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Information about when you need to submit substantial amendments to a clinical trial including changes to the trial sponsor or legal representative, Investigational medicinal product certification and importation.
Guidance on how to license electronic cigarettes and other inhaled nicotine-containing products (NCPs) as medicines in the UK.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Guidance for manufacturers, importers and distributors.
Check when packaging is classified as a finished plastic packaging component, and what is meant by substantial modifications, to find out if you must register for the tax.
This guidance relates to Technical Standards and Standard Development Organisations to describe the typical first step in a Standard Essential Patent (SEP) journey.
The UK and US signed a Memorandum of Understanding on critical minerals in Washington DC on 4 February.
How to apply for an exemption to use a restricted substance to manufacture electrical and electronic equipment.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
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