| Reported suspected adverse reactions of covid-19 vaccines | https://legemiddelverket.no/english/covid-19-and-medicines/vaccines-against-covid-19/reported-suspected-adverse-reactions-of-covid-19-vaccines | Reported suspected adverse reactions of covid-19 vaccines | The Norwegian Medicines Agency publishes overviews of suspected adverse reactions associated with corona vaccination in Norway. From week 13 (2022) reports will only be published in Norwegian. | 2840 | |
| Educational material - guidance for submission and distribution | https://legemiddelverket.no/english/pharmacovigilance/educational-material-guidance-for-submission-and-distribution | Educational material - guidance for submission and distribution | Marketing authorisation holders may be required to make material for the training of healthcare professionals, patients and relatives for medicines which have a special risk of adverse drug reactions. The purpose of the material is to reduce these risks. | 2746 | |
| Frequently asked questions (FAQ) – Electronic transmission of individual case safety reports (ICSRs) | https://legemiddelverket.no/english/pharmacovigilance/frequently-asked-questions-faq-electronic-transmission-of-individual-case-safety-reports | Frequently asked questions (FAQ) – Electronic transmission of individual case safety reports (ICSRs) | This 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-dhpc | Guidance 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 | |
| How do I report suspected adverse reactions after taking medicines or vaccines? | https://legemiddelverket.no/english/pharmacovigilance/how-do-i-report-suspected-adverse-reactions-after-taking-medicines-or-vaccines | How do I report suspected adverse reactions after taking medicines or vaccines? | You can report suspected adverse reactions using an electronic reporting form at helsenorge.no. This form requires you to log in using an electronic ID. This prevents unauthorised persons from accessing your information. | 3347 | |
| No national requirements to the pharmacovigilance legislation | https://legemiddelverket.no/english/pharmacovigilance/no-national-requirements-to-the-pharmacovigilance-legislation | No national requirements to the pharmacovigilance legislation | | 3888 | |
| What is pharmacovigilance | https://legemiddelverket.no/english/pharmacovigilance/what-is-pharmacovigilance | What is pharmacovigilance | Pharmacovigilance 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 | |
| Procedure for follow-up information requests for adverse reaction reports | https://legemiddelverket.no/english/pharmacovigilance/procedure-for-follow-up-information-requests-for-adverse-reaction-reports | Procedure for follow-up information requests for adverse reaction reports | The routine request for follow-up information by the marketing authorisation holder (MAH) to an adverse reaction report/ICSR received from NOMA should be limited. | 1551 | The 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 issues | https://legemiddelverket.no/english/pharmacovigilance/procedure-for-notifying-emerging-safety-issues | Procedure for notifying emerging safety issues | Notification 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 | |
| The Norwegian Adverse Drug Reaction Registry | https://legemiddelverket.no/english/pharmacovigilance/the-norwegian-adverse-drug-reaction-registry | The Norwegian Adverse Drug Reaction Registry | The Norwegian Adverse Drug Reaction Registry (the NorADR registry) contains reports of suspected adverse reactions to medicines submitted by health professionals and patients and their next of kin in Norway. | 3348 | |
