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Adapted guidelines on labeling and packaging of human medicines

FAMHP

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.

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