Compliance Monitor (CM) Overview and Application Process
OverviewFrom 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) and are…
Chapter 8 – Labelling Guidance Northern Ireland
Submission of notifications for Nothern Ireland under Article 20 of directive 2014/40/EUSeveral queries have been raised with the Department of Health and MHRA, concerning the labelling provisions of the Tobacco…
Chapter 7 – annual reporting guidance Northern Ireland
Information you should include when submitting annual reports on sales of e-cigarette and vape products in Northern Ireland.
Chapter 6 – ingredient guidance Northern Ireland
Information you should include about ingredients when submitting a notification of intent to market e-cigarette and vape products in Northern Ireland.
Medicines shortages: regulatory processes to manage supply disruptions
The Medicines and Healthcare products Regulatory Agency (MHRA) is the UK’s standalone medicines and medical devices regulator.Where there is a potential shortage of supply of a medical product that could…
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