Therapeutic Goods Administration (TGA) policy for the export of medicines from Australia
The key purpose of this document is to delineate the role of the TGA in export regulation. Part A of the document comprises the policy framework or strategic commitments given by the TGA in relation to export regulation. These support and direct the TGA's export-related actions outlined in Part B.
Therapeutic Goods Administration (TGA) policy for the export of medicines from Australia (pdf,141kb)
Contents
- Introduction
- Background
- PART A: Policy framework
- A1. Quality and safety assurance for exports
- A2. Customer service and focus
- A3. Efficiency of domestic regulation
- A4. International obligations
- A5. Best regulatory practice
- A6. Risk-based regulation
- A7. Promotion of Australia's quality export certification processes
- PART B: TGA export-related regulatory and administrative actions
- B1. Regulatory role
- B2. Support role
- Attachment 1: Codified statements for export certificates
- Attachment 2: Decision tree for approval of solely for export listing
- Attachment 3: Sample Certificate of Pharmaceutical Product (CPP)
- Attachment 4: Sample Certificate of Listed Product (CLP)
- Attachment 5: Summary of the Australian regulatory controls over medicines for human use