TOPRA Symposium gathered together professionals in European regulation affairs in Dublin from September 30 to October 2. Oriola regulatory affairs experts were happy to attend and have interesting discussions with professionals around Europe. One of our experts participating in Topra was our Regulatory Affairs Team Lead Laura Riihimäki-Lampén. Laura and her team help pharmaceutical companies in all matters related to regulatory affairs in the Nordics.
Here are Laura’s key takeaways from Topra:
- The new EU regulation on veterinary medical products was an interesting topic at Topra. One of the most important achievements of the regulation is that it will provide a modern, innovative and fit-for-purpose legal framework on Veterinary Medicinal Product (VMPs) and increase the availability of VMPs. The implementation of the legal process was described, and the work will be done in packages with different timeframes. In the first package, three European union databases will be established (product database, pharmacovigilance database and database on manufacturing, import and wholesale distribution).
- The European Medicines Agency (EMA) presented plans for developing and implementing the new electronic product information (ePI) in the EU and for the publication of “Key principles for ePI in the EU”. A roadmap and timelines for ePI creation and implementation across the EU will be presented in the near future. The first step that needs to be taken is to select a common electronic standard for ePI and develop an ePI creation tool.
- The new Medical device regulation will be fully applicable in May 2020. Discussion about the impact of the new regulation on drug-device combinations took place. EMA is preparing a guideline on quality requirements of medicinal products containing a device component for delivery or use of the medicinal product. EMA also provides a Q&A document on the implementation of the regulations relating to Medical Device and In Vitro Diagnostic Medical Devices and will publish further updates to it. The Q&A covers, for example, information on how the new regulations will impact marketing authorisation applications and strongly recommends that already the initial marketing authorisation will contain an EU certificate, declaration of conformity and notified body opinion.
If you need help in any matters related to regulatory affairs in the Nordics Laura will be happy to talk with you about your needs and our solutions.