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Harmonization 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.

The Norwegian Medical Products Agency urges all marketing authorization holders of OTC-medicinal products to:

  1. Harmonize existing package leaflets and labelling for OTC-medicinal products in accordance with the OTC substance report by submitting a notification. This is free of charge as long as the changes do not widen the already approved OTC-indication/posology for the medicinal product. If the harmonization includes a broadening of the indication it will be charged as an OTC application.

  2. To compile separate package leaflets for OTC packs (OTC-PIL) in accordance with the OTC substance report for medicinal products in prescription group CF. OTC-PIL can be submitted for approval with the next variation for the medicinal product or as a separate notification, which will be free of charge. 

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