All Symposium 2022 articles – Page 2
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Journal
VM4: Regulatory update and perspectives: Variations, packaging and labelling, pharmacovigilance
Industry is navigating through complex new rules and opportunities for variations and will require continued cooperation. The year 2023 is expected to show the benefits of the revised pharmacovigilance procedures in practice.
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Meeting Report
VM5: CVMP Guidelines Update:
Data protection (Article 40.5),
prescription status (Article.34) and benefit-riskThe secondary legislation and guidelines are as critical as Regulation 2019/6 itself in defining the future landscape for animal health in the EU. The concept and definitions of benefit-risk affect many different aspects of veterinary medicines regulation, as per the legislation.
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