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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
Points to consider when using real-world data in clinical studies
Information on the implementation of changes to the licensing of medicines for human use in the UK following the agreement of the Windsor Framework.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
An overview of the legal requirements for children’s medicines that Marketing Authorisation Holders (MAHs) need to abide by.
A step-by-step guide on using the MORE Platform for Registrations for Submissions of device related incidents.
Guidance for marketing authorisation holders on drafting direct healthcare professional communications (DHPCs)
Guidance covering various aspects of pharmacovigilance for authorised and unauthorised medicinal products (Specials and the Early Access to Medicines Scheme (EAMS)).
Anyone in Northern Ireland selling medicines to the public via a website must still comply with the requirement to apply the EU common logo.
What you need to do to supply authorised medicines from Great Britain to Northern Ireland.
Webinars for pharmaceutical companies, clinical trial sponsors, e-cigarette producers and brokers of medicinal products
Information and advice on submitting a nutritional product to the Advisory Committee for Borderline Substances (ACBS).
Approved countries for batch testing and importation of medicines
Actions QPs, RPis and RPs need to take following agreement of the Windsor Framework
Information about how approved bodies help regulate medical devices and how to apply for approval.
How the MHRA makes decisions on whether a borderline product is a medical device or a medicinal product.
Documentation to support changes made to reporting Manufacturer Incident Reports (MIRs) and Field Safety Corrective Action Reports (FSCAs) to the MHRA following implementation of the Medical Devices (Post-market Surveillance…
Overview of the different types of MHRA safety communications about medicines, medical devices and other healthcare products, including what they are and who they are aimed at, and information on decision-making around safet…
How investigators and sponsors should manage clinical trials during COVID-19
How we engage and involve patients and the public in our regulatory decision-making.
Guidelines to provide developers of biosimilar products with a clear outline of the requirements in Great Britain.
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