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News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
Details of the system for reporting adverse drug reactions from medicines or adverse incidents with medical devices in the UK
The review of the safety of isotretinoin has concluded.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Comply with good pharmacovigilance practice and prepare for an inspection.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines
How to write clear and effective field safety notices (FSNs) for medical devices.
This guidance summarises our approach to pharmacovigilance
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Examples of what manufacturers must report to the MHRA under the medical device vigilance system when incidents involving their devices occur in the UK.
E-learning modules for healthcare professionals on minimising the risks of using medicines and information on how to access medical device modules.
Information for patients, healthcare professionals and developers of new medicines
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
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