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The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Information about medical devices that the public can buy for personal use and how we make sure they are safe and effective.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Guidance on the deadlines for initial and response submissions.
How the MHRA makes decisions on what is a medicinal product (borderline products).
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)’
You must get permission to export certain drugs and medicines.
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.
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.
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.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
How we regulate in vitro diagnostic medical devices (IVDs) that are placed on the UK market.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How the MHRA processes variations to marketing authorisations.
How the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
Information on comparator products used in studies supporting abridged marketing authorisation application.
How to use the procedure for medicines licensing applications.
Keep up to date with the latest information from the UK GLP monitoring authority.
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