Veterinary Medicines

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    VM4: Practical implementation of the Union Product Database


    This session looked at one of the main elements of the practical implementation of Regulation 2019/6, which is the creation of a Union Product Database (UPD).

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    VM1: Regulatory science – focus on biologicals


    Opening the session, Ivo Claassen spoke about the unprecedented situation of the COVID-19 pandemic and the effects it has had on regulatory adaptation and emergency response preparedness. It was remarkable that novel mRNA vaccines for humans were developed and licensed in such a short period. He believes that there will be a considerable impact on the regulatory landscape in the long term.

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    VM2: Encouraging specific investments


    Session 2 co-chaired by Beate Lohr and Emily Drury looked into specific opportunities opened up by the Veterinary Medicines Regulation intended for limited markets (Article 23) and for gaining additional data protection through defined post-authorisation product developments (Article 40(5)).

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    VM5: Post-authorisation under Regulation 2019/6


    Dries Minne opened the final session of the Veterinary Medicines Symposium 2021, covering changes to post authorisation procedures under Regulation 2019/6.

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    VM3: Regulation 2019/6 on antimicrobials; requirements and availability


    During the session, the speakers presented an overview of the new and revised rules and guidance, explored the major hurdles for new AMs, and discussed how we can protect existing AMs on the market through measures such as harmonisation of summaries of product characteristics (SPC) and flexible dosing labels.