BVL - Announcements

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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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

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

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

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

Permit of plant protection products for the application by drones in steep slope vineyards

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

Equivalence Assessments will remain limited

Subsequent allocation of zRMS for applications according to Article 43

Procedure for applications still to be submitted under Article 43 for which no zRMS has yet been allocated.

Updated version is available for all four electronic application forms (eAF)

Successful HMA Veterinary Stakeholder Meeting

Federal Office of Consumer Protection and Food Safety (BVL) hosts the HMA Veterinary Stakeholder Meeting to discuss the Implementation of Veterinary Medicines Regulation (Regulation (EU) 2019/6)

EU2020 – Germany's Presidency of the Council of the European Union

Federal Office of Consumer Protection and Food Safety hosted Meeting of the European Heads of Medicines Agencies

Inclusion of nicotine-free e-cigarettes and refillable containers in the scope of application of the German tobacco products act from January 1, 2021

Equivalence Assessments will remain limited until mid-2021

Successful CVMP-CMDv-Presidency Meeting (German Presidency of the Council of the European Union)

CVMP-CMDv-Presidency Meeting as part of the German Presidency of the Council of the European Union

Novel detection method makes promises towards the specific detection of genome edited canola lines – what is really achievable by the new method?

Limitation on equivalence assessments until end of 2020

Opinion of the BVL on the assessment of hemp extracts is unchanged

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