The European Medicines Agency (EMA) has proposed a revision of its guideline on pharmaceutical fixed combination products for veterinary use, aiming to align the scientific content with Regulation (EU) 2019/6 and the European Commission's Guidance to Applicants. The concept paper, published on 24 July 2026, identifies the need for further clarification and updating of certain aspects of the guideline to reflect current scientific knowledge and regulatory experience.
The current guideline, initially adopted in December 2006 and last revised in July 2021, outlines conditions and data requirements for efficacy, safety, and residues documentation for veterinary medicinal products containing two or more active substances. The revision seeks to address sections that are liable to misinterpretation, particularly Section 6 on dossier requirements for combination products. The inclusion of meaningful examples is proposed to aid consistent application and prevent confusion for applicants and regulators.
The concept paper also notes that the existing 'Questions and answers on the CVMP guideline on pharmaceutical fixed combination products' document contains important clarifications on specific antiparasitic fixed combination products, which should be considered in the revised guideline. The revision will take into account the 3Rs principles (replacement, reduction, and refinement) and ensure alignment with other relevant CVMP guidance documents, such as the revised guideline on benefit-risk balance and user safety.
The public consultation on the concept paper runs until 31 October 2026. Comments should be submitted using the provided template to vet-guidelines@ema.europa.eu. The proposed guideline will replace the current version (EMA/CVMP/83804/2005-Rev.1).