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The MHRA’s AI Airlock second phase ran between April 2025 and May 2026. This report does not constitute formal MHRA guidance.
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)’
Guidance on the deadlines for initial and response submissions.
Information about the MHRA graduate scheme which is currently closed for applications.
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.
Keep up to date with the latest information from the UK GLP monitoring authority.
Guidance on transitional arrangements for the Clinical Trials Regulations.
Detailed guidance on advertising and promoting medicines.
The pilot aims to deliver the first wave 1 regulatory assessment in 14 calendar days for qualifying applications by the end of 2026.
Guidance on clinical trials that are categorised as ‘notifiable’.
Guidance on the process for ending a clinical trial.
The eMIT provides information about prices and usage for generic drugs and pharmaceutical products.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
How to apply for a regulatory advice meeting on medical devices and in vitro diagnostic devices.
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.
How to join the phase I accreditation scheme.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Details of the organisations that are currently approved to undertake conformity assessments on medical devices.
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