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Harmonization of packaging leaflet and labelling for OTC-medicinal products with an OTC substance report

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Changes

  • : Added information regarding harmonisation of existing package leaflets and labelling with the OTC active 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 authorisation holders of OTC-medicinal products to:

  1. Harmonise 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 harmonisation 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.

How should existing package leaflets and labeling be harmonised with the active substance report?

As a notification: If the harmonisation is of a editorial nature, does not change the approved OTC status, and is in line with the approved indication and dosage in the medicinal product's SmPC. For example, purely linguistic adjustments of the OTC indication and/or dosage. Such a notification is classified as type IAin C.z and is not invoiced. The NOMA accepts partial harmonisation for medicinal products where the indication in the SmPC is less extensive than the indication in the active substance report.

As a variation application: If the harmonisation involves an extension of the OTC status and the MA holder wishes to change the OTC indication in accordance with the OTC active substance report. For example, an extension of the OTC indication in line with the indication in the OTC active substance report. Such a change must be applied for as an OTC status change and is classified as a type II C.z variation and charged accordingly.