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Guidance on the collection, verification, and reporting of safety events in clinical trials of an investigational medicinal product.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Safety leaflet on topical corticosteroids and withdrawal reactions to help patients and their carers to use these medicines safely.
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
The characteristics, symptoms, diagnosis and treatment of alpha-gal syndrome.
Following the completion of a safety review and the recommendations of the Commission on Human Medicines (CHM), the IXCHIQ Chikungunya vaccine is no longer indicated for adults over the age of 60 years, and is contraindicated in all individuals with...
How to apply for a clinical trial including eligibility, phases, model IMPDs, costs and how to make changes to your application.
The Commission on Human Medicines (CHM) has temporarily restricted use of the IXCHIQ Chikungunya vaccine in people aged 65 years and over following very rare fatal reactions reported globally. This is a precautionary measure while the MHRA conducts a safety...
Guidance for people with symptoms of a respiratory infection including COVID-19, or a positive test result for COVID-19.
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