Changes to nappy rash products

Changes will be made to the regulation of nappy rash products on 1 January 2020.

Some nappy rash products will become exempt from requirements under the Therapeutic Goods Act 1989 (the Act) to be entered in the Australian Register of Therapeutic Goods (ARTG) and made in accordance with Good Manufacturing Practice (GMP). This will apply to listed medicines and Class I medical devices which are indicated for the relief of nappy rash symptoms via a barrier effect only. The exemption will not apply to nappy rash preparations that are also indicated for other skin conditions.

Background

In 2017, the Government accepted recommendations 14, 23 and 48 from the Medicines and Medical Devices Regulation (MMDR) Review to carry out further reviews of the regulation of 'low risk' products. In conducting the further reviews, a series of targeted stakeholder consultations were held during late 2016 and early 2017.

A range of options for the future regulation of low risk products was released for public consultation on 31 March 2017 and over 1,000 submissions were received in response.

In December 2018, we confirmed that nappy rash products that are currently included in the ARTG as Class I medical devices or as listed medicines, will be declared exempt. We also noted that there would be no changes to nappy rash products that are entered in the ARTG as registered medicines.

What medicines does it apply to?

Any preparation which is a listed medicine or Class I medical device for topical use that protects against / provides relief from nappy rash by acting as a barrier. If relief of nappy rash symptoms are provided via another mechanism of action (e.g. the product has a physiological effect) it would not be within scope. It will also not apply to any product which is indicated for other skin conditions such as psoriasis, eczema or dermatitis.

How will they be exempt?

In order for these changes to be implemented, a declaration will be made under s41BD (3) of the Therapeutic Goods Act 1989 to declare Class I devices which meet the definition above to no longer to be medical devices. This will align the regulatory requirements for comparable nappy rash products.

Updates will then be made to the Therapeutic Goods Regulations 1990 to exempt applicable nappy rash products from the requirement to be entered in the Register and made in accordance with GMP standards. These changes will come into effect on 1 January 2020.

Ongoing requirements

The nappy rash products that are declared exempt will still be subject to any applicable standards for product quality, labelling and packaging, and with advertising requirements. They will also be subject to TGA recall provisions.