Human Immunodeficiency Virus (HIV) self-tests that are approved in Australia

The following conditions are imposed on HIV self-tests included in the Australian Register of Therapeutic Goods (ARTG)

Supply

1. The person in relation to whom the HIV self-test (the device) is included in the Australian Register of Therapeutic Goods (the sponsor) must ensure that the device is only supplied to one or more of the following:
   1. a business, organisation or institution (including a pharmacy) that employs or engages individuals who have received appropriate training (in any form) in relation to the correct use and performance of the device, and the interpretation of the test result;
   2. a person directly through the website of the sponsor or a pharmacy mentioned in paragraph (a).

Customer support services

2. The sponsor must publish on its website a simple, clear and effective instructional video, demonstrating the correct use and performance of the device, and the interpretation of the test result.
3. The sponsor must:
   1. provide information about relevant support services and confirmatory testing available in each state and territory with the supply of each device; and
   2. publish the information mentioned in paragraph (a) on its website.
4. The sponsor must take steps to ensure that a business, organisation or institution (including a pharmacy) mentioned in condition (1)(a) has access to, and encourages the dissemination of, the following by any means:
   1. information about the correct use and performance of the device, and the interpretation of the test result, consistent with the information provided in the instructional video mentioned in condition (2); and
   2. information about the support services and confirmatory testing mentioned in condition (3).
5. The sponsor must provide a telephone helpline that:
   1. provides customer support about the correct use and performance of the device, and the interpretation of the test result; and
   2. operates (as a minimum) between 9 am and 7 pm (AEST), or 9 am and 8 pm (AEDT), 7 days per week.
6. The sponsor must ensure that the operators providing customer support services mentioned in condition (5) have received training in the delivery and administration of HIV testing, in accordance with the requirements of the National HIV testing policy - external site (which may be accessed via the ASHM website at https://www.ashm.org.au - external site).

Post market surveillance reports

7. The sponsor must provide a post market surveillance report, containing the following information, to the Therapeutic Goods Administration (at the email address postmarketdevices@health.gov.au) for each reporting period specified in condition (8), before 1 October after that reporting period:
   1. the numbers of tests sold both in Australia and overseas;
   2. any adverse events, including numbers of any reported false positive or false negative results, both in Australia and overseas;
   3. reported problems, issues or complaints associated with the use or interpretation of the device, both in Australia and overseas.
8. Each of the following is a reporting period:
   1. the period beginning on the day when this condition is imposed, and ending at the end of the next 30 June;
   2. each of the next five financial years.

Record keeping

9. The sponsor must maintain records that demonstrate that the sponsor has complied with each of the conditions mentioned above (relating to supply, customer support services and post market surveillance reports) and provide those records to the Secretary on request.