Exemption of veterinary medicinal products for certain pets – information about applications
The BVL provides time slots for the submission of applications for exemptions from the marketing authorisation requirement. Availability should be inquired in due time before the intended submission of the application.
Date: 21.08.2024
According to Art. 4 of the Veterinary Medicinal Products Act (TAMG), veterinary medicinal products for certain pets can be exempted from the marketing authorisation requirement under certain conditions. The exemption has to be granted by the BVL.
To ensure a smooth application process, the BVL provides time slots for the submission of applications. Applicants should inquire at least one month before the intended submission date per e-mail (tam-freistellung@bvl.bund.de) whether the desired time slot is available.
If the time slot is not available, the submission must be postponed. We would like to advise applicants who still market VMPs according to § 60 of the German Medicines Act to submit applications in due time before the end of the transition period according to Art. 152 (2) of Regulation (EU) 2019/6 to allow for a continued placing on the market after January 2027.
Applications may be submitted electronically using the application form provided by the BVL.
Further Information:
Procedural Guidance can be found here.
Year of issue
2024
Date
21.08.2024
Pressekontakt
Bundesamt für Verbraucherschutz und Lebensmittelsicherheit (BVL)
Presse und Öffentlichkeitsarbeit •
Gerichtstraße 49 •
13347 Berlin
Phone: 030 18444 -88250
• Fax: 030 18444 -89999
E-Mail: *
presse@bvl.bund.de