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Procedural advice

  • End of pilot for splitting of MRP/DCPs (May 2020) [Tracked]
  • Decisions on additional year of market protection/data exclusivity for new therapeutic indication agreed by the CMDh (January 2025)

For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI.

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