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How to conform with the legal requirements for placing medical devices on the market.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
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.
This document provides guidance on the data integrity expectations that should be considered by organisations involved in any aspect of the pharmaceutical lifecycle or GLP studies regulated by MHRA.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
Detailed guidance on advertising and promoting medicines.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Information on comparator products used in studies supporting abridged marketing authorisation application.
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)
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
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