SwissMedic – Enhanced Pharmacovigilance FAQ
Enhanced Pharmacovigilance FAQ
Meeting highlights from the Pharmacovigilance Risk Assessment Committee (PRAC) 11-14 January 2021
https://www.ema.europa.eu/en/news/meeting-highlights-pharmacovigilance-risk-assessment-committee-prac-11-14-january-2021
EMA – Questions & answers on signal management
https://www.ema.europa.eu/en/documents/other/questions-answers-signal-management_en.pdf
PRAC recommendations on signals
https://www.ema.europa.eu/en/documents/prac-recommendation/prac-recommendations-signals-adopted-23-26-november-2020-prac-meeting_en.pdf
MHRA – Periodic Safety Update Reports (PSURs) for medicinal products
https://www.gov.uk/guidance/periodic-benefit-risk-evaluation-reports-for-medicinal-products#history
MHRA – Send and receive information on adverse drug reactions (ADRs)
https://www.gov.uk/guidance/send-and-receive-information-on-adverse-drug-reactions-adrs
CMDh Q&A – Pharmacovigilance Legislation
https://www.hma.eu/fileadmin/dateien/Human_Medicines/CMD_h_/Questions_Answers/CMDh_257_2012_Rev23_2020_12_clean_QA_on_PhV.pdf
Guidance on MAH and QPPV location from 1 January 2021
https://www.gov.uk/guidance/guidance-on-mah-and-qppv-location-from-1-january-2021
New reporting routes for adverse drug reaction reports by healthcare professionals from 1 January 2021
https://www.swissmedic.ch/swissmedic/en/home/news/mitteilungen/neue_meldewege_nebenwirkungsmeldungen.html