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How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
Guidance on conditional marketing authorisations, exceptional circumstances marketing authorisations and national scientific advice.
How to show the MHRA you're meeting good clinical practice (GCP) standards and what to expect from an inspection.
Guidance for the veterinary pharmaceutical industry on the production and submission of the Summary of Product Characteristics (SPCs) and product literature mock-ups.
You must include the appropriate legal basis for your application when you apply to MHRA for a marketing authorisation.
These reports explain our assessment of the scientific evidence used to lead to regulatory decisions on the safety of medicines or medicines classes.
How a marketing authorisation holder should report a defect with a veterinary medicine.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
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