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More information29th July 2026
Summary: The proposed revision will update the guideline to reflect Regulation (EU) 2019/6, current European Commission guidance and the CVMP’s approach to evaluating the benefit-risk balance of veterinary medicines. It will also incorporate experience gained from assessing fixed combination products, with the aim of clarifying requirements and aligning the guidance with current scientific knowledge and regulatory expectations. Comments are invited until 31st October 2026.
Link: https://www.ema.europa.eu/en/fixed-combination-products-scientific-guideline