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Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Fees payable to the MHRA from 2025.
Guidance on the MHRA’s national assessment procedure for marketing authorisation applications.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How the MHRA processes variations to marketing authorisations.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
How to conform with the legal requirements for placing medical devices on the market.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Detailed guidance on advertising and promoting medicines.
Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance…
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
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.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Information on comparator products used in studies supporting abridged marketing authorisation application.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
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.
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