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CVMP opinions on veterinary medicinal products

The Committee adopted a positive opinion on a marketing authorisation from Elanco for Lotilaner / Milbemycin Elanco (lotilaner / milbemycin oxime), for use in dogs with, or at risk from, mixed infestations/infections by ticks, fleas, mites, gastrointestinal nematodes, heartworm and/or lungworm.

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

• Arti-Cell Forte
• Improvac and NAPs (WS) (worksharing procedure)
• Librela / Equip WNV / Suvaxyn CSF Marker / Suvaxyn Circo+MH RTU / Cytopoint / Suvaxyn Circo / Suvaxyn PRRS MLV / CircoMax / CircoMax Myco/Solensia and NAPs (worksharing procedure)
• Purevax RCPCh  / Purevax RCPCh FeLV (worksharing procedure)
• Strangvac
• Vectormune ND/Vectormune HVT-AIV/Newflend ND H9/Ultifend ND IBD (worksharing procedure)
• Versican Plus DHPPi/L4R / Versican Plus DHPPi/L4 / Versican Plus DHPPi / Versican Plus Pi / Versican Plus Pi/L4R / Versican Plus Pi/L4 (worksharing procedure)

Re-examinations of marketing authorisations in exceptional circumstances

The Committee adopted an opinion on the re-examination of Bluevac-3, a Bluetongue virus vaccine (inactivated). The Committee recommended the extension for one year of the validity of the marketing authorisation in exceptional circumstances.

Scientific advice

The Committee adopted two scientific advice reports for pharmaceutical products for dogs and cats (one product each).

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

The CVMP classifieda product (ATCvet classification: musculoskeletal system) for horses, as intended for a limited market and not eligible for authorisation under Article 23 of Regulation (EU) 2019/6.

Concept papers, guidelines

Efficacy

The Committee adopted a draft revised guideline for the evaluation of efficacy of ectoparasiticides – general requirements (EMA/CVMP/EWP/507106/2023) for a 4-month period of public consultation. This guideline has been developed to provide general guidance on the demonstration of efficacy of ectoparasiticidal veterinary medicinal products and is intended to replace the ‘Guideline for demonstration of efficacy of ectoparasiticides’ (7AE17a).

The Committee adopted a draft revised guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees (EMA/CVMP/EWP/459883/2008-Rev.2) for a 4-month period of public consultation. This guideline has been developed to provide guidance on the demonstration of efficacy and target animal safety for veterinary medicinal products intended for the control of Varroa destructor parasitosis in honeybees.

The Committee adopted a concept paper on the development of a guideline for using owner assessment as an efficacy parameter (EMA/CVMP/EWP/364649/2025) for a 3-month period of public consultation. The objective of the envisaged guideline will be to provide a framework for owner-assessed parameters used to support the demonstration of efficacy for veterinary medicinal products.

Immunologicals

The Committee adopted a revised guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs) (EMA/CVMP/IWP/365787/2025-Rev.1) for a 4-month period of public consultation. This guideline was revised to adapt legal references to the current legislation and reflect the experience that was gained since it is in force. In addition, new approaches in vaccine development and alternative approaches to assess the absence of immunological interference in the associated use of vaccines are considered in the revision.

The Committee adopted three other revised Guidelines to align with Regulation (EU) 2019/6:

• Guideline on environmental risk assessment for immunological veterinary medicinal products (EMEA/CVMP/074/95–Rev.1)
• Guideline on user safety for immunological veterinary medicinal products (EMA/CVMP/1197/2026–Rev.1)
• Guideline on the design of studies to evaluate the safety and efficacy of fish vaccines (EMA/CVMP/1197/2026–Rev.1)

Quality

The Committee adopted questions and answers on the following topics:

• Titanium dioxide (revision)
• Co-processed excipients (new)
• ‘How to use a CEP’ (revision)
• Questions and answers on quality: Part 1 and Part 2 to align with the Commission’s new Guidelines for variation of human medicinal products, and to align with the veterinary legislation.

The questions and answers above will be published on the Agency’s website after their adoption by the CHMP, which is foreseen for the January meeting.

More information about the above-mentioned medicines (including their full indications), guidelines, reflection papers, questions and answers and other documents, such as overviews of comments received during consultation, can be found below in “Related content”.