No more forwarding of AERs to marketing authorization holders
With immediate effect, the forwarding of AERs received by the BVL to the affected marketing authorization holders will be discontinued.
Date: 22.11.2022
Until now, the BVL temporarily offered to continue transmitting the cases to involved marketing authorization holders in the established way. This was done without assurance of completeness and did not relieve the marketing authorization holder of his legal obligations under Article 77 of Regulation (EU) 2019/6. In the course of the circulation of the new version of the EVVet - Best practice guide (v.10), EMA has now informed marketing authorisation holders that the temporary practice of forwarding AERs by national competent authorities to the relevant marketing authorization holders has been terminated. Instead, marketing authorization holders are now responsible for downloading any AERs related to their products from EVVet.
For this reason, BVL is discontinuing the forwarding of AERs to marketing authorization holders as of now.
Year of issue
2022
Date
22.11.2022
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