Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023

Summary

The Therapeutic Goods Legislation Amendment (2023 Measures No. 2) Regulations 2023 (the Amendment Regulations) was approved by the Executive Council on 23 November and was registered on the Federal Register of Legislation on 27 November 2023. The Amendment Regulations amend the Therapeutic Goods Regulations 1990 and the Therapeutic Goods (Medical Devices) Regulations 2002 to implement the following main measures:

• extending transitional timeframes for two key sets of medical device reforms to align with similar moves in the EU – reforms relating to the reclassification of specified kinds of devices, for example, devices intended by the manufacturer to be used in direct contact with the heart, central circulatory system or the central nervous system of a patient, and reforms relating to personalised medical devices;
• better ensuring the safe use of medical devices in clinical trials in Australia by making it clear that authorised persons have the power to enter the site of a clinical trial operating under the Clinical Trial Notification (CTN) and take certain steps to ensure that the trial is being conducted in accordance with good clinical practice;
• reducing regulatory burden for patients and medical practitioners by introducing a number of unapproved medicinal cannabis products that may be supplied under the Authorised Prescriber scheme without the need for an ethics committee approval;
• reducing regulatory burden for sponsors of influenza, Respiratory Syncytial Virus (RSV) and COVID-19 vaccines by reducing application and evaluation fees an application to register a vaccine that targets a new strain of one of those disease and that is closely related to a vaccine that is already included in the Australian Register of Therapeutic Goods in relation to the applicant;
• supporting the safe use of sunscreen preparations by removing outdated exemption provisions for sunscreen preparations with a SPF of less than 4;
• making a small number of other minor amendments including to correct unintended errors.

Commencement

The amendments relating to sunscreen preparations will commence on 1 January 2024. All other measures commenced on 28 November 2023.