Marketing complementary medicines with soft gel capsules for children

This information is still current as at 15 February 2019.

Information for sponsors

In response to a consumer query, the TGA has investigated potential safety issues with complementary medicines with soft gel capsule dosage forms in children. As part of this investigation, the TGA sought independent expert medical advice, which stated that these products may pose a choking hazard for children, especially those aged under five years.

As a result, there is a risk that such products may be non-compliant with the requirements set out in the Therapeutic Goods Act 1989 (the Act).

The expert medical advice received by the TGA stated that:

• medicines with soft gel capsules dosage forms pose a choking risk to children of all ages, but especially to children aged under five years
• as the age of the child being given the medicine increases, the risk of choking reduces.

The TGA has also published a safety advisory regarding this choking hazard for children.

Regulatory obligations

It is the responsibility of sponsors to be aware of their regulatory obligations before launching a new product onto the Australian market.

Sponsors of complementary medicines should refer to the Australian Regulatory Guidelines for Complementary Medicines (ARGCM), which has been recently updated to increase its useability for sponsors and contains clear and easy to understand information on how to meet the requirements set out in the Act.

Sponsors of complementary medicines listed on the Australian Register of Therapeutic Goods (ARTG) are required to certify at the time of listing that their product is compliant with the Act. The requirements include that the medicine is safe for the purposes for which it is to be used and that the presentation of the medicine is not unacceptable. The TGA refers to the overall presentation of a product when evaluating compliance.

Sponsors and prospective sponsors of complementary medicines with soft gel capsule dosage forms should consider:

• restricting dosage instructions to children aged five years and over
• including a label advisory statement to the effect 'not intended to be consumed by children under five years of age'
• including a label statement advising that the product is only to be used under adult supervision
• fitting the product with child-resistant packaging
• the viability of alternative dosage instructions for children under five years, for example squirting the contents of the capsule into food or drink.

For further information about regulatory obligations for marketing complementary medicines with soft gel capsule dosage forms for children, email nonprescriptionmedicines@health.gov.au.