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

Search results 1 to 10 from a total of 38

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Kategorie der Nachricht: Announcement Date: 03.09.2024

Pharmacovigilance responsibilities for „pet veterinary medicinal products”

Important information regarding pharmacovigilance for exemption holders according to §4 TAMG

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Kategorie der Nachricht: Announcement Date: 21.08.2024

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.

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.

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Kategorie der Nachricht: Announcement Date: 08.08.2024

Senvelgo® (velagliflozin) 15 mg/ml oral solution for cats

Known risk of diabetic ketoacidosis (DKA) in cats with diabetes mellitus associated with the use of the product

Senvelgo® 15 mg/ml oral solution for cats was first authorised in the European Union (EU) in November 2023. In a communication coordinated with the European Medicines Agency (EMA) and the competent authorities of the Member States, the marketing …

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Kategorie der Nachricht: Announcement Date: 14.06.2024

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.

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Kategorie der Nachricht: Announcement Date: 13.06.2024

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

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Kategorie der Nachricht: Announcement Date: 04.06.2024

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.

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Kategorie der Nachricht: Announcement Date: 15.02.2024

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

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Kategorie der Nachricht: Announcement Date: 04.12.2023

Mutual recognition - Formal requirements

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Kategorie der Nachricht: Announcement Date: 25.01.2023

Notifications of applications for authorisation of plant protection products

New functional email address

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Kategorie der Nachricht: Announcement Date: 22.11.2022

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.

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