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Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
The Medicines and Healthcare products Regulatory Agency regulates medicines, medical devices and blood components for transfusion in the UK. MHRA is an executive agency, sponsored by the Department of Health and Social Care .
Directory of current ICH Guidelines which have been implemented by the Medicines and Healthcare products Regulatory Agency.
How to get scientific advice about your licence application from MHRA, including: submitting a request, your meeting with MHRA, fees.
A new pathway supporting innovative approaches to the safe, timely and efficient development of medicines to improve patient access.
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Comply with good manufacturing practice (GMP) and good distribution practice (GDP), and prepare for an inspection.
You must get permission to export certain drugs and medicines.
As a vet or pharmacist, you must follow legal requirements when working with controlled drugs in veterinary medicine.
Don’t include personal or financial information like your National Insurance number or credit card details.
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