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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.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
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'
Apply now to join the AI Airlock pilot by the MHRA. Benefit from industry and regulatory expert collaboration, bespoke testing plans, and improved regulatory understanding.
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Details of how Marketing Authorisation Holders can provide information on planned or potential future submissions, to the MHRA.
How the MHRA processes variations to Marketing Authorisations (MAs)
The Early Access to Medicines Scheme (EAMS) aims to give patients with life threatening or seriously debilitating conditions early access to medicines that show early signs of having a major advantage over existing therapeut…
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
There are changes to the legislation of Reference Medicinal Products (RMPs) used to support abridged marketing authorisation applications
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