OTC substance reports

Published: 12/10/2023

Changes

An OTC substance report can replace a clinical summary in an application for OTC status or for a change of OTC status.

The Norwegian Medical Products Agency (NOMA) has published OTC substance reports for a number of active substances that are classified as not subject to medical prescription. These reports define the OTC indication, posology and pack sizes exempt from medical prescription, and gives an overview of the recommended wording in Norwegian for the package leaflet and labeling.

The OTC substance reports are updated as needed and published on the Norwegian version of this page. You can switch to the Norwegian version using the link "Vis denne siden på norsk" at the top of the page.

For comments or questions, please contact the Unit for regulatory affairs after MA (see contact details below).

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