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This is a work sharing model for the co-ordinated assessment of a generic application that has been filed with multiple Access Consortium agencies.
How the ‘Written Confirmation’ process operates for active substances manufactured in Great Britain (England, Wales and Scotland).
Notification Fees for Great Britain and Northern Ireland
The types of emissions a manufacturer or importer of e-cigarettes should notify us about.
Acceptable naming, presentation and packaging of nicotine-containing electronic cigarettes and refill containers.
Submitting annual reports on sales of electronic cigarettes and refill containers.
Due diligence for suppliers of e-cigarettes and e-liquids.
Top tips for healthcare professionals on safely managing electrosurgery from the Medicines and Healthcare products Regulatory Agency (MHRA).
Guidance for Marketing Authorisation (MA) applicants on providing consent to share operational information during the MA application process.
Top 10 tips on how to measure blood pressure.
The MHRA is ready to provide any assistance for clinical trials applications submitted for COVID-19
Antipsychotic drugs available in the UK, their side effects and their effect on dementia patients.
These temporary good manufacturing practice (GMP) flexibilities will be allowed to address the current exceptional circumstances
Expansion of extra-jurisdictional inspection outcomes.
The Medicines and Healthcare products Regulatory Agency (MHRA) offer a pre-submission service before applying for medicines Marketing Authorisations.
A set of principles for understanding the impact of new variants on antiviral drugs and monoclonal antibodies
For manufacturers reporting adverse incidents with joint replacement implants under the vigilance system.
Outcomes from the first meeting with the regulators of medicine who had met globally to discuss dementia.
The MHRA position on the appropriate classification of point-of-use water filters for the UK market, and advice for suppliers and procurers of these products
When tests to detect COVID-19 are commonly used (use cases) and what to consider when deciding which type of test to employ.
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