CVMP opinions on veterinary medicinal products 

The Committee adopted by consensus a positive opinion for a marketing authorisation application for a vaccine that is effective against the currently circulating strains of highly pathogenic avian influenza (HPAI). Innovax-ND-H5 (turkey herpesvirus, strain HVT-ND-H5 (cell-associated), expressing fusion protein gene of Newcastle disease virus and haemagglutinin gene of avian influenza virus subtype H5, live), from Intervet International B.V, is a new vaccine for the active immunisation of one-day-old chicks or 18–19 day-old embryonated chicken eggs to reduce mortality, clinical signs and virus excretion due to infection with HPAI virus of the H5 type. The positive opinion was adopted under the legal basis of exceptional circumstances.

The Committee adopted by consensus a positive opinion for a marketing authorisation application for RESPIVAC TRT (turkey rhinotracheitis virus, live), from Laboratorios Hipra, S.A., a new vaccine for the active immunisation of chickens to reduce the detrimental effect caused by virulent avian metapneumovirus on the ciliary activity, which may be manifested in respiratory clinical signs.

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

  • Coxatab
  • Coxevac
  • Evant
  • Simparica Trio

The Committee adopted by consensus positive opinions for variations requiring assessment to align the product information with version 9.0 of the QRD template for:

  • Advocate
  • Arti-Cell Forte
  • Convenia
  • Cortavance
  • MS-H vaccine
  • Neoleish – grouped with a variation to add a new pack size
  • NexGard
  • Syvazul BTV
  • Tessie
  • UpCard

Maximum residue limits

Further to a request from the European Commission, the Committee concluded the first phase of a review of its previous opinion on maximum residue limits (MRLs) for ketoprofen in bovine, porcine and Equidae. The CVMP invites all interested parties such as pharmaceutical industry, learned societies, governmental institutions as well as EU and EEA-EFTA Member States to submit scientific data for use in this review on the pharmacokinetics, residue depletion, analytical methods, and monitoring results of ketoprofen. The CVMP is seeking to obtain any relevant data, not already reported in CVMP’s initial summary report, that may be available to address concerns relating to residue concentrations in tissues that may exceed the ADI. Scientific contributions should be sent to: mrl@ema.europa.eu.

Referrals and related procedures

On 14 March 2024, the Committee started a procedure for Kexxtone 32.4 g continuous-release intraruminal device for cattle(monensin) from Elanco GmbH. The matter was referred to the Committee by the European Commission (EC) under Article 130(4) of Regulation (EU) 2019/6 due to deficiencies in the quality of Kexxtone, leading to a potential lack of efficacy in cattle and to reported adverse events in the non-target species dogs. During its April 2024 meeting, the Committee, following an oral explanation by the marketing authorisation holder, discussed the benefit-risk balance of this veterinary medicinal product. The Committee formally adopted an opinion via written procedure on 23 April 2024, in line with the request from the EC, recommending by consensus the suspension of the marketing authorisation and the recall of all batches from the market.*

Scientific advice

The Committee adopted one scientific advice report further to a request for initial scientific advice for a pharmaceutical product intended for the so far unspecified species.

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

Following one request, the CVMP classified a product, ATCvet classification: Respiratory system for cage birds, homing pigeons, terrarium animals, small rodents, ferrets, rabbits, exotic animals and zoo-kept animals, as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Concept papers, guidelines

Antimicrobials

The Committee adopted the Manual for Member States for establishing a data quality management plan for the collection of antimicrobial sales and use data under Regulation (EU) 2019/6 and its delegated and implementing regulations.

Novel Therapies

The Committee adopted a draft concept paper on the development of a guideline on the safety of nanoparticles (EMA/CVMP/NTWP/143787/2023) for release for a 3-month period of public consultation. This concept paper has been developed to address the safety of nanoparticles in the context of the establishment of maximum residue limits and marketing authorisations for veterinary medicinal products.

Quality

The Committee adopted a draft guideline on stability testing for variations for veterinary medicinal products (EMA/CVMP/QWP/515653/2023) to be released for a 3-month period of public consultation. This document provides guidance on the stability data which have to be generated in order to support a variation to a marketing authorisation for veterinary medicinal products. The guideline applies to both variations not requiring assessment (VNRA) and variations requiring assessment (VRA).

The Committee adopted a Q&A document on nitrosamines limits on certificates of suitability (CEPs) for veterinary medicinal products.

The Committee adopted the addendum to the guideline on the use of near infrared spectroscopy (NIRS) by the pharmaceutical industry and the data requirements for new submissions and variations, together with the overview of comments received during the public consultation. This addendum has been developed to define changes that would be considered within the approved scope of the NIRS procedure and therefore maintained under GMP only, versus those changes that would be considered outside of the scope of the procedure and therefore subject to a variation application.

The documents above will be published on the Agency’s website in due course.

Working parties

The Committee re-elected C. Bergman as chair of the Safety Working Party - Veterinary for a further 3-year mandate.

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”.

*The information on the Article 130(4) procedure for Kexxtone was amended on 26 April 2024 to include the CVMP recommendation adopted via written procedure on 23 April 2024.

How useful do you find this page?