The TGA has published a new consultation Legislating regulatory categories for some boundary and combination products which are relevant to products sponsored by CMA members. The proposal would divide specific subcategories of the below products into different regulatory classifications: “Medical Devices”; “Medicines”; or “Medical Devices (exempt)”.

Products under the current proposal that are more likely to affect CMA members include:

- products for lice on the head and body

- oral care toothpastes

- compounded and uncompounded emollient and moisturising preparations for therapeutic use

- Ingested weight loss treatments.

The consultation, closing 6 August, seeks stakeholder views on:

- Whether legislating some products where possible to formally declare their regulatory category (e.g., medical device, not a medical device or other therapeutic good (OTG), will provide additional clarity for stakeholders.

- Whether a transitional period of five years is sufficient for sponsors of affected ARTG entries.

- Whether there are other boundary products that should be clarified (see CMA’s note on food-medicine interface in this alert).

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