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A list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
1. Overview The Windsor Framework changed the regulation of medicinal…
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Pharmacy (P), prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
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'
The process for applicants applying for a paediatric investigation plan (PIP) modification or waiver.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
A summary of the types of scientific advice available at the MHRA, the process for getting advice and the fees involved.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
How the MHRA processes variations to marketing authorisations.
There are changes to the legislation on reference medicinal products (RMPs) used to support abridged marketing authorisation applications.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
Detailed guidance on advertising and promoting medicines.
How to get a marketing authorisation (MA) for an advanced therapy medicinal product (ATMP) so it can be sold and/or supplied in the United Kingdom.
Information on comparator products used in studies supporting abridged marketing authorisation application.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
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