Meeting highlights from the Committee for Veterinary Medicinal Products (CVMP) 11-13 July 2023

14 July 2023

CVMP opinions on veterinary medicinal products

Under Regulation (EU) 2019/6, the Committee adopted, by consensus, a positive opinion for a marketing authorisation for Yurvac RHD, from Laboratorios Hipra, S.A., a new vaccine for the active immunisation of rabbits from 30 days of age onwards to reduce mortality of rabbit haemorrhagic disease (RHD) caused by classical RHD virus (RHDV) and variant strains (RHDV2), including highly virulent strains.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Tessie (tasipimidine) concerning the amendment of the product information with regard to the interactions with other medicinal products.

The Committee adopted by consensus a positive opinion for a grouped variation requiring assessment for NexGard Combo (esafoxolaner/eprinomectin/praziquantel) concerning the addition of two new therapeutic indications for persistent tick killing activity against Ixodes hexagonus and for persistent tick killing activity against Rhipicephalus sanguineus, and aligning the product information with version 9.0 of the QRD template.

The Committee adopted by consensus a positive opinion for a variation requiring assessment for Cimalgex (cimicoxib), amending the adverse reactions sections of the product information to implement the outcome of the MAH’s signal management process.

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

• Apoquel
• CircoMax Myco (grouped)
• Enteroporc Coli AC (grouped)
• Felpreva
• Kexxtone
• Tulaven (grouped)

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:

• Dexdomitor
• Palladia
• Panacur AquaSol
• Porcilis PCV
• RenuTend
• Ypozane
• Zactran
• Zuprevo (grouped) – including an update of a signal management procedure focused on the frequency of anaphylaxis in pigs

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

Following two requests, the CVMP classified:

• A product (ATCvet classification: Antineoplastic and immunomodulating agents) for dogs as intended for a limited market and eligible for authorisation under Article 23 of Regulation (EU) 2019/6.
• A product (ATCvet classification: Antiparasitic products, insecticides and repellents) for honeybees 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 draft concept paper for the development of a reflection paper on the availability and characteristics of diagnostic tests to improve the responsible use of antibiotics in animals (EMA/CVMP/AWP/933451/2022) for a 3-month period of public consultation. This concept paper proposes the development of a reflection paper on diagnostic tests to support the responsible use of antibiotics in animals and is aimed to address activities on this topic that are included in the CVMP’s Strategy on Antimicrobials, the European Medicines Agencies Network Strategy to 2025 and the EMA’s Regulatory Science Strategy.

Efficacy

The Committee adopted a concept paper on the revision of the guideline for the demonstration of efficacy of ectoparasiticides (EMA/CVMP/EWP/56030/2023) for a 3-month period of public consultation. This concept paper has been developed to address the proposed revision of the existing guideline for the demonstration of efficacy of ectoparasiticides (7AE17a) in order to provide clearer guidance and to align the guideline with current scientific and regulatory requirements.

The Committee adopted a draft guideline on efficacy and target animal safety data requirements for applications for non-immunological veterinary medicinal products intended for limited markets but not eligible for authorisation under Article 23 of Regulation (EU) 2019/6 (EMA/CVMP/EWP/231668/2022) for a 6-month period of public consultation.

Immunologicals

The Committee adopted a revised guideline on requirements for the quality (production and control), safety and efficacy of allergen products for use in horses, dogs and cats (EMA/CVMP/IWP/170689/2016) following the close of the public consultation. This guideline lays down the quality recommendations for allergen products of biological origin, including allergen extracts derived from natural source material and allergens produced through recombinant DNA technology, used for immunotherapy treatment or in vivo diagnosis of immunoglobulin E-mediated allergic diseases in horses, dogs and cats. In addition, guidance is given for the clinical testing regarding safety and efficacy of allergen products. The comments received during the consultation procedure were taken into account for the revision of the guideline. The revision will come into effect on 13 January 2024.

Quality

The Committee adopted a revised guideline on excipients in the dossier for application for marketing authorisation for veterinary medicinal products. The current revision consists mainly of administrative changes to align the guideline with Regulation (EU) 2019/6. The revision will come into effect immediately after publication.

The Committee adopted a Question and Answer document on stability of tablet fractions for veterinary medicinal products.

The Committee adopted a Guideline on quality data requirements for applications for veterinary medicinal products other than biologicals intended for limited markets (EMA/CVMP/QWP/47285/2022) to be released for a 6-month period of public consultation.

3Rs

The Committee adopted a letter to Marketing Authorisation Holders of botulinum neurotoxin-containing products, requesting information on animal use in LD₅₀ batch release testing.

Other issues

The Committee adopted a draft reflection paper on the use of Artificial Intelligence (AI) in the medicinal product lifecycle (EMA/83833/2023) for a 6-month period of public consultation. It provides considerations on the use of AI and Machine Learning in the lifecycle of medicinal products, including medicinal products’ development, authorisation, and post-authorisation activities.

Working parties

The Committee elected Marie-Hélène Sabinotto as veterinary vice-chair of the Quality Working Party for a 3-year mandate.

The Committee adopted the 2023/2024 Workplan for the European Sales and Use of Antimicrobials in veterinary medicine Working Group (ESUAvet WG) (EMA/CVMP/280853/2023).

Organisational matters

The Committee finalised the preparation of the informal CVMP and Joint CVMP/CMDv meetings to be held under the Spanish Presidency of the EU, on 21-22 September 2023. The discussions will focus on persistent, bioaccumulative and toxic (PBT) substances, the assessment of 3Rs compliance of non-clinical studies, and products that can contribute to the reduction of the need for antimicrobials.

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".