Meeting highlights from the Committee for Medicinal Products for Veterinary Use (CVMP) 10-12 May 2021
CVMP opinions on veterinary medicinal products
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Bonqat (pregabalin) from Orion Corporation, a new product for the alleviation of acute anxiety in cats.
The Committee adopted by consensus a positive opinion for a type II variation application for Simparica Trio concerning quality-related changes. The Committee also adopted by consensus a type IB variation grouped application (subject to a worksharing procedure) for Vectra 3D and Vectra Felis concerning quality-related changes.
Community referrals and related procedures
The Committee concluded the referral procedure for injectable veterinary medicinal products containing vitamin A for use in food producing species. The matter was referred to the Committee by Germany under Article 35 of Directive 2001/82/EC due to concerns relating to the appropriateness of the withdrawal periods in food producing species and user safety. The Committee agreed that the withdrawal periods for milk, meat and offal derived from treated food producing species should be amended. The Committee adopted by consensus an opinion recommending regulatory and risk mitigation measures to provide assurance for consumer and user safety.
The Committee endorsed one clarification report relating to scientific advice previously provided for a pharmaceutical product for dogs and cats.
Minor use, minor species (MUMS)/limited market
Following the Committee’s review of one request for classification under the MUMS/limited market policy, the CVMP classified a product (ATCvet classification: immunologicals) for cattle as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is eligible for financial incentives as it is intended for use in food producing species.
The Committee reviewed the PSURs for Cytopoint and Draxxin and a signal detection outcome for Osurnia and concluded that changes to their product information were required.
The Committee also reviewed the PSURs for Circovac, Clynav, Mirataz, Panacur AquaSol, Posatex and Spironolactone Ceva and concluded that no further action was required.
Concept papers, guidelines and SOPs
The Committee adopted an updated reflection paper on methods found suitable within the EU for demonstrating freedom from extraneous agents of the seeds used for the production of immunological veterinary medicinal products (EMA/CVMP/IWP/251741/2015) for a two-month period of public consultation.
Regulation (EU) 2019/6
The Committee adopted a joint EMA/CMDv guidance on the details of the classification of variations requiring assessment according to Article 62 of Regulation (EU) 2019/6 for veterinary medicinal products and on the documentation to be submitted pursuant to those variations (EMA/CMDv/190673/2021).
The document will be sent to the Heads of Medicines Agencies for endorsement and published on the Agency’s website in due course.
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”.