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Guidance for Applicants wishing to apply for a Promising Innovative Medicines designation, pre-submission meeting or an EAMS Scientific Opinion.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
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.
Guidance on the Ionising Radiation (Medical Exposure) Regulations 2017 for employers and health professionals who carry out medical radiological procedures.
Information on the implementation of changes to pharmacovigilance for medicines authorised in the UK following the agreement of the Windsor Framework.
How to contact MHRA for specific services or enquiries.
Details of the process changes for established medicines, effective from 1 March 2024, which apply specifically to chemical products.
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'
Guidance for pharmacists on prescriptions issued in EU countries, Norway, Iceland, Liechtenstein and Switzerland.
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
How to conform with the legal requirements for placing medical devices on the market.
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 wholesale dealer in Great Britain may import Qualified Person certified medicines from the European Economic Area if certain checks are made by the ‘Responsible Person (import)’
Guidance for UK wholesalers and manufacturers on how to import human medicines including unlicensed medicines, how to apply for a licence and how much it costs.
You must get permission to export certain drugs and medicines.
Pharmacovigilance system requirements
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
Information on when software applications are considered to be a medical device and how they are regulated.
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