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Guidance on submitting clinical trial safety reports

Guidance on submitting clinical trial safety reports
How to submit Suspected Unexpected Serious Adverse Drug Reactions (SUSARs) and annual safety reports Development Safety Update Reports (DSURs).
From:
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You must submit SUSARs in Great Britain and in Northern Ireland to the MHRA in one of the following ways:
If you intend to submit SUSARs using one of the new reporting routes, you must register.
For trials ongoing in both the UK and in European member states dual reporting is needed. You will need to report each SUSAR to both the MHRA and relevant member states, as well as to the European Medicines Agency’s (EMA’s) Eudravigilance Clinical Trial Module (EVCTM). ....

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Regulating medical devices in the UK

Regulating medical devices in the UK
What you need to do to place a medical device on the Great Britain, Northern Ireland and European Union (EU) markets.
From:
MHRA) is responsible for regulating the UK medical devices market.
This guidance provides information on the UK system, including for:
getting your device certified
MHRA
This guidance is divided into sections on the different rules that apply in Great Britain, Northern Ireland and the EU. Great Britain is England, Wales and Scotland.
For Northern Ireland, different rules apply to those in Great Britain. For more information on the regulatory system for medical devices in Northern Ireland, please see Regulation of medical devices in Northern Ireland below. ....

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Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021

Exporting active substances manufactured in Great Britain for use in EEA and Northern Ireland from 1 January 2021
gov.uk - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from gov.uk Daily Mail and Mail on Sunday newspapers.

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