​

​​These products are classified as:

  • Prescription group F (Reseptgruppe F):  the active substance(s) is classified as a medicinal product for which a prescription is unnecessary
    or
  • Prescription group CF (Reseptgruppe CF):  the active substance(s) is subject to medical prescription, however some pack sizes, strengths, pharmaceutical forms etc. are given an exemption from medical prescription and can be distributed OTC).

Legal status for supply – national or European decision?

For medicinal products approved via the Decentralized, Mutual Recognition and National procedures, the legal status for supply is determined nationally by the Norwegian Medicines Agency. Guidance for the appointment of legal status for supply is provided for in A guideline on changing the classification for the supply of a medicinal product for human use, the Norwegian Regulation Forskrift om legemidler, and the EU Directive 2001/83/EC. The European Commission appoints the legal status for supply for medicinal products approved via the Centralized Procedure.

 

 

Application for OTC legal status and change of OTC legal statushttps://legemiddelverket.no/english/regulatory-affairs/otc-status/application-for-otc-legal-status-and-change-of-otc-legal-statusApplication for OTC legal status and change of OTC legal statusGuidelines for application for OTC legal status (CF/F) including risk minimization measures. 770
Harmonization of packaging leaflet and labelling for OTC-medicinal products with an OTC substance reporthttps://legemiddelverket.no/english/regulatory-affairs/otc-status/harmonization-of-packaging-leaflet-and-labelling-for-otc-medicinal-products-with-an-otc-substance-reportHarmonization of packaging leaflet and labelling for OTC-medicinal products with an OTC substance report​The information in labelling and packaging leaflets shall be clear and fit the target population.772
OTC substance reportshttps://legemiddelverket.no/english/regulatory-affairs/otc-status/otc-substance-reportsOTC substance reportsThe Norwegian Medicines Agency (NoMA) has published OTC substance reports for a number of active substances that are classified as not subject to medical prescription. 771

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