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The Innovative Devices Access Pathway (IDAP) pilot is designed to accelerate the development of innovative medical devices that meet an unmet clinical need in the NHS and support their integration into the UK market.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
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.
Guidance on submitting an application for approval of a clinical trial that includes an in vitro diagnostic device
Guidance on using non-investigational medicinal products in a clinical trial.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
How the MHRA makes decisions on what is a medicinal product (borderline products).
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
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)’
Information on comparator products used in studies supporting abridged marketing authorisation application.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
Detailed guidance on advertising and promoting medicines.
Fees payable to the MHRA from 2025.
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.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
How to write clear and effective field safety notices (FSNs) for medical devices.
Don’t include personal or financial information like your National Insurance number or credit card details.
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