Articles

We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.

We have accepted a court-enforceable undertaking from Your Solution Compounding Pharmacy Pty Ltd, regarding advertising of prescription-only compounded medicines for weight-loss.

Following our Essential Principles presentations on 11-12 September 2024, we have collated questions asked into themes to simplify finding information of relevance to you.

We have accepted an enforceable undertaking from 2San Pty Ltd in relation to breaches of the Therapeutic Goods Act 1989. This relates to the company's unlawful import and supply of medical devices.

The company imported medical devices not included in the Australian Register of Therapeutic Goods. They supplied these devices to a national retailer, who then sold them to the public.

Amendments to the Therapeutic Goods Regulations 1990 (Schedule 5, item 6) have been made resulting in compounded GLP-1 RA products no longer being able to be compounded by pharmacists and supplied to patients.

To help sponsors and manufacturers transition to new manufacturer evidence.

Transition period for accepting ISO 13485 ends 26 May 2023.

The TGA will recognise the extended transition for the European Union Medical Device Regulation (EU MDR).

Supplies of Ozempic (semaglutide) have begun distribution in Australia but will remain quite limited for some time.

The TGA has approved the first two nasal combination self-tests (for use at home) that detect both COVID-19 and influenza viral infections in humans.

New legislative instrument

Invitation to the National Measurement Institute's mask/respirator testing forum.

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

Therapeutic Goods Order No. 1 of 2010.