2022/0162/B
EC/EFTA
BE Belgium
  • C10P - Pharmaceuticals
2022-06-20
2022-03-24

This draft pertains to the naming of medicinal products for human use authorised in Belgium.

Preliminary draft law setting out various provisions on health

The provision in question is an express normative provision stipulating that the invented name of a medicinal product shall not create confusion with other medicinal products, medical devices or food supplements. Nor shall the invented name of a medicinal product create confusion regarding its quality or other properties.
This rule will apply to ‘new’ medicinal products, i.e. those that have not yet received a ‘national’ marketing authorisation, and medicinal products already ‘nationally’ authorised, whose marketing authorisation holder applies for a name change.