Pharmacovigilance responsibilities for „pet veterinary medicinal products”

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

Read more

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.

Read more

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 …

Read more

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.

Read more

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

Read more

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.

Read more

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.

Read more

New format of unique case numbers

First steps for the transition to the AE reporting format VICH

Read more

New regulation on fees in the field of veterinary medicinal products

Changes in fee legislation - BMGBGebV and BMELBGebV

Read more

Transitional arrangements on marketing authorisations for veterinary medicinal products whose five-year period of validity expires on or after the date of application of Regulation (EU) 2019/6

On 09.07.2021, the European Commission published in the Official Journal of the EU transitional rules on marketing authorisations for veterinary medicinal products whose five-year validity period expires on or after 28 January 2022. This notice …

Read more