Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 15-16 February 2022
The Committee adopted the scientific advice on the designation of antimicrobials or groups of antimicrobials reserved for treatment of certain infections in humans. This advice relates to the implementing act referred to in Article 37(5) of Regulation (EU) 2019/6 (EMA/CVMP/678496/2021).
CVMP opinions on veterinary medicinal products
Under Regulation (EC) No 726/2004
The Committee adopted by consensus a positive opinion for a marketing authorisation application for Chanaxin (tulathromycin), from Chanelle Pharmaceuticals Manufacturing Limited, a new generic product for the treatment and metaphylaxis of bovine respiratory disease, treatment of infectious bovine keratoconjunctivitis, treatment and metaphylaxis of swine respiratory disease, and treatment of the early stages of infectious pododermatitis in cattle, pigs, and sheep, respectively.
The Committee adopted by majority a positive opinion for a marketing authorisation application for RenuTend (tenogenic primed equine allogeneic peripheral blood-derived mesenchymal stem cells), from Boehringer Ingelheim Vetmedica GmbH, a new product to improve healing of injuries of tendons and suspensory ligaments in horses.
Under Regulation (EC) No 1234/2008
The Committee adopted by consensus, positive opinions for type II variation applications concerning quality-related changes for:
- Forceris (grouped)
- Veraflox (grouped)
The Committee adopted by consensus a positive opinion for a type IB variation application (subject to a worksharing procedure) for:
- Purevax RCPCh FeLV, Purevax RCP FeLV, Purevax RCP, Purevax RC and Purevax RCPCh (Feline calicivirosis vaccine - inactivated, feline viral) concerning the implementation of changes in section 4.6 of the SPC that were approved in the 10th PSURs assessment (PSUR covering period 01 March 2018 - 28 February 2021)
- Metacam and Novem (Meloxicam) concerning quality-related changes
Union referrals and related procedures
The Committee started a procedure for veterinary medicinal products containing procaine benzylpenicillin as a single active substance presented as suspensions for injection. The matter was referred to the Committee by Germany under Article 82 of Regulation (EU) 2019/6 due to concerns that the authorised duration of treatment for some of the concerned products might not be sufficiently long to ensure effective use of these medicines, which could also contribute to the development of antimicrobial resistance. The CVMP invites all stakeholders (e.g. veterinary healthcare professionals, farmers, academia) to submit data relevant to this procedure.
Maximum residue limits
The Committee agreed to include benzoic acid, zinc salt (CAS number 553-72-0), neodecanoic acid, calcium salt (CAS number 27253-33-4), and tripropylene glycol (CAS number 24800-44-0) as new entries in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009, with regard to residues of veterinary medicinal products in foodstuffs of animal origin, under the heading of excipients. This decision followed the Committee’s review of requests submitted in accordance with the relevant CVMP guidance.
The Committee adopted the updated list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 – Rev. 51.
The Committee adopted four scientific advice reports and endorsed one clarification of a scientific advice concerning pharmaceutical, biological and immunological products, further to requests for three initial advices, one follow-up advice and a clarification. The target species were dogs (three products), ducks (one product) and cats (one product).
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following four requests, the CVMP classified:
- A product (ATCvet classification: Immunologicals) for horses, and a product for chickens (ATCvet classification: Immunologicals), as intended for a limited market but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
- A product (ATCvet classification: Immunologicals) for turkeys, as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
The decision on the request for a product (ATCvet classification: Immunologicals) for Atlantic salmon has been deferred to March CVMP.
The Committee reviewed an appeal request for classification of a veterinary medicinal product (ATCvet classification: Alimentary tract and metabolism for dogs) as intended for a limited market according to Article 4(29), and for eligibility for authorisation under Article 23 of Regulation 2019/6. The Committee confirmed its previous considerations and classified the product as intended for a limited market but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Under Regulation (EC) No 726/2004
The Committee reviewed the PSURs for Arti-Cell Forte, Comfortis, Daxocox, ProteqFlu, ProteqFlu-Te, and Simparica Trio and concluded that no further action was required.
The Committee adopted recommendations for changes to the summary of product characteristics for Neptra and Nobivac Myxo-RHD Plus as outcome of signal detection activities.
Concept papers, guidelines and SOPs
The Committee adopted a reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6 (EMA/CVMP/ERA/622045/2020), following the close of the public consultation. The comments received during the consultation procedure have been considered for the revision of the reflection paper. This reflection paper has been developed to provide guidance on when an environmental risk assessment can be requested by competent authorities in the frame of marketing authorisation applications for generic veterinary medicinal products.
Regulation (EU) 2019/6
The Committee adopted the following, in relation to Regulation (EU) 2019/6:
- A draft reflection paper on the criteria for determining that an active substance is essential when considered in the context of Article 37(2)(j) of Regulation (EU) 2019/6 (EMA/CVMP/83202/2022) for a 3-month period of public consultation.
- Procedural advice on the exceptional extension of assessment time for initial marketing authorisation applications by 90 days under Article 44(2) of Regulation (EU) 2019/6 (EMA/CVMP/612534/2021).
The Committee re-elected Dr Christine Schwarz as chair of the Antimicrobials Working Party (AWP) for a 3-year mandate.
The Committee re-elected Dr Ricardo Carapeto García as chair of the Environmental Risk Assessment Working Party (ERAWP) for a 3-year mandate.
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'.
- Arti-Cell Forte: EPAR
- Comfortis: EPAR
- Daxocox: EPAR
- Forceris: EPAR
- Neptra: EPAR
- Nobivac Myxo-RHD Plus: EPAR
- ProteqFlu: EPAR
- ProteqFlu-Te: EPAR
- Purevax RC: EPAR
- Purevax RCP: EPAR
- Purevax RCP FeLV: EPAR
- Purevax RCPCh: EPAR
- Purevax RCPCh FeLV: EPAR
- Simparica Trio: EPAR
- Strangvac: EPAR
- Tulissin: EPAR
- Veraflox: EPAR