Electronic transmission of individual case safety reports by the Marketing authorisation holderhttps://legemiddelverket.no/english/pharmacovigilance/electronic-transmission-of-individual-case-safety-reportsElectronic transmission of individual case safety reports by the Marketing authorisation holder As of November 2017 the Marketing authorisation holder shall report individual case safety reports (ICSRs) directly to EudraVigilance (EV).438
Frequently asked questions (FAQ) – Electronic transmission of individual case safety reportshttps://legemiddelverket.no/english/pharmacovigilance/frequently-asked-questions-faq-electronic-transmission-of-individual-case-safety-reportsFrequently asked questions (FAQ) – Electronic transmission of individual case safety reportsThis information is meant as guidance on specific topics, and reflects frequently asked questions from the marketing authorisation holders (MAHs). 439
Guidance for submission of Norwegian translations of direct healthcare professional communication (DHPC)https://legemiddelverket.no/english/pharmacovigilance/guidance-for-submission-of-norwegian-translations-of-direct-healthcare-professional-communication-dhpcGuidance for submission of Norwegian translations of direct healthcare professional communication (DHPC)Direct healthcare professional communication (DHPC) is communication regarding important safety information delivered directly to individual healthcare professionals by a marketing authorisation holder.1958
Procedure for follow-up information requests for adverse reaction reportshttps://legemiddelverket.no/english/pharmacovigilance/procedure-for-follow-up-information-requests-for-adverse-reaction-reportsProcedure for follow-up information requests for adverse reaction reportsThe routine request for follow-up information by the marketing authorisation holder (MAH) to an adverse reaction report/ICSR received from NOMA should be limited.1551The routine request for follow-up information by the marketing authorisation holder (MAH) to an adverse reaction report/ICSR received from NOMA should be limited.
Procedure for notifying emerging safety issueshttps://legemiddelverket.no/english/pharmacovigilance/procedure-for-notifying-emerging-safety-issuesProcedure for notifying emerging safety issuesNotification of an emerging safety issue (ESI) should be sent by e-mail to the Norwegian Medicines Agency within three working days after establishing an ESI. The subject line of the e-mail should include the words “emerging safety issue” or “ESI”. 1554
Questions and answers about the pharmacovigilance legislationhttps://legemiddelverket.no/english/pharmacovigilance/questions-and-answers-about-the-introduction-of-the-new-pharmacovigilance-legislationQuestions and answers about the pharmacovigilance legislation440
What is pharmacovigilancehttps://legemiddelverket.no/english/pharmacovigilance/what-is-pharmacovigilanceWhat is pharmacovigilancePharmacovigilance is an important tool for ensuring safe and effective drugs. The purpose is to gather information about safety in clinical use and shorten the time until the safety profile of a drug is well known.437

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