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Greinasafn
December 17, 2021
08. What is the meaning of the red warning triangle?
December 17, 2021
07. How long is there an obligation to create and submit PSURs or RMPs after a marketing authorisation was withdrawn?
December 17, 2021
06. How long is there an obligation to continue collection and submission of spontaneous ADR reports after a marketing authorisation of the suspect product was withdrawn?
December 17, 2021
05. Are Marketing Authorisation Holders required to have a Local Contact Person for Pharmacovigilance in Iceland?
December 17, 2021
04. Are Marketing Authorisation Holders required to have a Qualified Person for PharmacoVigilance (QPPV) residing in Iceland?
December 17, 2021
03. Does IMA require literature reports for Icelandic cases? Should a copy of the literature article be attached?
December 17, 2021
02. Is there a list of local literature that the Marketing Authorisation Holders should monitor?
December 17, 2021
01. What happens to ICSRs received by IMA from healthcare professionals and the public?