Exporting medicines from Australia - operational guidelines
These guidelines should be read in conjunction with the document Policy for the Export of Medicines from Australia <http://www.tga.gov.au/docs/html/export/exppol.htm> which outlines the objectives of the Australian regulatory system for export medicines and the relevant legislative framework.
The aim of these guidelines is to enhance transparency in the operations of the Export Medicines Unit of the TGA and ensure consistency in the administrative processes which support the Therapeutic Goods legislation.
Exporting medicines from Australia - operational guidelines (pdf,115kb)
Contents
- Commercial export of medicines
- Export of medicines for donation or humanitarian purposes
- Export of human blood/tissue
- Assessment pathways
- Separate and distinct goods
- Standards
- The assessment process
- Goods exported as bulk product
- Stability studies and shelf life
- Manufacture - Good Manufacturing Practice
- Exporting medicines which have been approved for supply in Australia
- Updating the ARTG record
- Label warning statements, material of human/animal origin, new substances and presentation of the product
- Application forms and guides to completing the forms
- Target timeframes - making sure that your application is not refused or delayed unnecessarily
- Future directions for the regulation of export medicines
- Appendix 1 - Interpretation of "name" for goods in the ARTG
- Appendix 2 - Changes table for solely for export medicines