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Information on MHRA's enforcement duties and how to report a non-compliant medical device.
How to contact MHRA for specific services or enquiries.
The MHRA have published a roadmap which outlines the intended timelines for delivering the future regulatory framework for medical devices.
Safety leaflet on opioid medicines to help patients and their families reduce the risks of harm.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Submissions related to human medicines need to be submitted directly to the MHRA.
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'
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Pharmacovigilance system requirements
How to conform with the legal requirements for placing medical devices on the market.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
Information on when software applications are considered to be a medical device and how they are regulated.
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)’
You must get permission to export certain drugs and medicines.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
How to use this new procedure for medicines licensing applications.
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.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
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