Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 April 2022
Under Regulation (EU) 2019/6, the Committee adopted by consensus, a positive opinion for a variation requiring assessment application (subject to worksharing procedure) concerning quality-related changes for Purevax RC, Purevax RCP FeLV, Purevax RCPCh FeLV, Purevax RCPCh, Purevax RCP.
Under Regulation (EC) No 1234/2008, the Committee adopted by consensus, a positive opinion for a
grouped type II variation application concerning the reduction of the minimum protective dose for Gumbohatch together with other quality-related changes.
- Bonqat (grouped)
- NexGard Spectra
- Rabitec (grouped)
The Committee adopted five scientific advice reports further to requests for initial advice. Two requests concerned biological products and three requests concerned pharmaceutical products. The respective target species were dogs, horses (two products), pigs, and chickens.
Under Regulation (EC) No 726/2004
The Committee reviewed the PSURs for Gumbohatch, HorStem, SevoFlo, and Virbagen Omega, and concluded that no further action was required.
The Committee reviewed the marketing authorisation holder’s appeal of the January 2022 CVMP PSUR outcome for Stelfonta and confirmed its previous recommendation for changes to the summary of product characteristics.
The Committee adopted a recommendation for changes to the summary of product characteristics for BTVPUR as an outcome of signal detection activities.
Regulation (EU) 2019/6
The Committee adopted the following guidance documents related to Regulation (EU) 2019/6:
- Procedural advice for veterinary vaccine antigen master file (VAMF) certification (EMA/CVMP/127488/2021). The comments received during the consultation procedure have been considered for the drafting of the procedural advice.
- Revised procedural advice on accelerated assessment of marketing authorisation applications pursuant to Article 44 (3) of Regulation (EU) No 2019/6 (EMA/CVMP/32995/2006 – Rev. 1).
Cooperation with other EU agencies
The Committee adopted a draft report on the development of a harmonised approach on exposure assessment methodologies for residues from VMPs, feed additives and pesticides in food of animal origin. A 2-month period of public consultation on this report will be launched after its endorsement by the EFSA Scientific Committee and subsequent review by the European Commission.
The Committee adopted a revised procedure for nomination and appointment of co-opted members (EMA/747064/2021).
More information about the above-mentioned medicines, including their full indications, guidelines, reflection papers, questions and answers and other documents, such as overviews on comments received during consultation, can be found below in “Related content”.