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Data, Freedom of Information releases and corporate reports
Information on comparator products used in studies supporting abridged marketing authorisation application.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
How to use the procedure for medicines licensing applications.
How we engage and involve patients and the public in our regulatory decision-making.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
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.
How the MHRA processes variations to medicines' marketing authorisations for the UK and Northern Ireland.
How to conform with the legal requirements for placing medical devices on the market.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
Detailed guidance on advertising and promoting medicines.
Guidance on using non-investigational medicinal products in a clinical trial.
A practical guide to using medical devices in a range of healthcare settings.
Guidance on the process for ending a clinical trial.
Guidance on transitional arrangements for the Clinical Trials Regulations.
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.
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