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This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
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.
Cancel a marketing authorisation, traditional herbal registration or parallel import product licence or withdraw a pending submission.
How to join the phase I accreditation scheme.
The Vaccine Development Evaluation Centre (VDEC) at Porton Down in Wiltshire facilitates the development and evaluation of new vaccines and therapeutics.
A digital platform designed to facilitate the reporting, monitoring, and management of medical device incidents.
Information about the MHRA's duties and how you can report a non-compliant medical device.
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 summarises our approach to pharmacovigilance
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Guidance on out of specification investigations, including definitions and laboratory analysis and phase I,II and III investigations.
Guidance on the process for ending a clinical trial.
Guidance on clinical trials that are categorised as ‘notifiable’.
Comply with good pharmacovigilance practice and prepare for an inspection.
A letter to community pharmacy contractors to set out the detail of the agreed funding arrangements for community pharmacy.
An initiative to help drive advancements in healthcare, to ensure patients benefit from innovation and new treatments sooner.
How to comply with the regulatory requirements for manufacturing custom-made medical devices.
Guidance on the safe and effective use of GLP-1 medicines for weight loss and diabetes.
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.
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