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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.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
How to notify the MHRA of your intention to carry out a clinical investigation for medical devices.
Blogs where government organisations talk about their work and share information and ideas.
How to conform with the legal requirements for placing medical devices on the market.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
How to register your medical devices with the Medicines and Healthcare products Regulatory Agency (MHRA) for the markets in Great Britain and Northern Ireland
Advice on writing clear notices and maximising replies to your FSNs.
Guidance on Animal Test Certificates (ATCs) required to carry out the field trial of a veterinary medicine in animals (clinical trial) in the UK.
List of Field Safety Notices from 22 to 26 April 2024.
What you need to know before you can place a medical device on the Great Britain market with a UKCA mark.
Apply for a higher education course, track your application and accept or reject your offers.
Find registered patents, patent applications and pending patents
Apply for changes to your marketing authorisation, including minor variations type IA and IB, major variations type II and extensions.
Apply for an Academic Technology Approval Scheme (ATAS) certificate, to study certain subjects in the UK.
Get help to classify pharmaceutical products used to treat or prevent diseases or ailments (in humans or animals), including comparators used in clinical trials and placebos.
Find out if you need an Academic Technology Approval Scheme (ATAS) certificate to study in the UK.
Covering thalidomide, lenalidomide, and pomalidomide: temporary guidance for pregnancy prevention arrangements for patients taking them during COVID-19
Information about the EU Regulations and their implementation in Northern Ireland
Pharmacovigilance system requirements
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