloger / BVL) Das Bild zeigt eine Hand, die eine Spritze hält. (Quelle: Marcus Gloger / BVL)](/SharedDocs/Bilder/12_Teaserbilder/05_TAM/teaser_ZulassungTAM.jpg;jsessionid=78DCAF17BB2FBF7115BFE4A3AAB58F20.internet002?__blob=normal&v=5)
Marketing authorisation, registration and exemption from marketing authorisation
Veterinary medicinal products that are intended to be placed on the market must go through a corresponding application procedure. Special regulations exist for homeopathic products and veterinary medicinal products for certain pet animals.
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Residues of veterinary medicinal products in foodstuffs
Active substances intended to be used for the treatment of food-producing animals are subject to strict legal regulations in the EU.
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Monitoring and risk management
Veterinary medicinal products continue to be monitored and evaluated once they have been authorised. Even if therapy is performed with greatest care, the occurrence of adverse drug reactions cannot always be avoided.
![Mikrotiterplatten (Source: BVL (Tchegloff)) Antibiogramm erstellt mit der Methode der Bouillon-Mikrodilution](/SharedDocs/Bilder/05_Tierarzneimittel/AntibiotikaResistenzen/Mikrotiterplatten.jpg;jsessionid=78DCAF17BB2FBF7115BFE4A3AAB58F20.internet002?__blob=normal&v=7)
Tasks in the area of antibiotic resistance
The BVL fulfils various tasks to limit antibiotic resistance in the field of animal health under the umbrella of the German Antibiotic Resistance Strategy (DART 2020).
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Historical legislation until 28 January 2022 & transitional arrangements
Since 28 January 2022 a new legislation with regard to veterinary medicinal products has been applied. Here you will find details of former legislation that was applied until 28 January 2022 as well as important transitional arrangements.
![Krisenmanagement Tierarzneimittel (Source: galitskaya / stock.adobe.com) Das Bild zeigt Hände einer Familie und eine pelzige Pfote einer Katze.](/SharedDocs/Bilder/12_Teaserbilder/05_TAM/teaser_KrisenmanagementTAM.jpg;jsessionid=78DCAF17BB2FBF7115BFE4A3AAB58F20.internet002?__blob=normal&v=2)
Crisis management for veterinary medicinal products at the BVL
The crisis management for veterinary medicinal products acts as an interface between European partner authorities as well as national and international stakeholders.
Direct access
Adverse event reporting – for veterinarians
Adverse event reporting – for animal owners
Higher federal authorities and responsible federal ministries
Find out more
- Tasks in the area of veterinary drugs
- For applicants and companies