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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, 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.
Information on comparator products used in studies supporting abridged marketing authorisation application.
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 for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How the MHRA processes variations to marketing authorisations.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Detailed guidance on advertising and promoting medicines.
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
Submission dates and how the submissions using the EC decision reliance procedure work.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
Initial list of individual human medicinal products under the new arrangements coming into effect on 1 January 2025 following agreement of the Windsor Framework.
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