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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.
A series of webinars providing guidance on the Windsor Framework agreement and the supply of medicines in Northern Ireland.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
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.
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'
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
How the MHRA processes variations to Marketing Authorisations (MAs)
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
Detailed guidance on advertising and promoting medicines.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
How to change the ownership from one marketing authorisation (MA) holder to another.
How the MHRA assesses Marketing Authorisation Applications (MAA) for medicines referred under Article 29.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
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