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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.
How to apply for, update and cancel licences for the manufacture, import and wholesale of human and veterinary medicines.
Information about the risks of taking valproate medicines during pregnancy.
UK companies who have their licence to manufacture or wholesale medicines terminated and cancelled.
Information for manufacturers, healthcare professionals, researchers and patients on software as a medical device (SaMD) and AI as a medical device (AIaMD).
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
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'
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 about the EU Regulations and their implementation in Northern Ireland
UK approved bodies listed under Medical Devices Regulations 2002 (SI 2002 No 618, as amended) (UK MDR 2002).
Information on when software applications are considered to be a medical device and how they are regulated.
How to use this new procedure for medicines licensing applications.
Safety leaflet to help you understand the latest information about the effects of pregabalin during pregnancy.
The Medicines and Healthcare Regulatory Agency have launched RegulatoryConnect, a service that provides the capability to track applications and view live authorisation details.
You must get permission to export certain drugs and medicines.
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)’
How to apply for a traditional herbal registration (THR) to market a herbal medicine in the UK.
Pharmacovigilance system requirements
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