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Detailed guidance, regulations and rules
Reports, analysis and official statistics
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Data, Freedom of Information releases and corporate reports
Fees payable to the MHRA from 2025.
Guidance for health institutions that manufacture general medical devices under the Health Institution Exemption (HIE).
Information to help comply with ICH E6(R3), if you are running clinical trials in the UK.
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
Guidance on the deadlines for initial and response submissions.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
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.
Detailed guidance on advertising and promoting medicines.
A wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
How the MHRA makes decisions on what is a medicinal product (borderline products).
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
Guidance on the process for ending a clinical trial.
Guidance on clinical trials that are categorised as ‘notifiable’.
How to use the procedure for medicines licensing applications.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
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