Are population qualifiers mandatory?

An indication must be qualified on medicine labels (or other advertising), either explicitly or by implication, if it is qualified in the ARTG entry. There is no need to add a qualifier on a medicine label (or other advertising) if there are no qualifiers added on the ARTG.

Indications can be qualified, either:

  • Explicitly – by using the qualifier directly in relation to the indications entered in the ARTG (which sponsors can select using the drop down lists in ELF) and on the product label and advertising material. This is optional, however, it is the recommended approach as it puts beyond doubt what the indications for the medicine are and will give sponsors c