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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 for hospital blood banks on issuing blood components electronically in line with best practice.
Update on MHRA UK risk-based GxP inspection programme.
Guidance for industry on preparing responses to good laboratory practice (GLP) and good clinical practice (GCP) inspection reports.
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Outlines the aim, scope and definitions of the medical technology innovation classification framework.
How and when to register updated packaging and information leaflets when new national marketing authorisations have been issued
Dear colleague letter from Barry Cockcroft, Chief Dental Officer, dated 24 March 2011. Download :National Institute for Health and Clinical…
Actions that trial sponsors should consider to build resilience into clinical trial design
How to apply to have nutritional or dermatological products reviewed by the Advisory Committee on Borderline Substances (ACBS).
A summary of actions related to problems with T34 syringe drivers
There is an obligation on the manufacturers and importers of electronic cigarettes to submit a notification of such products they intend to market.
Sets out the payment due from members of the voluntary scheme for branded medicines pricing and access in 2023.
Access Consortium Statement on Good Manufacturing Practice (GMP) Inspections Reliance and Recognition
Information for local authorities in England about the grant, which will support local authorities to deliver routine commissioning of PrEP in 2020 to 2021.
Our Patient Involvement Strategy sets out how we will engage and involve the public and patients at every step of the regulatory journey.
What is considered off-label use of a medical device and examples of it.
Guidance for industry on flexible approaches we are taking on good distribution practices.
The EU has published guidance on exemptions for medical devices manufactured and used within EU health institutions, which applies to Northern Ireland-based health institutions, replacing interim guidance from the MHRA.
Dose of nicotine delivered & uptake and consistency of dose.
Guidance for manufacturers who don’t design or manufacture devices but place their names on the product.
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