2022-12-05T00:05:00+00:00By Rhona Banks
The requirements for quality data for LM products have increased under the new Regulation. It is difficult to determine which regulatory framework is most appropriate for novel ATMs.
2022-12-05T00:04:00+00:00By Mel Munro
The new EU Veterinary Medicines Regulation contains specific provision for novel therapies. Established methodologies for demonstrating quality, safety and efficacy of veterinary medicinal products often cannot be applied to novel therapies.
2022-12-05T00:03:00+00:00By Beate Lohr
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.
2022-12-05T00:02:00+00:00By Kornelia Grein
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.
2022-12-05T00:01:00+00:00By Pascale Canning
The 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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