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Information on when software applications (apps) are considered to be a medical device and how they are regulated.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
The review of the safety of isotretinoin has concluded.
Guidance on clinical trials that are categorised as ‘notifiable’.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
How to interpret post-market surveillance (PMS) requirements for medical devices in Great Britain.
Take care when using creams to treat dry skin conditions as they can easily dry onto clothing, bedding and bandages making them more flammable.
Guide for marketing authorisation holders, including qualified person responsible for pharmacovigilance (PV) and pharmacovigilance system master files (PSMF).
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
Comply with good pharmacovigilance practice and prepare for an inspection.
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Transitional arrangements and timelines for acceptance of CE marked medical device in Great Britain.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
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.
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.
How to use the procedure for medicines licensing applications.
This guidance clarifies the expectations on the application of the EU guidance on good pharmacovigilance practices (GVP)
The Innovative Licensing and Access Pathway (ILAP) is focused on getting the most transformative new medicines to patients in the UK health system more quickly.
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