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 Medicines Agency urges all marketing authorization holders of OTC-medicinal products to:
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.
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.