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Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
Guidance on using non-investigational medicinal products in a clinical trial.
Information on comparator products used in studies supporting abridged marketing authorisation application.
How the MHRA processes variations to marketing authorisations.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
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.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
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.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Detailed guidance on advertising and promoting medicines.
Fees payable to the MHRA from 2025.
What you need to do before your product can be placed on the Great Britain market with a UKCA mark.
Guidance on transitional arrangements for the Clinical Trials Regulations
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