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The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Guidance on clinical trials that are categorised as ‘notifiable’.
You must get permission to export certain drugs and medicines.
Information on how ICH E6(R3) good clinical practice (GCP) principles are implemented and enforced in UK clinical trial legislation.
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.
Helping manufacturers define the characteristics of their devices and determine the appropriate regulatory qualification and classification.
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 the MHRA makes decisions on whether a borderline product is a medical device and which risk class should apply.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Guidance on the deadlines for initial and response submissions.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages, making them more flammable.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
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.
Fees payable to the MHRA from 2025.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
How the MHRA decides whether to approve a clinical investigation for medical devices.
Guidance for submitting changes to labels and Patient Information Leaflets (PILs) as a self-certification.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
Advice and guidance on the management and use of point-of-care testing (POCT) in vitro diagnostic (IVD) devices.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
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