This Austrian Ministerial Ordinance establishes the national framework for pharmacovigilance of veterinary medicinal products, implementing requirements under the Tierarzneimittelgesetz (TAMG) and aligning with Regulation (EU) 2019/6. It applies to all authorised and registered veterinary medicinal products in Austria, including homeopathic veterinary preparations, and defines reporting obligations for adverse events. Veterinarians and other authorised persons must report suspected adverse reactions to the Federal Office for Safety in Health Care within 30 days, while marketing authorisation holders must comply with EU-level pharmacovigilance duties, including signal management and appointment of a responsible pharmacovigilance person. The Ordinance also regulates reporting procedures and formats, primarily requiring electronic submission through official systems or forms, with fallback options if digital reporting is unavailable.
Austria · 2025-02-03