Marketing authorisation holders of a medicinal product for human use are required to follow certain guidelines for the labelling and packaging of medicinal products. These guidelines (“Labelling of medicinal products” ) have recently been updated.

The main changes are a clarification in the sections “Readability” and “Sufficient distinction” of the mock-ups in order to avoid medication errors. The guidelines have now been brought into line with the European directives and other national or international agreements.


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