Fixed combination products - Scientific guideline

The CVMP guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005) was initially adopted in December 2006. The last revision (Rev.1) was carried out in July 2021, with the purpose to implement administrative changes to update the guideline with the new definitions and terminology provided by Article 4 of Regulation (EU) 2019/6.
This concept paper addresses the need for a more thorough revision of the guideline, in line with Regulation (EU) 2019/6, the European Commission’s Guidance to Applicants (C/2024/1443) and the CVMP guideline on the evaluation of the benefit-risk balance of veterinary medicinal products (EMA/CVMP/248499/2007-Rev.1). It also takes into consideration the experience gained in the assessment of data for fixed combination veterinary medicinal products. This experience has highlighted the need for further clarification and updating of certain aspects of the guideline to ensure alignment with current scientific knowledge and regulatory requirements.

Keywords: Veterinary medicinal products, fixed combinations, pharmaceuticals, combination packs

Current version - effective from 28/01/2022

Guideline on pharmaceutical fixed combination products - Revision 1

Adopted Reference Number: EMA/CVMP/83804/2005-Rev.1 Legal effective date: 28/01/2022

Concept paper

Concept paper on the revision of the guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005-Rev.1)

Draft: consultation open Consultation dates: 24/07/2026 to 31/10/2026 Reference Number: EMA/CVMP/EWP/54206/2026 Summary:

The CVMP guideline on pharmaceutical fixed combination products (EMA/CVMP/83804/2005) was initially adopted in December 2006. The last revision (Rev.1) was carried out in July 2021, with the purpose to implement administrative changes to update the guideline with the new definitions and terminology provided by Article 4 of Regulation (EU) 2019/6.
This concept paper addresses the need for a more thorough revision of the guideline, in line with Regulation (EU) 2019/6, the European Commission’s Guidance to Applicants (C/2024/1443) and the CVMP guideline on the evaluation of the benefit-risk balance of veterinary medicinal products (EMA/CVMP/248499/2007-Rev.1). It also takes into consideration the experience gained in the assessment of data for fixed combination veterinary medicinal products. This experience has highlighted the need for further clarification and updating of certain aspects of the guideline to ensure alignment with current scientific knowledge and regulatory requirements.

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Document history

Guideline on pharmaceutical fixed combination products

Adopted Reference Number: EMEA/CVMP/83804/2005 Legal effective date: 01/07/2007

Questions and answers on the CVMP guideline on pharmaceutical fixed combination products (EMEA/CVMP/83804/2005)

Reference Number: EMA/CVMP/EWP/325284/2011 Rev.1

Overview of comments received on draft guideline on pharmaceutical fixed combination products

Reference Number: EMEA/CVMP/463526/2006