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The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
How to change the ownership from one marketing authorisation (MA) holder to another.
Provides a standard framework for NHS procurement professionals to assess non-financial value when buying medical technology.
How manufacturers in Northern Ireland should undertake a clinical investigation for medical devices to ensure they comply with EU medical device regulations.
Patient factsheet providing information on respiratory syncytial virus (RSV) and RSV vaccination.
Approach to MHRA’s assessment of applications for medicines that use alternative methods to replace animals in science
The MHRA accepts an Active Substance Master File and/or a Certificate of Suitability in both new national initial Marketing Authorisation Applications (MAA) and in Marketing Authorisation Variation (MAV) applications.
Sets out medicines that can be moved to Northern Ireland to meet patient need.
Marketing Authorisation Holders should review their manufacturing processes to mitigate the risk of nitrosamine impurities being present.
Information for healthcare professionals on how pulse oximeters are regulated, home use and issues to look out for when using the devices
Information on sourcing medicines that can be supplied by wholesale distributor authorisation (WDA) holders based in the UK.
Information on applying for New Active Substance Work Sharing Initiative (NASWSI) and Biosimilar Work Sharing Initiative (BSWSI) assessments and list of approved products.
Information about ensuring blood and blood component safety.
Guidelines to help mitigate and manage medicine shortages.
Information and recommendations for manufacturers on the preparation and presentation of a periodic safety update report (PSUR).
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
A letter to community pharmacy contractors to set out the detail of the agreed funding arrangements for community pharmacy.
Which professions can act as an investigator, training and experience expectations, provision of medical support and delegation of activities.
Also covering requests for waivers or deferrals and concerning the operation of the compliance check.
The MHRA is part of the Access Consortium along with the Therapeutic Goods Administration, Health Canada, Health Sciences Authority of Singapore and Swissmedic.
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