Announcements

Here you will find announcements from the tasks of the BVL. Announcements are aimed - to put it simply - at experts, applicants, producers and of course also at the interested public. Please note: The greater part of the announcements published by the BVL is only available in German. Search through the German-language technical reports here.

All announcements

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SPC harmonisation 2023 - end of procedure for products Catosal and Domosedan

Harmonised product information texts (EN version) for reference veterinary medicinal products Catosal and Domosedan available on CMDV homepage.
Action for marketing authorisation holders of the respective generic or hybrid veterinary medicinal products for alignment of the SPC: Application for the respective variation requiring assessment.

Guidance on the submission of G.I.18 Variations Requiring Assessment published on CMDv website

Facilitating efficient processing of variations requiring assessment (VRAs) for one-off alignment of the product information with version 9 of the QRD templates

Kexxtone 32.4 g continuous-release intraruminal device for cattle (monensin): marketing authorisation suspension and market recall of all batches

On 23 April 2024, the Committee for Veterinary Medicinal Products (CVMP) of the European Medicines Agency (EMA) decided by consensus to recommend suspending the marketing authorization of “Kexxtone - Monensin sodium” and to recall batches that have been released in the Union. The European Commission has now followed this opinion and issued a corresponding implementing decision on 15 May 2024. Animal Healthcare Professionals should no longer use Kexxtone and consider other appropriate alternatives.

BVL Applicant Portal - Provision of fee notices as of 15th February 2024

Mutual recognition - Formal requirements

Notifications of applications for authorisation of plant protection products

New functional email address

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.

New format of unique case numbers

First steps for the transition to the AE reporting format VICH

Working documents on the nature and level of residues in fish published

Updated website on Residues

New regulation on fees in the field of veterinary medicinal products

Changes in fee legislation - BMGBGebV and BMELBGebV

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