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How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Information on clinical trial record retention and archiving requirements including requirements for ownership, data integrity, and transitional provisions.
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.
Information on the new regulations for the post-market surveillance of medical devices which come into effect on 16 June 2025.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
How the MHRA makes decisions on what is a medicinal product (borderline products).
You must get permission to export certain drugs and medicines.
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
Information to help comply with ICH E6(R3), if you are running clinical trials in the UK.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
Guidance on the deadlines for initial and response submissions.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
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.
How the MHRA processes variations to marketing authorisations.
Information on comparator products used in studies supporting abridged marketing authorisation application.
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.
Keep up to date with the latest information from the UK GLP monitoring authority.
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