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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
Guidance on what approved bodies are, what they do and how you can become one.
A document for patients explaining how the highest risk patient groups eligible for new coronavirus treatments will be identified.
Guidance on defining intended purpose for Software as a Medical Device (SaMD), to help SaMD manufacturers in meeting their statutory obligations.
This guidance covers ‘grandfathering’ and managing the lifecycle changes of medicinal products.
A 5-year deal setting out how community pharmacy will support delivery of the NHS Long Term Plan.
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
Safety leaflet on epilepsy medicines and pregnancy to help patients and their families understanding the risks.
Information about how to register your homeopathic medicinal product through the Simplified Homeopathic Registration Scheme or the UK Homeopathic National Rules Scheme
This toolkit is for Innovation Passport holders following the Innovative Licensing and Access Pathway (ILAP) and provides activities to support the design and development of medicines.
The approach the MHRA intends to take for products approved or pending in decentralised procedure (DCP) or mutual recognition procedures (MRP).
The MHRA will review applications for orphan designation at the time of a marketing authorisation (MA) or variation application.
An interpretation of the good manufacturing practice (GMP) requirements for specials manufacturers.
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
Guidance on Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
How to distinguish between products that are regulated as medical devices and those regulated as medicinal products.
Industry must notify the MHRA if they will not be using these flexibilities
Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products
How to use RamaXL, including system availability, running reports and how to subscribe.
There are different regulations which apply to devices and equipment including hand gels and PPE (personal protective equipment)
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