For applicants and companies
In this section, pharmaceutical companies and other applicants will find helpful information and forms for application procedures as well as answers to frequently asked questions.
Regulatory information regarding the COVID-19 pandemic can be found here.
Adverse event online reporting form for MAH offline as of 28.01.2022
The English website on Veterinary medicines is under construction. Please refer to the German website in case desired information cannot be found here.
Interesting facts
![Genehmigungen (Source: BVL) Das Bild zeigt Stempel auf einem Tisch. (Quelle: BVL)](/SharedDocs/Bilder/12_Teaserbilder/06_GT/teaser_Genehmigungen.jpg?__blob=normal&v=4)
General information
Quick access for pharmaceutical companies: Here you will find general information on marketing authorisations and their follow-up procedures in a nutshell.
![Elektronischer Vollzug der Tierarzneimittelzulassung (Source: wsf-f / Fotolia) Das Bild zeigt ein Netzwerkkabel und ein stethoskop auf einer Computer-Tastatur. (Quelle: wsf-f / Fotolia)](/SharedDocs/Bilder/12_Teaserbilder/05_TAM/teaser_eTAM.jpg?__blob=normal&v=6)
Advice on the electronic submission of procedural documents
The BVL strives to simplify the national and European marketing authorisation procedures for veterinary medicinal products as well as the post-marketing procedures.
![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?__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.
![Meldeformular für Tierarzneimittelengpässe (Source: adobe stock / Gina Sanders ) Das Bild zeigt eine leere Medikamentenverpackung (Quelle: adobe stock / Gina Sanders )](/SharedDocs/Bilder/12_Teaserbilder/00_Allgemein/teaser_Lieferengpass.jpg?__blob=normal&v=7)
Notification form for veterinary medicinal product shortages
A supply shortage is an interruption of a delivery of veterinary medicinal products that is expected to last longer than 2 weeks or a significantly increased demand that cannot be met adequately.
![Corona (Source: peterschreiber.media - stock.adobe.com) Das Bild zeigt eine Visualisierung des Corona-Virus.](/SharedDocs/Bilder/12_Teaserbilder/00_Allgemein/Corona-Virus-teaser.jpg?__blob=normal&v=4)
Regulatory flexibility in the context of the COVID-19 pandemic
More flexible interpretation of the legal framework for companies to respond to difficulties that may arise in the context of the pandemic.
![Brexit (Source: momius / Fotolia) Das Bild verweist auf Neuigkeiten zum Brexit.](/SharedDocs/Bilder/05_Tierarzneimittel/Brexit_NEWS.jpg?__blob=normal&v=7)
Brexit
The United Kingdom (UK) formally left the European Union (EU) on 31 January 2020 and became a third country. After ist withdrawal, UK no longer participates in the institutions and the decision-making of the EU – having regard to specific exemptions …
![Formulare (Source: Thomas Meinert / pixelio.de) Das Bild zeigt einen Aktenordner. (Quelle: Thomas Meinert / pixelio.de)](/SharedDocs/Bilder/12_Teaserbilder/05_TAM/teaser_Formulare.jpg?__blob=normal&v=8)
Forms
The forms required for submitting various procedural applications are available for download here.
![Kosten (Source: artefaktum / pixelio) Das Bild zeigt mehrere Euro-Münzen und Euro-Gelscheine. (Quelle: artefaktum / pixelio)](/SharedDocs/Bilder/12_Teaserbilder/05_TAM/teaser_Kosten.jpg?__blob=normal&v=8)
![Pharmakovigilanz-Informationen (Source: Markus Kauf / Fotolia) Das Bild zeigt ein Schaf auf einer Wiese. (Quelle: Markus Kauf / Fotolia)](/SharedDocs/Bilder/12_Teaserbilder/05_TAM/teaser_PharmakovigilanzInfo.jpg?__blob=normal&v=6)
Pharmacovigilance obligations and pharmacovigilance information for pharmaceutical companies
Pharmacovigilance obligations and information for marketing authorisation, exemption and registration holders as well as co-distributors.
![Weiterführende Informationen / Links (Source: carloscastilla - Fotolia) Das Bild zeigt einen Stapel von Zeitschriften.](/SharedDocs/Bilder/12_Teaserbilder/00_Allgemein/teaser_WeitereInfos.jpg?__blob=normal&v=8)
Further information on veterinary medicinal products
Here you will find links to other organisations providing further information.