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Change to the information provided on adverse events in the Summary of Product Characteristics (SPC).
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.
Project Orbis is a programme to review and approve promising cancer drugs helping patients access treatments faster.
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.
Information for patients, healthcare professionals and developers of new medicines
Guidance on transitional arrangements for the Clinical Trials Regulations.
How to get information including patient information leaflets (PILs), details on how the medicine can be used (SmPCs) and scientific reports (PARs).
Guidance on using non-investigational medicinal products in a clinical trial.
Get help to classify cigarettes, cigars, raw tobacco, smoking tobacco, tobacco for heating and nicotine substitutes for import and export.
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