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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
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.
Resources for World Antimicrobial Resistance Awareness Week (WAAW) and European Antibiotic Awareness Day (EAAD) for healthcare professionals in England.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Guidance on transitional arrangements for the Clinical Trials Regulations
You must get permission to export certain drugs and medicines.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Detailed guidance on advertising and promoting medicines.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Guidance on the deadlines for initial and response submissions.
Fees payable to the MHRA from 2025.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
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