High attendance at Veterinary Medicines Info Day ahead of implementation of new EU Regulations

Hosted by the European Medicines Agency with the support of AnimalhealthEurope, the Veterinary Medicines Info Day welcomed a record number of participants to the reformulated online event, as the veterinary medicine sector enters the final transition year before new EU Regulations (2019/6 and 2019/4) become applicable on 28 January 2021.

This popular annual event for the sector was cancelled at short notice in 2020, but is back with a vengeance in 2021, with a quintupled audience of around 800 participants (1000+ people registered). Participants were keen to follow the main theme for the event, focusing on the activities in preparedness for compliance with the new Regulations. The programme also included the latest updates on regulatory policy, scientific and procedural developments.

The EMA’s Executive Director, Emer Cooke opened the event with encouraging words:

“The European Medicines Agency is fully committed to supporting industry in implementing the new EU Regulation. We are fully aware that many animal health companies are SMEs and one of the aims of the new legislation is to reduce administrative burden. This will also help with the aim of encouraging further innovation in order to better manage and treat animal diseases.”

EMA representatives shared important information on implementation activities, including the necessary IT systems updates and the implications for industry. And AnimalhealthEurope speakers shared company perspectives on preparedness.

The event included presentations on both the activities of the CVMP and the work of the CMDv relating to new and revised guidance and procedures in preparation for the new Regulations. In addition, there was a keen focus on pharmacovigilance, for which there will be new signal detection and surveillance systems and procedures, and on antimicrobials, for which there are several new rules to comply with.

Eva Zamora, Head of Unit for animal nutrition and veterinary medicines under the Directorate General for Health at the European Commission highlighted that work to implement the new Regulation will not stop after 28 January 2021. She presented the on-going work plan of the European Commission on the new Regulation “2022 and beyond”.

In parallel to the implementation of the new Regulation, the EU Medicines Regulatory Network is also implementing the Regulatory Science Strategy and European medicines agencies network strategy to 2025. EMA activities to implement the strategy and industry priorities were discussed in this respect.

Ivo Claassen Head of the Veterinary Medicines Division at the EMA closed the event saying:

“We have seen some very dense information transmitted today on the numerous updates and changes. This shows the enormous amount of work done within the regulatory network and together with industry stakeholders to ensure a more efficient process for the veterinary medicines sector. We hope this will help industry in preparation to apply the new Regulations.”

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