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Guidance for Marketing Authorisation Holders and holders of other types of authorisations on their responsibilities for veterinary pharmacovigilance and how to report suspected Adverse Events.
Advises on how planning can manage potential noise impacts in new development.
Information for public health professionals on immunisation.
Guidance on managing and using bed rails safely.
Explainer for the pharmaceutical industry on Pharmacovigilance requirements mitigations to bridge the gap between the implementation of the EU Regulation on veterinary medicines and the revised Veterinary Medicines Regulations as they have an effect in Great Britain (GB VMR).
Information relating to rare side effects after vaccination.
Healthcare professionals prescribing montelukast should be alert to the risk of neuropsychiatric reactions in all patients including children and adolescents. Reported neuropsychiatric reactions include sleep disorders, hallucinations, anxiety and depression, as well as changes in behaviour and mood. Healthcare professionals...
Information for manufacturers of medical devices about reporting adverse incidents and field safety corrective actions to the MHRA.
Urgent safety updates arising from pharmacovigilance data, including reported adverse events, for veterinary medicines authorised in the UK.
A patient alert card is being introduced for men taking finasteride to help raise awareness of the risk of psychiatric side effects and sexual dysfunction, including the potential for sexual dysfunction to persist after treatment has stopped. Healthcare professionals are...
How marketing authorisation holders should inform MHRA of a signal or an ADR to a medicine.
Change your protocol, update your authorisation, report safety issues, submit safety updates and complete your end-of-trial study report.
Organisational definitions of terms concerned with risk and risk-related matters.
Guidance relating to blood clotting, myocarditis and Guillain-Barré Syndrome (GBS) after COVID-19 vaccination.
How investigators and sponsors should manage clinical trials during COVID-19
Report a problem ('adverse incident') with a medical device or medicine to MHRA using the Yellow Card Scheme
The review of the safety of isotretinoin has concluded.
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