The European Medicines Agency (EMA) has unveiled a new guideline to standardize stability data requirements for veterinary medicines under European Regulation 2019/6. This comprehensive document aims to clarify the procedures and data necessary for marketing authorization variations and will come into effect on June 1, 2025.

The guideline distinguishes between Variations Not Requiring Assessment (VNRA) and Variations Requiring Assessment (VRA), applying to all veterinary medicines except for biological, immunological, and biotech products. It extends existing CVMP and VICH guidelines to address the unique requirements of veterinary medicines, offering detailed instructions on stability testing for active ingredients and finished products.

Flexibility in approach

While the guideline outlines standard expectations, it acknowledges alternative methods, such as quality-by-design-based approaches, provided they are justified. Testing methodologies like bracketing, matrixing, or accelerated condition testing are also encouraged, following VICH GL45. This new framework is set to streamline the process, ensuring transparency and consistency while maintaining the safety and quality of veterinary medicines.

For further details, visit EMA’s official webpage.