Updated guidelines for the labelling and packaging of medicinal products for human use

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 have recently been updated.

The applicable “Labelling of medicinal products” guidelines within the context of a new marketing authorisation (MA), renewal or variation of a MA for medicinal products for human use, have 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.

Last updated on
03/04/2020