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Greinasafn

08. What is the meaning of the red warning triangle?

07. How long is there an obligation to create and submit PSURs or RMPs after a marketing authorisation was withdrawn?

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collection and submission of spontaneous ADR reports after a marketing authorisation of the suspect product was withdrawn?

05. Are Marketing Authorisation Holders required to have a Local Contact Person for Pharmacovigilance in Iceland?

04. Are Marketing Authorisation Holders required to have a Qualified Person for PharmacoVigilance (QPPV) residing in Iceland?

03. Does IMA require literature reports for Icelandic cases? Should a copy of the literature article be attached?

02. Is there a list of local literature that the Marketing Authorisation Holders should monitor?

01. What happens to ICSRs received by IMA from healthcare professionals and the public?

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