All Regulatory Rapporteur articles in December 2022 – Page 2
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JournalVM3: Antimicrobials; the new rules, their impact and consequences
The Veterinary Regulation 2019/6 established new provisions and obligations for antimicrobials in veterinary medicines. Work on implementing regulations and guidelines is ongoing to further specify their use and restrictions.
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JournalVM4: 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 ReportVM5: 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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