CVMP opinions on veterinary medicinal products Under Regulation (EU) 2019/6

The Committee adopted the scientific advice on the establishment of a list of antimicrobials which shall not be used in accordance with Articles 112, 113 and 114 of Regulation (EU) 2019/6 or which shall be used in accordance with these articles subject to certain conditions. This advice relates to the implementing act referred to in Article 107(6) of the same regulation (EMA/CVMP/151584/2021). The purpose of this list, together with the list of antimicrobials reserved for human use established under Article 37(5) and enacted under Commission Implementing Regulation (EU) 2022/1255, is to help preserve the efficacy of certain antimicrobials for humans and/or animals by promoting prudent antimicrobial use and thereby reducing the risk from antimicrobial resistance (AMR).

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

  • Eryseng Parvo (worksharing procedure with other related nationally authorised products)
  • Galliprant
  • Mhyosphere PCV ID
  • 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:

  • Cytopoint
  • Easotic
  • Equilis Prequenza (grouped) – including the update of product information sections on adverse events to add the adverse event 'hypersensitivity reaction' with a very rare frequency as outcome of signal management activities
  • Equilis Prequenza Te (grouped) - including the update of product information sections on adverse events to add the adverse event 'hypersensitivity reaction' with a very rare frequency as outcome of signal management activities
  • Equilis Te (grouped) - including the update of product information sections on adverse events to add the adverse event 'hypersensitivity reaction' with a very rare frequency as outcome of signal management activities
  • Nobilis IB 4-91 (grouped) – including addition of information on the onset of immunity and duration of immunity to the product information
  • Prevexxion RN
  • SevoFlo
  • Versican Plus DHPPi
  • Versican Plus DHPPi/L4

Scientific advice

The Committee adopted two scientific advice reports further to requests for initial advice concerning pharmaceutical products for dogs.

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

The CVMP classified a product (ATCvet classification: Alimentary tract and metabolism) for horses as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Concept papers, guidelines and SOPs

Antimicrobials

The Committee adopted a questions and answers document on the guideline on the SPC for Veterinary Medicinal Products (VMPs) containing antimicrobial substances (EMA/CVMP/AWP/933465/2022). The document was drafted in order to provide guidance on the inclusion of clinical breakpoints in the SPC for generic antibiotic VMPs.

The Committee adopted a draft guideline on the reporting of antimicrobial sales and use in animals at the EU level – denominators and indicators (EMA/CVMP/882931/2022), for release for 1-month of public consultation. The document outlines the animal population data that should be reported by Member States and the necessary adjustments, according to so-called denominators, to be made by the Agency for the calculation of population-adjusted volume of sales and of the use of antimicrobials.

Immunologicals

The Committee adopted a draft concept paper for the revision of the guideline on live recombinant vector vaccines for veterinary use (EMA/CVMP/IWP/161133/2023), for release for a 3-month period of public consultation. This concept paper has been developed to address the scientific and regulatory developments since the original “Guideline on live recombinant vector vaccines for veterinary use” (EMEA/CVMP/004/04-FINAL) came into effect on 8 June 2005. The CVMP considers that this guideline should be updated in order to reflect current knowledge and ensure continued relevance for development of commercial veterinary vaccines.

Novel Therapies & Technologies

The Committee adopted a revised guideline on the development and data requirements of potency tests for veterinary cell-based therapy products and the relation to clinical efficacy (EMA/CVMP/NTWP/179287/2022) following the close of the public consultation. The comments received during the consultation procedure have been taken into account for the revision of the guideline. The guideline was developed to provide guidance on the requirements for developing and implementing a suitable potency assay or a combination of assays, which is linked to relevant biological properties of the cell-based product and further linked to the product’s clinical efficacy. The revision will come into effect on 23 June 2023.

Pharmacovigilance

The Committee adopted the following standard lists used for electronic reporting of suspected adverse reactions following the yearly review and update:

  • CVMP combined VeDDRA list of clinical terms for reporting suspected adverse reactions in animals and humans to veterinary medicinal products (EMA/CVMP/PhVWP/10418/2009-Rev.14)
  • List of changesto combined VeDDRA list of clinical terms (EMA/CVMP/PhVWP/218994/2023).

The Committee adopted the revised guidance notes on the use ofVeDDRA terminology for reporting suspected adverse reactions in animals and humans (EMA/CVMP/PhVWP/288284/2007-Rev.15) and the non-current VeDDRA LLT terms and codes (EMA/CVMP/PhVWP/360871/2010). The implementation of the standard lists in EudraVigilance Veterinary is provisionally scheduled for 1 October 2023.

Working parties

The Committee elected Esther Werner as chair of the IWP, for another 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”.

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