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

Current version – effective from 28/01/2022

Guideline on clinical trials with immunological veterinary medicinal products

AdoptedReference Number: EMA/CVMP/IWP/260956/2021Legal effective date: 28/01/2022

Document history - Revision 1

Draft guideline on clinical trials with immunological veterinary medicinal products

Draft: consultation closedConsultation dates: 23/07/2021 to 29/10/2021Reference Number: EMA/CVMP/IWP/260956/2021

Overview of comments received on the draft guideline on clinical trials with immunological veterinary medicinal products (IVMPs) (EMA/CVMP/IWP/260956/2021)

Reference Number: EMA/CVMP/IWP/618327/2021

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

Draft: consultation closedConsultation dates: 29/01/2021 to 31/03/2021Reference Number: EMA/CVMP/IWP/671155/2020

Note for guidance: Field trials with veterinary vaccines

AdoptedReference Number: EMEA/CVMP/852/99-FINALLegal effective date: 01/12/2001