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 confidence that there is consistency between the ARTG and the label/advertising.
  • By implication – by including the qualifier in the overall product presentation, such as the name of the medicine and/or directions for use (for example, the name ‘Women’s Multivitamins’ suggests the vitamins are formulated for women).
  • If the qualifier is included in the overall product presentation, such as the name of the medicine  (for example the name Women’s Multi), then the qualifier (for example “in females”) doesn’t need to be entered for each of the product indications in the ARTG, although this is still a recommended approach by the TGA. If the qualifier is included in the directions for use, but not expressed explicitly in the name of the medicine, then the qualifier must be entered for every relevant indication in the ARTG. This impacts medicines with multiple dosages for multiple target populations (for example Cold Relief with dosages for adults and children). In such cases, the relevant indications must be entered once on the ARTG for each of the relevant target populations. As an example, a product with directions for use  in children, teens and adults will require the indications to be listed three times. Once without the qualifier, once with the qualifier in children and once with the qualifier in adolescents.

We also need to be careful if separate directions for use are provided for older adults, OR if a product is presented with a photo of an elderly couple of woman, eg a calcium formulation, as this may require the indications to be listed with a separate population qualifier. Products with indications listed on the ARTG without a population qualifier can only be directed for use in the general Australian adult population:

  • males and females
  • that are generally healthy
  • aged 18–65 years
  • socio-culturally similar to the Australian population

Can a population group be specified in the directions for use without having to qualify the indication in the ARTG?

Sponsors are not required to qualify their indications in the ARTG in order to provide directions for use for different population groups within the general Australian population (the default population) on their product label (e.g. in ‘women’, ‘in adults’, ‘in men’). However, directions for use cannot specify a target population, directly or by implication, that is not consistent with the information included in the ARTG for the medicine.

The inclusion of specific target populations that are not within the general Australian adult population in the directions for use (e.g. children dosage, teenagers, or suitable for use in breastfeeding women, etc.) will stipulate the requirement of population qualifier in the ARTG indications.

Sponsors are also required to hold evidence to support the use(s) in those populations.