EMA Guidelines on Veterinary Medicine - open for consultation

30th January 2026

• A Concept paper on the development of a guideline for using owner assessment as efficacy parameter, where it is proposed that guidance is developed to provide clarification on what might be considered an acceptable and appropriate approach to the use of owner assessment as an efficacy parameter for the purpose of demonstrating efficacy of a veterinary medicinal product. Additional information is available on this webpage. The public consultation is open until 30 April 2026.
• The revision 2 of the Guideline on veterinary medicinal products controlling Varroa destructor parasitosis in bees, whose objective is to provide guidance on the demonstration of efficacy and target animal safety of veterinary medicinal products intended for the control of Varroa destructor parasitosis in the honey bees. The guideline is intended for applications for marketing authorisation of new veterinary medicinal products, as well as for variations to already authorised veterinary medicinal products. Additional information is available on this webpage. The public consultation is open until 31 May 2026.
• The revision 1 of the Guideline on the requirements for combined vaccines and associations of immunological veterinary medicinal products (IVMPs). The guideline was revised in order to adapt legal references to the current legislation and reflect the experience that was gained with the current version of the guideline (reference EMA/CVMP/IWP/594618/2010) since it is in force. Additional information is available on this webpage. The public consultation is open until 31 May 2026.
• A new Guideline for the evaluation of efficacy of ectoparasiticides - general requirements replacing the 'Guideline for demonstration of efficacy of ectoparasiticides' (7AE17a) and providing general guidance on the data requirements, the design and conduct of pre-clinical studies and clinical trials to support efficacy for an ectoparasiticidal veterinary medicinal product. Additional information is available on this webpage. The public consultation is open until 22 May 2026.

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