Compliance Monitor (CM) Overview and Application Process

15 June 2022 — MHRA published updated guidance on the eligibility of the compliance monitor.

From April 2022, the MHRA will be running a pilot scheme to monitor companies that fail to comply with Good Manufacturing Practice (GMP) and Good Distribution Practice (GDP) protocols and are referred to the Inspection Action Group (IAG) following an inspection that has resulted in the initiation of a compliance process.

Companies that enter the pilot scheme will use consultant(s) selected from the MHRA CM register to monitor the implementation of an agreed upon Compliance Protocol (CP). The ability to act as a CM will be based on the principles of eligibility and suitability, which now includes residence in the United Kingdom.

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