Pharmacovigilance obligations and pharmacovigilance information for pharmaceutical companies
Pharmacovigilance obligations and information for marketing authorisation, exemption and registration holders as well as co-distributors.
The English website on Veterinary medicines is under construction. Please refer to the German website in case desired information cannot be found here.
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PSMF and pharmacovigilance inspections
The PSMF (Pharmacovigilance System Master File) describes the pharmacovigilance system of a marketing authorisation, exemption or registration holder. To check compliance with legal requirements, the BVL carries out pharmacovigilance inspections.
Electronic submission of adverse event reports
Reports of adverse events following the use of veterinary medicinal products are to be reported electronically to EMA. Different options are available for this purpose.
Information for representatives of the marketing authorisation holder and co-distributors
Representatives of the marketing authorisation holder and co-distributors may also have certain obligations with regard to the recording and forwarding of adverse event reports following the use of the veterinary medicinal products they distribute.
Annual publications on AE reports (German only)
Find out more
- General information
- Advice on the electronic submission of procedural documents
- Approval of clinical trials according to §10 TAMG
- Notification form for veterinary medicinal product shortages
- Regulatory flexibility in the context of the COVID-19 pandemic
- Brexit
- Forms for various procedures in the veterinary field
- Costs
- Pharmacovigilance obligations and pharmacovigilance information for pharmaceutical companies
- Further information on veterinary medicinal products
- Register of online veterinary medicinal products retailers