Guideline on clinical trials with immunological veterinary medicinal products - Scientific guideline
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
Draft guideline on clinical trials with immunological veterinary medicinal products (PDF/285.54 KB)Draft: consultation closed
First published: 23/07/2021
Consultation dates: 23/07/2021 to 29/10/2021
Overview of comments received on the draft guideline on clinical trials with immunological veterinary medicinal products (IVMPs) (EMA/CVMP/IWP/260956/2021) (PDF/429.82 KB)
First published: 28/01/2022
Draft concept paper on the provision of field efficacy studies in support of marketing authorisation applications for immunological veterinary medicinal products and on indications for veterinary vaccines (PDF/198.71 KB)Draft: consultation closed
First published: 29/01/2021
Consultation dates: 29/01/2021 to 31/03/2021
Note for guidance: Field trials with veterinary vaccines (PDF/48.76 KB)Adopted
First published: 01/06/2001
Last updated: 01/06/2001
Legal effective date: 01/12/2001