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Departments, agencies and public bodies
News stories, speeches, letters and notices
Detailed guidance, regulations and rules
Reports, analysis and official statistics
Consultations and strategy
Data, Freedom of Information releases and corporate reports
How to package medicines for sale and what information you must provide to consumers and healthcare professionals.
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.
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
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'
Information about the risks of taking valproate medicines during pregnancy.
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
Information on when software applications are considered to be a medical device and how they are regulated.
Who can supply and or administer specific medicines to patients without a doctor under a PGD and which medicines can be administered.
Guidance on the 150-day assessment timeline for high-quality marketing authorisation applications including information on how to apply.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
How to conform with the legal requirements for placing medical devices on the market.
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
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)’
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
Pharmacovigilance system requirements
How to use this new procedure for medicines licensing applications.
Apply for a promising innovative medicine (PIM) designation or scientific opinion for your medicine from MHRA.
You must get permission to export certain drugs and medicines.
Information about the EU Regulations and their implementation in Northern Ireland
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