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How to make a payment by credit or debit card or a bank transfer for all applications except Device Registration and Certificates of Free Sale applications.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Fees payable to the MHRA from 2025.
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.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Information on comparator products used in studies supporting abridged marketing authorisation application.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
An overview of the systems and processes DHSC and NHS England use for responding to medicine shortages.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
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.
Patient factsheet providing information on respiratory syncytial virus (RSV) and RSV vaccination.
Guidance on the deadlines for initial and response submissions.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Detailed guidance on advertising and promoting medicines.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
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)’
The MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
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