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The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
How to conform with the legal requirements for placing medical devices on the market.
Information on the alignment of the amended UK clinical trial legislation with the Declaration of Helsinki, prioritising UK law where conflicts arise.
Guidance on clinical trials that are categorised as ‘notifiable’.
Guidance on manufacturing, importing, distributing and supplying specially manufactured or ordered products, including cannabis-based products for medicinal use in humans (CBPMs), known as 'specials'
Guidance on good manufacturing practice and the use of radiopharmaceutical investigational medicinal products in clinical trials.
Detailed guidance on advertising and promoting medicines.
Who can supply or administer medicines to patients without a doctor under a PGD, which medicines they can supply, and legal requirements for PGDs.
Information about how the MHRA regulates medical devices in Northern Ireland and what legislation applies to manufacturers and suppliers.
Patient factsheet providing information on respiratory syncytial virus (RSV) and RSV vaccination.
By streamlining decision-making, the MHRA–NICE aligned pathway will help patients access new medicines 3–6 months sooner.
Information on when software applications (apps) are considered to be a medical device and how they are regulated.
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.
Approach to MHRA’s assessment of applications for medicines that use alternative methods to replace animals in science
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Reporting, investigating and recalling suspected defective medicinal products to the Defective Medicines Report Centre (DMRC).
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.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
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.
Do not include personal or financial information like your National Insurance number or credit card details.
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