ForsideEnglishRegulatory affairsOTC-statusHarmonization of packaging leaflet and labelling for OTC-medicinal products with an OTC substance report 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. SideinnholdThe 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. Publisert: 19.08.2016 Fant du det du lette etter? Ja Ja Nei Nei Så bra! Hva var det du lette etter på denne siden? Kan du fortelle hva du ikke fant? Vennligst ikke oppgi navn eller kontaktinformasjon i dette feltet, men send oss en e-post hvis du har konkrete spørsmål. Send inn tilbakemelding Skriv ut
