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What are the key elements of the proposal? What is changing? What does it mean for innovators?
The European Commission is due to publish its long-awaited proposal for major revisions to the EU pharmaceutical legislation on Wednesday April 26. If this proposal is published,* our team will provide a rapid first take, covering some of the following hot topics:
- Changes to the incentives for research and innovation, including for orphan and paediatrics medicinal products
- New concepts of unmet medical need, high unmet medical need and significant benefit
- Changes to the regulatory regime for generics and biosimilars
- New obligations in relation to continuity of supply and prevention of shortages
- Rules on repurposing
*The Proposal has been delayed a number of times, so if the documents are not published, we will postpone this webinar.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
