If a thorough investigation of the alert has not been able to exclude technical or end user errors, and there is a possibility for the pack to be a possible falsified medicine, NoMA shall be notified. The end user causing the alert shall preferably be the one that does the notification. Such notification is made via NoMAs dedicated form for this purpose (Melding om mulig forfalsket legemiddel), sent to FMDavvik@legemiddelverket.no.
If there is a confirmed falsification Nomvec has to ensure that the National Competent Authorities (here NoMA), the EMA and the EU Commission are informed, either by informing the parties themselves, or by ensuring that this is done by end user or MAH (according to Article 37 (d) in the Delegated Regulation). Nomvec therefore wishes to be informed about such cases. Please use our contact form.
See NoMA’s homepage for more information regarding notification of potential falsified medicinal products.