CVMP adopts its workplan for 2021 and its strategy on antimicrobials for 2021-2025

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus a positive opinion for a type II variation application for Exzolt (fluralaner) to update the product information regarding the effect of the product on mite-induced stress and animal welfare.

The Committee adopted by consensus positive opinions for type II variation applications concerning quality-related changes for:

  • Cytopoint (grouped)
  • Eravac
  • Gumbohatch
  • Melosus
  • Meloxoral
  • Nobilis IB Primo QX (grouped)
  • Nobilis IB 4-91 (grouped)
  • Varromed (grouped)

Scientific advice

The Committee adopted a scientific advice report further to a request for initial advice which concerned a pharmaceutical product. The target species were cattle, sheep, horses, pigs, dogs and cats.

Minor use, minor species (MUMS)/limited market

Following the Committee’s review of a re-examination request for classification under the MUMS/limited market policy, the CVMP classified a product for dogs (ATCvet classification: Antineoplastic and immunomodulating agents) as intended for a MUMS/limited market and the product is eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as it is intended for use in non-food producing species.

Pharmacovigilance

The Committee reviewed the PSURs for Evant, Pirsue, Respiporc FLU3, Semintra, Stelfonta, Suvaxyn Circo, Suvaxyn PCV and VarroMedand concluded that no further action was required.

Antimicrobials

The Committee adopted the CVMP strategy on antimicrobials for 2021-2025 (EMA/CVMP/179874/2020). The Committee’s activities regarding antimicrobials over the next five years will focus on supporting the effective implementation of those provisions in Regulation (EU) 2019/6 that take forward the EU’s One Health Action Plan against antimicrobial resistance (AMR). Proposed actions address measures embedding the responsible use of antimicrobials in veterinary medicine, the protection of public and animal health from the risk of AMR and support to the development of new antimicrobials and their alternatives. The comments received during the consultation procedure have been considered and were also adopted for publication by the Committee.

Both documents, the CVMP strategy on antimicrobials for 2021-2025 and the comments received during consultation, will be published on the Agency’s website.

Concept papers, guidelines and SOPs

Immunologicals

The Committee adopted a concept paper (EMA/CVMP/IWP/630533/2020) on the development of a guideline on data requirements for authorisation of immunological veterinary medicinal products under exceptional circumstances for release for a 2-month period of public consultation. The concept paper discusses the development of a guideline to clarify data requirements for applications for marketing authorisation for immunological veterinary medicinal products taking into account the provisions in Regulation (EU) 2019/6.

The Committee adopted a concept paper (EMA/CVMP/IWP /674640/2020) on the development of a guideline on data requirements for vaccine antigen master files for release for a 2-month period of public consultation. The concept paper discusses development of a guideline to further clarify the data requirements for vaccine antigen master files specified in Regulation (EU) 2019/6.

The Committee adopted a concept paper (EMA/CVMP/IWP /582191/2020) for the development of a guideline on data requirements for vaccine platform technology master files for release for a 2-month period of public consultation. The concept paper discusses the development of a guideline to define data requirements for vaccine platform technology master files taking into account the provisions in Regulation (EU) 2019/6.

The Committee adopted a concept paper (EMA/CVMP/IWP/600275/2020) for the revision of the guideline on data requirements for multi-strain dossiers for inactivated vaccines against avian influenza, bluetongue and foot and mouth disease for release for a 2-month period of public consultation. The concept paper discusses the changes to be introduced to the existing guideline to bring it in line with the provisions for multi-strain dossiers in Regulation (EU) 2019/6.

The Committee adopted a concept paper (EMA/CVMP/IWP/671155/2020) for the revision of the Note of guidance on veterinary field trials (EMEA/CVMP/852/99-FINAL) and the position paper on indications for veterinary vaccines (EMEA/CVMP/042/97-Rev.1) for release for a 2-month period of public consultation. The concept paper discusses the need to clarify the requirements for field efficacy data in support of marketing authorisation applications for veterinary vaccines and to provide advice on how the efficacy data should be reflected in the summary of product characteristics (SPC).

Organisational matters

The Committee adopted the CVMP work plan for 2021 (EMA/CVMP/553776/2020), which highlights the priority areas for the Committee this year.

The CVMP work plan for 2021 will be published on the Agency’s website.

More information about the above-mentioned medicines, including their full indication, working parties workplans, guidelines, reflection papers, questions and answers and other documents can be found below in “Related content”.

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