CVMP opinions on veterinary medicinal products

The Committee adopted by consensus a positive opinion for a grouping of variations requiring assessment for Metacam (meloxicam), from Boehringer Ingelheim Vetmedica GmbH, to modify the indication for use in cats for Metacam 5 mg/ml solution for injection for dogs and cats and to amend the product information for Metacam 5 mg/ml solution for injection for dogs and cats, Metacam 2 mg/ml solution for injection for cats, and Metacam 0.5 mg/ml oral suspension for cats and guinea pigs with regard to the follow-up oral treatment after initial injectable administration in cats.

The Committee adopted by consensus positive opinions for variations requiring assessment concerning quality-related changes for:

  • Fevaxyn Pentofel/Suvaxyn CSF Marker/Suvaxyn PRRS MLV (subject to worksharing)
  • Rexxolide

Union referrals and related procedures

The Committee concluded the follow-up assessment procedure of the conditions on the marketing authorisations for veterinary medicinal products containing moxidectin to be administered orally, topically or subcutaneously to cattle, sheep and horses (EMEA/V/A/116) that had been imposed with Commission Implementing Decision (C(2017) 6577) of 25 September 2017 in the context of a referral procedure under Article 35 of Directive 2001/82/EC for the aforementioned products. The Committee adopted by consensus a follow-up assessment report concluding that no further information on risks to the environment of moxidectin was identified during this follow-up assessment which would lead to a change in the CVMP conclusions from the initial phase of the referral procedure on the benefit-risk balance of the concerned products. Therefore, the CVMP recommended the maintenance of the marketing authorisations (no changes) for the above mentioned veterinary medicinal products.

Scientific advice

The Committee adopted two scientific advice reports further to requests for initial advice concerning one pharmaceutical product and one biological product, for dogs and cats, respectively.

Limited market classifications and eligibility according to Article 23 of Regulation (EU) 2019/6

Following one request, the CVMP classified a product (ATCvet classification: Genito urinary system and sex hormones) for cats as not intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Concept papers, guidelines and SOPs

Quality

The Committee adopted a question-and-answer on how to use a Certification of Suitability (CEP) in the context of a Marketing Authorisation Application (MAA) or a Marketing Authorisation Variation to clarify required data to be submitted in a MAA or in certain variations when a CEP is referred to in the marketing authorisation dossier. It is also applicable to excipients covered by a CEP that are used as an active substance.

The Committee adopted a question-and-answer on the assessment of the quality of finished products containing known active substances which addresses the quality data needed for assessment of known active substances, expectations in terms of the level of impurities and how to address an impurity above the qualification threshold of VICH GL11.

Safety

The Committee adopted a guideline on determination of the need for an MRL evaluation for chemical-unlike biological substances (EMA/CVMP/SWP/591282/2021) and the overview of comments on the guideline (EMA/CVMP/244888/2022) following the closure of public consultation. The development of this guideline was triggered by Regulation (EU) 2018/782. The comments received during the consultation procedure were taken into account for the revision of the guideline. The guideline will come into effect on 1 August 2024.

Efficacy

The Committee adopted a draft revised guideline on data requirements for veterinary medicinal products for zootechnical purposes (EMA/CVMP/EWP/37280/2023) for release for a 4-month period of public consultation. The purpose of this revised guideline is to provide more detailed guidance regarding data requirements for the conduct of pre-clinical studies and clinical trials for veterinary medicinal products for zootechnical purposes and to provide harmonised guidance for the inclusion of information on hormonal protocols to the product information of such products.

Immunologicals

The Committee adopted a guideline on plasmid DNA vaccines for veterinary use (EMA/CVMP/IWP/365817/2022) and the overview of comments received during public consultation (EMA/CVMP/IWP/303516/2023) following the close of the public consultation. This guideline has been developed to provide advice to manufacturers seeking marketing authorisation for nucleic acid vaccines for use in animals when the vaccine consists of (a) bacterial or a synthetic DNA plasmid(s). It applies to DNA vaccines - consisting of plasmid DNA non-amplifiable in eukaryotic cells. The comments received during the consultation procedure have been taken into account in the revision of the guideline. The guideline will come into effect on 17 July 2024.

The Committee adopted a draft, revised guideline on live recombinant vector vaccines for veterinary use (EMA/CVMP/IWP/390313/2023) for a 4-month period of public consultation. This guideline has been developed to advise on the data to be presented in applications for a marketing authorisation of live recombinant vector vaccines, taking into account their particular properties.

Working parties

The Committee elected Damien Bouchard as chair of the AWP for a 3-year mandate.

Organisational matters

The Committee adopted the work plans for 2024 for the CVMP Working Parties: AWP (EMA/CVMP/AWP/381708/2023), EWP-V (EMA/CVMP/EWP/431047/2023), ERAWP (EMA/CVMP/ERA/435515/2023), ESUAvet (EMA/CVMP/ESUAVET/280853/2023), IWP (EMA/CVMP/IWP/444036/2023), NTWP (EMA/CVMP/NTWP/425065/2023), PhVWP (EMA/CVMP/PhVWP/281676/2023), SWP-V (EMA/CVMP/SWP/425226/2023), SAWP-V (EMA/CVMP/SAWP/427324/2023), 3RsWP (EMA/576362/2023), as well as the work plan for the triennium 2024-2026 for QWP.

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”.

How useful do you find this page?

Average: