The following documents are provided for historical purposes only. Please see Australian Regulatory Guidelines for Prescription Medicines for up-to-date guidance.

• Australian regulatory guidelines for prescription medicines (pdf,926kb)
• Australian regulatory guidelines for prescription medicines (Microsoft Word,4.96Mb)*

• Appendix 1: Glossary of terms (pdf,251kb)
• Appendix 1: Glossary of terms (Microsoft Word,3.40Mb)*

• Appendix 2: Fees and charges (pdf,212kb)
• Appendix 2: Fees and charges (Microsoft Word,3.39Mb)*

• Appendix 3: Justification for a particular route of evaluation (pdf,216kb)
• Appendix 3: Justification for a particular route of evaluation (Microsoft Word,3.39Mb)*

• Appendix 4: Drug safety and evaluation branch clinical evaluation sections (pdf,103kb)
• Appendix 4: Drug safety and evaluation branch clinical evaluation sections (Microsoft Word,56kb)

• Appendix 5: Conduct of meetings between TGA and sponsors (pdf,210kb)
• Appendix 5: Conduct of meetings between TGA and sponsors (Microsoft Word,3.38Mb)*

• Appendix 6: Notification and submission of new data (pdf,206kb)
• Appendix 6: Notification and submission of new data (Microsoft Word,3.38Mb)*

• Appendix 7: Certified product details (pdf,197kb)
• Appendix 7: Certified product details (Microsoft Word,2.96Mb)*

• Appendix 8: Product information (pdf,267kb)
• Appendix 8: Product information (Microsoft Word,3.38Mb)*

• Appendix 12: Changes to the quality information of registered medicines (pdf,509kb)*
• Appendix 12: Changes to the quality information of registered medicines (Microsoft Word,3.97Mb)*

• Appendix 13: Self-assessable changes for biological products (pdf,215kb)
• Appendix 13: Self-assessable changes for biological products (Microsoft Word,3.39Mb)*

• Appendix 14: Stability testing (pdf,304kb)
• Appendix 14: Stability testing (Microsoft Word,3.82Mb)*

• Appendix 16: Preservative efficacy testing (pdf,195kb)
• Appendix 16: Preservative efficacy testing (Microsoft Word,3.80Mb)*

• Appendix 17: Microbial quality of medicines (pdf,210kb)
• Appendix 17: Microbial quality of medicines (Microsoft Word,3.39Mb)*

• Appendix 20: Supplementary guidelines for radiopharmaceuticals (pdf,202kb)
• Appendix 20: Supplementary guidelines for radiopharmaceuticals (Microsoft Word,3.38Mb)*

• Appendix 21: Medicines produced by genetic manipulation (pdf,204kb)
• Appendix 21: Medicines produced by genetic manipulation (Microsoft Word,3.80Mb)*

• Appendix 22: Colourings permitted in medicines for oral use (pdf,185kb)
• Appendix 22: Colourings permitted in medicines for oral use (Microsoft Word,2.96Mb)*

• Appendix 23: Supplementary non-clinical guidelines (pdf,195kb)
• Appendix 23: Supplementary non-clinical guidelines (Microsoft Word,2.96Mb)*

• Appendix 24: Information about therapeutic goods and the use of human embryos, human embryonic stem cells and materials derived therefrom (pdf,216kb)
• Appendix 24: Information about therapeutic goods and the use of human embryos, human embryonic stem cells and materials derived therefrom (Microsoft Word,3.86Mb)*