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A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
You must get permission to export certain drugs and medicines.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Search for information about medicines including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Information for companies on the import and export of controlled drugs to and from the UK.
An overview of the process including submitting or fast-tracking an application, naming your medicine and paying fees.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
Licence and registration application information for companies that deal in precursor chemicals.
Pharmacy, prescription-only (POM), and general sale list (GSL) medicines: apply to move your medicine to a different classification.
How the MHRA makes decisions on when a product is a medical device (borderline products), and which risk class should apply to a medical device.
Register as a manufacturer, importer or distributor of active substances.
How to contact MHRA for specific services or enquiries.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
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.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
Guidance for prescribing vets on the use of the cascade.
How the MHRA makes decisions on what is a medicinal product (borderline products).
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