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

date: 14/01/2025

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 guidelines for the labelling and packaging of medicinal products have been adapted to the most recent European directives and other national and international agreements.

The main changes are the following.

  • Section 3.1.1 Name of the medicinal product: updated definition.
  • Section 3.1.3 List of excipients: standard declarations for fluorinated greenhouse gases.
  • Section 3.1.19 Specific requirements and Section 5.7 Labelling of parallel imported medicinal products: clarification of code number application for narcotic drugs and psychotropic substances.
  • Section 3.2.5 Others: blister packaging with empty units and perforated blister packaging. 
  • Section 4.6 Mobile Scanning Technology: QR codes and presence of the corresponding URL.

More information
Guideline: Labelling of medicinal products

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