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Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
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.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
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'
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.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How the MHRA processes variations to Marketing Authorisations (MAs)
This guidance provides information on comparator products used in studies supporting abridged marketing authorisation applications
Detailed guidance on advertising and promoting medicines.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
How to get a parallel import licence for your medicine in the UK, including pharmacovigilance requirements and submitting your application.
How to change the ownership from one marketing authorisation (MA) holder to another.
How to submit your periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER)
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
How to get a marketing authorisation for an Advanced Therapy Medicinal Product (ATMP) so it can be sold and/or supplied in Great Britain.
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