CVMP opinions on veterinary medicinal products

The Committee adopted by majority a positive opinion for a marketing authorisation application for Felpreva (tigolaner / emodepside / praziquantel), from Vetoquinol S.A., a new product for cats with, or at risk from, mixed parasitic infestations.

The Committee adopted by consensus a positive opinion for a type II variation application for Frontpro concerning a change of legal status from prescription-only to non-prescription veterinary medicine.

The Committee adopted by consensus a positive opinion for a grouped type II variation application for Porcilis PCV ID to change the product information to add an indication on associated mixed-use with Porcilis Lawsonia ID, and to broaden the target species category from fattening pigs to pigs.

The Committee adopted by consensus a positive opinion for a type II variation application for Poulvac E. coli to change the product information to highlight that the safety of Poulvac E. coli has been demonstrated when administered to chickens during lay.

The Committee adopted by consensus a positive opinion for a type II variation application (subject to a work-sharing procedure) for Circovac to change the product information to add the associated mixed use with other related nationally authorised products and to extend the duration of immunity to 23 weeks in case of mixed use.

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

  • Innovax-ND-IBD
  • Innovax-ILT and Innovax-ND-IBD (work-sharing grouped procedure)
  • Locatim
  • Prevomax (grouped)
  • ProZinc
  • Startvac (grouped)

Withdrawal of applications

The Committee was informed of the formal notification from MSD Animal Health of their decision to withdraw the type II variation application for a new therapeutic indication against sand flies (Phlebotomus perniciosus) for Bravecto chewable tablets for dogs. More information about this type II variation application and the state of the scientific assessment at the time of the withdrawal will be made available in a public assessment report. The report, together with the withdrawal letter from the applicant, will be published on the Agency’s website in due course.

Renewals of marketing authorisations

The Committee adopted by consensus positive opinions for the renewal of the marketing authorisations for Coliprotec F4/F18 and Cepedex. The Committee, having re-assessed the benefit-risk balance of these products, concluded that the quality, safety and efficacy continue to be appropriately demonstrated and, therefore, recommended the renewal of the marketing authorisations.

Scientific advice

The Committee adopted one scientific advice report further to a request for initial advice which concerned an immunological product. The target species was salmon.

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: ophthalmologicals) for dogs as indicated for MUMS/limited market and 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 adopted a recommendation for changes to the summary of product characteristics for Vepured as an outcome of signal detection activities.

The Committee also reviewed the PSURs for Forceris, Meloxidolor and Reprocyc ParvoFLEX and concluded that no further action was required.

Concept papers, guidelines and SOPs

Environmental Risk Assessment

The Committee adopted a draft reflection paper on the interpretation of Article 18(7) of Regulation (EU) 2019/6 (EMA/CVMP/ERA/622045/2020) for a 3-month period of public consultation. 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.

The Committee adopted a reflection paper on higher tier testing to investigate the effects of parasiticidal veterinary medicinal products on dung fauna (EMA/CVMP/ERA/87473/2021). The comments received during the public consultation on the draft "Guideline on the higher tier testing of veterinary medicinal products to dung fauna" (EMA/CVMP/ERA/409350/2010) have been taken into account for the drafting of the reflection paper. This reflection paper has been developed to address the concern and potential risk towards dung fauna associated with the use of parasiticides in livestock.

Immunologicals

The Committee adopted a revised 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 Rev. 1) following the close of the public consultation. The comments received during the consultation procedure have been taken into account for the revision of the reflection paper.

Regulation (EU) 2019/6

The Committee adopted the following documents related to the guidelines published in July 2021 on limited markets under Regulation (EU) 2019/6:

  • Overview of comments on guideline on safety and residue data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/148001/2021)
  • Overview of comments on guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets submitted under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/147926/2021)
  • Overview of comments on guideline on data requirements for applications for immunological veterinary medicinal products intended for limited markets applications submitted under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/147910/2021)

Organisational matters

The Committee finalised the preparation of the Presidency CVMP meeting to be held under the Slovenian Presidency of the EU, on 13 October 2021. The meeting will focus on potential claims and data requirements for alternatives to antimicrobials, and potential for environmental impact from antiparasiticide use in companion animals.

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”.

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