Section 19A of the Therapeutic Goods Act 1989 allows medicines not currently included in the Australian Register of Therapeutic Goods (ARTG) to be imported into Australia and supplied
in place of a registered medicine that is unavailable or in short supply
or
- if relevant registered medicines do not exist but an application for a new medicine is being evaluated by the TGA.
Applying for section 19A approval to supply a medicine
Sponsors can apply for section 19A approval to supply medicines by completing the Section 19A application form. The guidance document, Section 19A: Guidance for industry provides detailed information to assist with the application process.
Any sponsor can apply to the TGA for approval to supply under section 19A; you do not need to be the sponsor of the registered medicine that is in short supply.
To support your application you will need to provide information on the availability of any registered suitable substitutes for the medicine in shortage. See the Section 19A: Guidance for industry for more details.
Applying for Pharmaceutical Benefits Scheme listing
If the registered medicine in shortage is listed on the Pharmaceutical Benefits Scheme (PBS) you are able to apply for listing of the section 19A medicine on the PBS. There are no fees associated with the temporary PBS listing of a section 19A medicine.
Information is available on the PBS Frequently Asked Questions webpage. Contact pbspricing@health.gov.au if you have any enquiries regarding the PBS listing process.
Legal requirements for approving a section 19A application
The TGA can consider the supply of a medicine under section 19A if:
- it is in the interests of public health; and
it is approved for general marketing in a foreign country
or
- it is under evaluation for registration on the ARTG
Information to consider before applying for a section 19A application
Section 19A approvals are
- subject to relevant conditions to minimise risks to consumers
- granted for a specified period, which usually relates to the period the registered medicine is unavailable or in short supply
- subject to the same pharmacovigilance activities (for example, adverse event reporting and recalls) and advertising restrictions as medicines registered on the ARTG.
If the overseas approval is not from one of a list of specified countries[1], you must provide additional information to confirm that the manufacturing and quality control procedures used in the production of the medicine are acceptable.
Publication of section 19A approvals
Information about medicines approved for supply under section 19A is published on the TGA's website on the Database of section 19A approvals.
Footnotes
| [1] | The current specified countries are Canada, France, Germany, Netherlands, New Zealand, Sweden, Switzerland, United Kingdom and United States of America. |
|---|