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A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Submissions related to human medicines need to be submitted directly to the MHRA.
How to contact MHRA for specific services or enquiries.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Information about controlled drugs licences for companies that possess, manufacture, produce or supply controlled drugs in England, Wales or Scotland.
Eligible health and social care providers can order PPE through the portal to meet the increased need that has arisen as a result of the COVID-19 pandemic.
You must get permission to export certain drugs and medicines.
Information for prospective growers of low THC cannabis (industrial hemp), for the production of seed and fibre only.
An overview of the process including submitting or fast tracking an application, naming your medicine and paying fees.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Information for companies on the import and export of controlled drugs to and from the UK.
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to register on the MHRA portal and use it to apply for and update marketing authorisations and make other applications.
Guidelines to help mitigate and manage medicine shortages.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
The process for applicants applying for a Paediatric Investigation Plan (PIP) modification or waiver.
Register as a manufacturer, importer or distributor of active substances.
The MHRA is continuing to accept Active Substance Master Files (ASMFs) and Certificates of Suitability (CEPs)
Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products
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