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Manufacturing Waiver for Medicinal Products

Summary

The proposal introduces a manufacturing waiver allowing EU generic producers to manufacture medicines for export and stockpiling during the supplementary protection period.
10 03.07.2019
Other
health
pharmacy
industry
business and competition

Key points

  • Introduction of a manufacturing waiver for producers of generic and biosimilar medicines within the Union.
  • Permission to manufacture products specifically for export to non-EU countries where protection has expired or does not exist.
  • Allowance for stockpiling medicines to facilitate immediate market entry in the EU once exclusivity ends.
  • Implementation of strict conditions for the waiver, including mandatory notifications to national authorities.
Documents (PDFs)
REPORT on the proposal for a regulation of the European Parliament and of the Council amending Regulation (EC) No 469/2009 concerning the supplementary protection certificate for medicinal products Supplementary protection certificate for medicinal products ***I
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