The guidelines on labeling of medicines have been adapted. With these adaptations, the guidelines are more in line with the European and other national and international guidelines.

Main changes are:

  • Information in braille: the strength and/or pharmaceutical form only have to be added on the packaging of medicines if different strengths and/or pharmaceutical forms of this medicine exist. In case the strength is in micrograms, it is sufficient to mention ‘mcg’ in braille.
  • Unique identifiers (2D matrix code and human readable information) have to be added according to the QRD-template.
  • The definition of small packages has been expanded.
  • The definition and submission of mock-ups have been added.
  • Information on the use of trade marks, symbols ® and TM, or ‘brand of’: these marks are not accepted due to their promotional nature and as they are not useful for the patient. However, there have been some exceptions.
  • Information on the use of logos and QR codes.
  • Additional section on the labeling of combination packages and labeling of homeopathic medicines.

The complete guideline on labeling of medicines can be consulted here.

Share This