Exemption to enable timely access to radiopharmaceuticals and RAI

A new exemption will address the current difficulties in obtaining supplies of radiopharmaceuticals and radiopharmaceutical active ingredients (RAI) from a licensed manufacturer in a timely manner during the COVID-19 pandemic.

Radiopharmaceuticals and RAI are routinely used in the diagnosis and treatment of many illnesses, and play a critical part in the healthcare of Australians. Radiopharmaceuticals and their actives decay at a rate, measured in half-life, which means they need to be manufactured and shipped rapidly to the patient for use.

The COVID-19 pandemic has caused a significant reduction (and in some cases total absence) of direct flights between capital cities, and in some situations it has not been possible for hospitals to obtain supplies of radiopharmaceuticals or of RAI when manufactured at an interstate location.

The purpose of the Therapeutic Goods Amendment (Radiopharmaceuticals and Radiopharmaceutical Active Ingredients) Regulations 2020 (the Regulations) is to amend the TG Regulations to provide an exemption, in Schedule 7 to the TG Regulations, from the operation of Part 3-3 of the Act for certain radiopharmaceuticals and RAI.

The exemption enables specified persons within public and private hospitals and public institutions that do not hold a manufacturing licence under the Act to manufacture radiopharmaceuticals or RAI for the treatment of a patient in another State or Territory, so that the radiopharmaceuticals or RAI can be transported to the patient in a timely manner.

The exemption will be reviewed at an appropriate time when the current COVID-19 circumstances change. Accordingly, hospitals or public institutions should not seek to rely on the new exemption as a long-term option for manufacturing radiopharmaceuticals or RAI without a licence under the Act.

The full document and accompanying explanatory statement are available on the Federal Register of Legislation.

Feedback

The TGA welcomes feedback that helps processes be improved. Any feedback regarding these changes may be given to the TGA via the email info@tga.gov.au.