As an outcome from our consultation on Building a more robust supply of medicines, the Therapeutic Goods Act 1989 (Act) was amended to include expanded powers to import and supply important discontinued medicines and clarifications to shortage reporting requirements.
What is changing
Import and supply of overseas medicines
We can now approve the temporary import or supply of an overseas medicine that could act as a substitute for a medicine that was previously registered in Australia, where it is in the interest of public health. This includes medicines that are cancelled or suspended from the Australian Register of Therapeutic Goods (ARTG). This means that if a medicine is cancelled or suspended from the ARTG, but is still clinically important, we can approve supply of a substitute overseas medicine to allow continued patient access.
Notification of changes to medicine shortage periods and resolution
Sponsor obligations to notify us of changes to a medicine shortage period and of the shortage resolution have been clarified:
- Changes to the shortage duration or end date and resolution of the shortage must be reported to the TGA.
- Medicine shortage notifications made on or after 22 September 2023 must specify the period of the shortage of the medicine in Australia.
- Sponsors must notify us of changes to the period and resolution of a medicine shortage where the medicine shortage period ends on or after 22 September 2023, regardless of whether the shortage was first notified before, on or after that date.
- Reporting timeframes are in line with the initial impact rating. Notification should occur as soon as possible in the interest of affected patients.
- Changes must be reported within 2 working days of discovering the change to the shortage period or end date for critical shortages
- Changes must be reported within 10 working days of discovering the change to the period or end date for all other shortages.
For detailed information on the mandatory reporting scheme for medicine shortages (including permanent discontinuations) and our approach to non-compliance with that scheme, see Medicine shortages in Australia: Reporting obligations and the TGA’s compliance framework.
Why these changes have been introduced
These Act changes have been introduced to help us alleviate the effects of medicine shortages on patients and provide up-to-date information to patients and health professionals.
Previously, we could only grant temporary approval for import and supply of a substitute medicine from overseas if the Australian medicine was included in the ARTG. This created a problem when medicines were discontinued and cancelled from the ARTG but remained clinically important for patients with no other treatment options.
This additional management option will help us to minimise the impact of medicine discontinuations by providing continued patient access to important medicines.
We aim to keep our Medicine Shortage Reports Database as up-to-date as possible to assist health professionals and patients to manage shortages. Information in this database is based on supply details reported to us by sponsors. Sponsors already provide updates to their shortage notifications and confirm the shortage resolution. Clarifying sponsor responsibilities to do so will help ensure that sponsors advise the TGA promptly of changes to shortages so that we can make this information available to health professionals and patients.
Implementation
Key changes to the framework for import and supply of unapproved medicines under section 19A of the Act:
| What | When |
|---|---|
| Changes to import or supply of overseas medicines | |
| New application type – section 19A(2A). Previously ARTG registered goods could act as a substitute for the goods but are cancelled or suspended and the goods are from a country specified by the Secretary.* | Applies from 22 March 2023 |
| New application type – section 19A(2B). Previously ARTG registered goods could act as a substitute for the goods but are cancelled or suspended and the goods are from a country not specified by the Secretary.* | Applies from 22 March 2023 |
| Notify changes to a medicine shortage period or resolution | |
| Period of shortage – section 3(1), 30EIA, 30EF(4)(a) A medicine shortage notification must specify the period of the shortage of the medicine in Australia#. | Applies to medicine shortage notifications made on or after 22 September 2023 |
| Reporting changes to the period of a medicine shortage – section 30EFA Changes to the period and resolution of a medicine shortage must be notified. Legislated timeframes are as soon as possible or within 2 or 10 days, in line with the status and reporting timeframes of the initial shortage notification#. | Applies to medicine shortage notifications with an end date on or after 22 September 2023, regardless of when the shortage was first notified. |
*Other requirements apply, see our 19A guidance for industry.
# See our guidance on Reporting medicine shortages and discontinuations in Australia - Guidance for sponsors.
Further information
We have updated the following relevant guidance documents and forms to reflect these changes:
- Section 19A: Guidance for industry
- Section 19A application form to import and supply substitute medicines
- Medicine Shortages in Australia -Reporting obligations and the TGA's compliance framework
- Reporting medicine shortages and discontinuations in Australia - Guidance for sponsors
If you have further questions, please contact the Medicine shortages section.
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