Medicinal products to be distributed without medical prescription
Published:
Changes
All medicinal products that are distributed without a prescription in Norway are called OTC (Over The Counter) medicines.
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 Medical Products 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.