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Departments, agencies and public bodies
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
Monthly PDF editions of the Drug Safety Update newsletter from MHRA and its independent advisor, the Commission on Human Medicines
Details of the Yellow Card scheme, which is the system for recording adverse incidents with medicines and medical devices in the UK.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
This guidance summarises our approach to pharmacovigilance
Advice on writing clear notices and maximising replies to your FSNs.
How to comply with the requirements on promoting medicines to the public and to prescribers and suppliers of medicines.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
Guidance on how to submit changes to labelling and patient information leaflets to MHRA.
Information for patients, healthcare professionals and developers of new medicines
Comply with good pharmacovigilance practice and prepare for an inspection.
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
Guidance on the submission, processing and assessment of all completed paediatric studies sponsored by Marketing Authorisation Holders (MAHs)
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