Exporting medicines from Australia
1. Introduction
Safety and quality in medicines are not just a local matter. The increasing globalisation of trade means that our responsibilities continue beyond the limit of our territorial waters.
The Therapeutic Goods Act 1989 applies to both the supply of therapeutic goods in Australia and the export of therapeutic goods from Australia.
As highlighted elsewhere in this information, a key requirement of the legislation is that all therapeutic goods must be included in the Australian Register of Therapeutic Goods (ARTG), including those that are exported.
This information describes the process and controls you need to be aware of when applying to export therapeutic goods.
2. Aim of export guidelines
When people use medicines they make assumptions about them: that the medicines are safe, and that someone has checked them in terms of quality.
Australia has a good international reputation as a place where there are standards in place to protect consumers who buy and use medicines.
The system of co-regulation - the industry and TGA working together to set and maintain rules and procedures - is part of what makes for safety and security when using medicines.
It is also important to ensure that exports, particularly to those countries that do not have a comparable assessment regime to Australia, are of suitable quality.
The aim of TGA export guidelines is to ensure that:
- substandard medicines are not exported from Australia;
- medicines do not leave Australia without the knowledge of the product sponsor and can be traced in the event of a product recall;
- exports are consistent with the World Health Organization (WHO) anti-counterfeiting measures (counterfeit medicines are a multi-billion dollar international problem).
Increasingly, countries are also requiring assurances of the quality of manufacture and assessment in the country of origin, as an initial step in their approval process for imported medicines.
3. Export scenarios
There are several common situations in which people seek to gain approval for export:
- Export of medicines for commercial supply
<http://www.tga.gov.au/docs/html/export/expmedcomm.htm> - Export of medicines for donation or humanitarian purposes
<http://www.tga.gov.au/docs/html/export/expmeddon.htm> - Export of human blood/tissue and related materials
<http://www.tga.gov.au/docs/html/export/expblood.htm>