Icelandic is available via eTranslation, the European Commission's machine translation service.
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Date
Staðsetning
The workshop covers the changes that have been proposed by EMA, with Member State national competent authorities and the European Commission, in line with the new pharmaceutical legislation, and considering the learnings from the 2025 Shortage Prevention Plan (SPP) and Shortage Mitigation Plan (SMP) pilot.
This workshop follows a consultation with industry associations, to gather feedback on the proposed updated template and guidance and planned next steps.
Participants receive an overview of changes, the timeline and the data elements that companies will need to provide upon request from regulatory authorities, in accordance with the upcoming legislation. Dedicated interactive sessions allow participants to raise questions and provide feedback.
The workshop is aimed at nominated participants from eligible industry associations. The European Commission, National Competent Authorities and EMA also attend.
Registration is by invitation only.