Product information for medicinal products
Published:
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Updated:
Changes
- : Improved heading and language according to the Norwegian page
The product information includes Summary of product characteristics (SmPC), package leaflet (PL), labelling text and mock-ups. Before marketing medicinal products in Norway, the product information shall be submitted and approved by the NoMA.
MAH responsibilites
To ensure that the product information is of good quality, it is important to use templates, standard sentences, guidelines and appendices where applicable. The marketing authorisation holder (MAH) is responsible for and shall ensure that the product information is of good quality and updated according to the last versions of templates and guidelines. The product information should be quality assured by a person who understands Norwegian medical terminology and patient-friendly medical language.
The SmPC and PL shall be adapted to their target group and must be easy to read and understand. It is important that the Norwegian translation of the product information has the same meaning as the English (faithful translation).
Labeling includes both labeling text and mock-ups. The labelling text is based on the information in the SmPC and all text on mock-ups shall be in accordance with the approved labeling text.