The European Medicines Agency (EMA) has published a revised guideline on data requirements to support in-use stability claims for veterinary vaccines, updating references to align with Regulation (EU) 2019/6 on veterinary medicinal products. The revision, adopted by the Committee for Medicinal Products for Veterinary Use (CVMP) on 16 July 2026 and published on 24 July 2026, makes administrative changes only, with no alterations to scientific content. The guideline will come into effect on 16 January 2027.
The revised document replaces the original guideline adopted in March 2010, which came into effect in October 2010. The update was agreed by the Immunologicals Working Party (IWP) on 22 April 2026 before CVMP adoption. According to EMA, no concept paper or public consultation was deemed necessary because the scientific content remains unchanged. The revision updates references to the applicable legislation and other scientific guidelines to reflect the new legal framework under Regulation (EU) 2019/6, which replaced earlier directives.
The guideline covers data requirements for demonstrating in-use stability of veterinary vaccines, including potency testing and microbial safety. It provides general concepts and study design principles for manufacturers seeking to claim an in-use shelf-life after opening or reconstitution of a vaccine. The document applies to all veterinary vaccines and aims to ensure consistent data generation across the EU.
Stakeholders affected include veterinary vaccine manufacturers, who must comply with the updated references when submitting marketing authorisation applications or variations. National competent authorities and EMA assessors will use the guideline as a reference for evaluating in-use stability data. The revision does not impose new scientific requirements, so manufacturers already following the original guideline should not face additional testing burdens. However, they will need to ensure that their dossiers reference the correct legal basis under Regulation 2019/6.
No further institutional follow-up is expected, as the guideline is immediately applicable for new submissions and will become mandatory for all applications after the coming-into-effect date.