New practice on naming medicines
The Danish Medicines Agency ("DMA") updated its practice for the naming of medicines, herbal medicines, and cannabis end products on 30 October 2023.
According to section 58(3) of the Danish Medicines Act, the name of a medicine must not be misleading with regard to the composition, effect or other properties of the product and must not be likely to cause confusion with other medicines.
The DMA assesses that a proper noun, by which is meant personal name or a place name, is likely to mislead in the sense of the Danish Medicines Act if it is included in the name of a medicine. For this reason, it now appears from the M A's description of the national practice for the naming of medicines that the name of a medicine must not consist of a proper noun. The practice covers herbal medicines and cannabis end products.
According to the DMA, the update is due to a desire for harmonization of naming practices within the EU and EMA, as well as clarifying the basis of evaluation in Denmark for naming medicines.
Want to know more?
If you wish to know more about the Danish Medicines Agency’s national practice on naming medicines, please contact Plesner's Life Science team.
Read more about the Danish Medicines Agency's national practice on the naming of medicines