Procedure for notifying emerging safety issues
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Changes
Notification of an emerging safety issue (ESI) should be sent by e-mail to the Norwegian Medical Products 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”.
Emerging safety issue (ESI) is defined in Good Pharmacovigilance Practice (GVP) Module IX – Signal management, chapter IX.A.1.1. General Terminology and further discussed in chapter IX.C.2 emerging safety issues.
When marketing authorisation holders with medicinal products authorised in Norway become aware of an ESI they should notify the Norwegian Medical Products Agency (NoMA), the European Medicines Agency (EMA) as well as other competent authorities of Member States where the medicinal product is authorised. This should be done as soon as possible and no later than three working days after establishing that a validated signal or a safety issue is an ESI.
When notifying an ESI, the safety issue should be described, including the sources of information and any planned or taken actions, with timelines. All documentation and information relevant to the issue, available at the time of initial notification should be provided and updates should be provided as soon as more information becomes available.
Notifications should be sent to NoMA, to the mailbox: adr@noma.no. To make sure these e-mails are quickly and efficiently directed to relevant persons at NoMA, the subject line of the e-mail should include the words “emerging safety issue” and/or “ESI”.
Notifications should also be sent to EMA, to the mailbox: P-PV-emerging-safety-issue@ema.europa.eu. If planned actions include temporary or permanent cessation, suspension or withdrawal of the product from the market, the notification of such action should be sent in parallel to the mailbox: withdrawnproducts@ema.europa.eu
and to the competent authority concerned
Emerging safety issues regarding quality defects should be notified according to current procedures for quality defect issues.
Whom to contact
The Norwegian Medical Products Agency
Unit for Correct Use of Medicinal Products + Unit for Pharmacovigilance: adr@noma.no
The European Medicines Agency
Emerging safety issues: P-PV-emerging-safety-issue@ema.europa.eu
Notifications of temporary or permanent cessation, suspension or withdrawal of the product form the market: withdrawnproducts@ema.europa.eu.