Product information for medicinal products
Published:
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Updated:
Changes
- : Gathered information from two pages to one.
- : Improved heading and language according to the Norwegian page
All medicinal products marketed in Norway must have approved product information. The product information shall comply with templates and guidelines, and the MAH is responsible to keep the product information updated in accordance with current knowledge.
What is product information for medicinal products?
Product information for medicinal products comprises the Summary of Product Characteristics (SmPC/SPC), the package leaflet (PL), labelling text and mock-ups. Before medicinal products may be marketed in Norway, the product information shall be submitted to and approved by the NOMA.
High-quality product information contributes to better user information and correct use of medicinal products. For as long as the medicinal product holds a marketing authorisation in Norway, the SmPC and the PL must be kept under continuous review and updated accordingly.
Please see Submission of product information.
Summary of Product Characteristics (SmPC)
The Summary of Product Characteristics (SmPC) is a document containing information about the medicinal product based on documentation relating to its quality, manufacture, and preclinical and clinical studies. The intended audience of the SmPC is healthcare professionals with a medical or scientific background.
Package leaflet
The package leaflet contains, among other things, information on why and how the medicinal product should be used, possible adverse reactions, and whether the medicinal product may be used during pregnancy or breastfeeding. The intended audience of the package leaflet is the patient or user of the medicinal product.
The readability of the package leaflet must be tested in cooperation with a target group of patients to ensure that it is easy to read, clear, and user-friendly. Please refer to further information on readability testing.
There are also electronic package leaflets available.
Labelling
Labelling comprises both the labelling text and the mock-ups. The labelling text is based on information from the Summary of Product Characteristics (SmPC) and contains all information that shall appear on the packaging. Mock-ups are drafts of the medicinal products packaging. All text included in the mock-ups shall be in accordance with the approved labelling text.
Please refer to Packaging for further information.