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The new guidance outlines the approach the MHRA intends to take for products approved or pending in a decentralized procedure or mutual recognition procedures.
The Medicines and Healthcare products Regulatory Agency (MHRA) updated its guidance concerning decentralized procedure (DCP) and mutual recognition procedures (MRP) on June 24, 2022. The guidance details how MHRA handles products already approved or pending in ongoing DCPs and MRPS, while the new updates detail how to convert a Great Britain Product Licenses (GBPL) or Northern Ireland (PLNI) license to a UK-wide license.
The update concerning GBPL and PLNI excludes products that are already the subject of an EU Community Marketing authorization in Northern Ireland or those that fall within the mandatory scope of the European Medical Agency’s centralized procedure. A full breakdown of the updated guidelines can be found on the MHRA site.