Committee for Medicinal Products for Veterinary Use (CVMP) meeting of 21-23 April 2020

Press release 24/04/2020

CVMP adopts concept paper on environmental risk assessment for parasiticide veterinary medicinal products used in companion animals

CVMP opinions on veterinary medicinal products

The Committee adopted by consensus positive opinions for type II variations applications for Meloxidyl (meloxicam) and Imrestor (pegbovigrastim) concerning quality-related changes.

The Committee also adopted by consensus a positive opinion for a type II variation application for Bravecto (fluralaner) to lower the minimum age of target animals.

More information about the above-mentioned medicines, including their full indication, will be published on the Agency’s website.

Withdrawal of applications

The Committee was informed of the formal notification from Emdoka bvba of their decision to withdraw the application for an initial marketing authorisation for Tulatrixx. More information about this application and the current state of the scientific assessment at the time of the withdrawal, 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 Novaquin and Upcard. 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.

Maximum residue limits

The Committee agreed to include a nonwoven polyester fabric and polyethylene as new entries in the list of substances considered as not falling within the scope of Regulation (EC) No 470/2009 under the heading of excipients and adopted a revised list (EMA/CVMP/519714/2009-Rev. 43). This decision followed the Committee’s review of the requests that had been submitted in accordance with the relevant CVMP guidance.

The document will be published on the Agency’s website.

Scientific advice

The Committee adopted five scientific advice reports further to requests for:

Minor use, minor species (MUMS)/limited market

Following the Committee’s review of four requests for classification under the MUMS/limited market policy, the CVMP classified:

  • An antineoplastic product 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.
  • An immunological product for turkeys and pheasants as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as the market is not limited.
  • An immunological product 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.
  • An immunomodulating product for dogs as not indicated for MUMS/limited market and not eligible for financial incentives.

The Committee also reclassified an immunological product for rabbits as indicated for MUMS/limited market and eligible for reduced data requirements, where applicable. The product is not eligible for financial incentives as authorised immunological products already exist for the indication.

Pharmacovigilance

The Committee reviewed the PSURs for Baycox Iron, Improvac, Respiporc FluPan H1N1, SevoFlo, Zeleris and Suvaxyn Circo+MH RTU, and concluded that no further action or changes to their product information were required.

Concept papers, guidelines and SOPs

Environmental Risk Assessment

The Committee adopted a new concept paper on the environmental risk assessment for parasiticide veterinary medicinal products used in companion animals (EMA/CVMP/ERA/55512/2020) for a 6-month period of public consultation. The aim is to develop a reflection paper which will consider the state of knowledge on the emission into the environment of such products, the potential risks for the environment, the approach to environmental risk assessment and the need and feasibility of measures to mitigate any risks identified.

The document will be published on the Agency’s website.

Pharmacovigilance

The Committee adopted the public bulletin on veterinary pharmacovigilance for 2019 summarising the Agency’s activities regarding pharmacovigilance for veterinary medicinal products during the past year (EMA/CVMP/PhVWP/33617/2020) in March 2020. The Committee endorsed the release of an additional document (EMA/112926/2020) that will contain the periodically updated list of regulatory actions agreed by the Committee on the basis of pharmacovigilance data (e.g. changes to SPC wording). This document will be kept up to date and published on the Agency’s website after each Committee meeting. Besides the yearly bulletin, this additional document is seen as the next step to improve communication with the general public, including veterinarians, aiming for more regular updates. 

Organisational matters

The EMA Management Board, at its meeting on 19 March 2020, adopted amendments to the existing Rules of Procedure of EMA’s scientific committees and Management Board. The amendments (including introduction of proxy voting and introduction of virtual meetings) were required to enable the Committee to continue its work in a virtual setting in case of emergency, as well as to ensure the validity of the various output decisions that the Committee will adopt. The Committee adopted the amendments to the CVMP Rules of Procedure (EMA/MB/47098/2007–Rev.2), as adopted by the EMA Management Board, and this document will be published on the Agency’s website.

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