Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 10-12 May 2022
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The Committee elected Mr Gerrit Johan Schefferlie from the Netherlands as its new Chair for a 3-year mandate.
CVMP opinions on veterinary medicinal products
Under Regulation (EU) 2019/6
The Committee adopted by consensus a positive opinion for a variation requiring assessment application for Vectormune ND (Newcastle disease and Marek’s disease vaccine (live recombinant))concerning the addition of the compatibility claim on the simultaneous use of Vectormune ND with another vaccine.
The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:
- Sileo
- Apoquel
- Innovax ND IBD
- Zenalpha
Under Regulation (EC) No 1234/2008
The Committee adopted by consensus a positive opinion for a grouped type II variation application for Suprelorin (Deslorelin)concerning the addition of a new therapeutic indication (in female dogs) and the addition of a non-food producing target species (cats, for use in males).
The Committee adopted by consensus positive opinions for type II variation applications concerning quality-related changes for:
- Innovax ND ILT (grouped)
- Canigen L4, Nobivac L4 (grouped, worksharing procedure)
- Credelio Plus
- Fortekor Plus (grouped)
Union referrals and related procedures
The Committee started a procedure for veterinary medicinal products containing N-methyl-pyrrolidone as an excipient. The matter was referred to the Committee by Germany under Article 82 of Regulation (EU) 2019/6 due to concerns relating to the appropriateness of user and target animal safety warnings in view of the teratogenic potential of N-methyl-pyrrolidone. The Committee invites all stakeholders (e.g. veterinary healthcare professionals, farmers, academia) to submit data relevant to this procedure by 13 September 2022.
Maximum residue limits
The Committee adopted by majority a positive opinion recommending the extension of the maximum residue limit status for ketoprofen to chickens. Ketoprofen is currently included in Table 1 (Allowed substances) of the Annex to Commission Regulation (EU) No 37/2010 with a ‘No MRL required’ entry for use in bovine, porcine, and Equidae.
Scientific advice
The Committee adopted three scientific advice reports further to two requests for initial advice and one request for a follow-up advice concerning pharmaceutical products. The respective target species were pigs (one product) and dogs (two products).
Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6
Following a request, the CVMP classified a veterinary medicinal product (ATCvet classification: Nervous system) for rodents and rabbits as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
The Committee reviewed an updated request for classification of a veterinary medicinal product (ATCvet classification: Immunologicals) for chickens. The Committee confirmed its previous considerations and classified the product as intended for a limited market according to Article 4(29), but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
Pharmacovigilance
Under Regulation (EU) 2019/6
The Committee endorsed recommendations for changes to the product information for Cerenia and Nasym as an outcome of signal detection activities.
Under Regulation (EC) No 726/2004
The Committee reviewed the PSURs for Aservo EquiHaler and Librela and concluded that changes to their respective product information were required.
Concept papers, guidelines and SOPs
Environmental Risk Assessment
The Committee adopted an updated Questions and Answers document (EMA/CVMP/ERA/172074/2008) on the implementation of the CVMP guideline on environmental impact assessment for veterinary medicinal products in support of VICH guidelines 6 and 38.
Regulation (EU) 2019/6
The Committee adopted a draft procedural advice document for vaccine platform technology master file (vPTMF) certification (EMA/CVMP/184591/2022) for a 2-month period of public consultation.
The Committee adopted an updated Questions and Answers document on data requirements for multi-strain dossiers for inactivated vaccines (EMA/CVMP/IWP/466888/2017-Rev.2).
Working parties
The Committee re-elected Dr Frida Hasslung Wikström as chair of the Scientific Advice Working Party (SAWP) for a further 3-year mandate.
Organisational matters
The Committee finalised the agenda of the Presidency CVMP and Joint CVMP/CMDv meetings to be held under the French Presidency of the EU, on 31 May and 1 June 2022. The discussions will focus on lessons learned from 2 years of virtual meetings regarding the functioning of the Committee, stakeholder engagement, managing new risks regarding user risk assessments for ectoparasiticides, and a number of topics related to product availability and ensuring appropriate therapeutic options.
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”.