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The home of Medicines and Healthcare products Regulatory Agency on GOV.UK. The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK.
Find alerts and recalls issued by MHRA
GlaxoSmithKline UK Ltd have informed the MHRA that an incorrect version of the Summary of Product Characteristics section 4.2 and the Patient Information Leaflet is inside the sealed pack, and contains unapproved text.
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
Summary List of field safety notices (FSNs) from medical device manufacturers from 02 to 06 May 2022
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Quadrant Pharmaceuticals Ltd are recalling a specific batch of Mefenamic Acid 500mg Film-Coated Tablets as a precautionary measure, due to observations of a defective layer of film coating in some tablets, resulting in the t…
Summary List of field safety notices (FSNs) from medical device manufacturers from 09 to 13 May 2022
A weekly report covering adverse reactions to approved COVID-19 vaccines
Find drug safety updates issued by MHRA
Consumer advice and details of how to report problems with e-cigarettes with guidance on how to place an e-cigarette on the market in Great Britain and Northern Ireland, including the notification scheme.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Public list of companies in the UK who have had their licence/registration to manufacture or wholesale medicines/ingredients revoked or suspended.
A new study has suggested pregabalin may slightly increase the risk of major congenital malformations if used in pregnancy. Patients should continue to use effective contraception during treatment and avoid use in pregnancy …
The vaccine has been approved after meeting the required safety, quality and effectiveness standards.
It is the first treatment approved by the UK regulator that has been made possible through the Access Consortium ‘New Active Substance Work Sharing Initiative’.
Pfizer Limited are recalling all batches of Accupro 5mg, 10mg, 20mg, 40mg film-coated tablets as a precautionary measure
Guidance for industry and organisations to follow from 1 January 2021.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor the Commission on Human Medicines.
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