Electronic transmission of individual case safety reportshttps://legemiddelverket.no/english/pharmacovigilance/electronic-transmission-of-individual-case-safety-reportsElectronic transmission of individual case safety reports As of November 2005 the Norwegian Medicines Agency (NOMA) only accepts individual case safety reports (ICSRs) electronically through Eudravigilance gateway. 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
Information regarding the transfer to a new national pharmacovigilance databasehttps://legemiddelverket.no/nyheter/information-regarding-the-transfer-to-a-new-national-pharmacovigilance-databaseInformation regarding the transfer to a new national pharmacovigilance databaseNoMA is in the process of acquiring a new pharmacovigilance database. According to the current plan, NoMA will transfer from the old database to the new system by the end of October 2017. 1354
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 introduction of the new pharmacovigilance legislationhttps://legemiddelverket.no/english/pharmacovigilance/questions-and-answers-about-the-introduction-of-the-new-pharmacovigilance-legislationQuestions and answers about the introduction of the new 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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