Guideline on clinical trials with immunological veterinary medicinal products

The main aim of the guideline is to advise on how to perform clinical trials (also called field trials) with immunological veterinary medicinal products (IVMPs) and to address the requirements of the Commission Delegated Regulation (EU) 2021/805 of 8 March 2021 amending Annex II to Regulation (EU) 2019/6 of the European Parliament and of the Council regarding clinical trials for IVMPs. In addition, guidance is provided on when omission of clinical efficacy data may be acceptable.

This guideline replaces the Note for Guidance ‘Field trials with veterinary vaccines’ (EMEA/CVMP/852/99-Final).

Keywords: immunological veterinary medicinal products, clinical trials, safety, efficacy

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