Guidance on Handling of Decentralized and Mutual Recognition Procedures Which are Approved or Pending

24 June 2022 — MHRA published updated guidance on the approach the MHRA intends to take for products approved or pending in decentralized procedure (DCP) or mutual recognition procedures (MRP).

This guidance describes the approach the MHRA intends to take for products already approved or that are included in ongoing DCPs or MRPs with UK in respect of NI (UK(NI)) as a Concerned Member State (CMS).

The section 'Guidance for The Conversion of PLGB or PLNI licenses to PL' was newly added.

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