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Australian regulatory guidelines for prescription medicines (ARGPM) (archived)

21 May 2013

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

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AttachmentSize
File Australian regulatory guidelines for prescription medicines (docx)5MB
PDF icon Australian regulatory guidelines for prescription medicines (pdf)927KB
File ARGPM Appendix 1: Glossary of terms (docx)3MB
PDF icon ARGPM Appendix 1: Glossary of terms (pdf)251KB
File ARGPM Appendix 2: Fees and charges (docx)3MB
PDF icon ARGPM Appendix 2: Fees and charges (pdf)213KB
File ARGPM Appendix 3: Justification for a particular route of evaluation (docx)3MB
PDF icon ARGPM Appendix 3: Justification for a particular route of evaluation (pdf)216KB
Microsoft Office document icon ARGPM Appendix 4: Drug safety and evaluation branch clinical evaluation sections (doc)56KB
PDF icon ARGPM Appendix 4: Drug safety and evaluation branch clinical evaluation sections (pdf)104KB
File ARGPM Appendix 5: Conduct of meetings between TGA and sponsors (docx)3MB
PDF icon ARGPM Appendix 5: Conduct of meetings between TGA and sponsors (pdf)211KB
File ARGPM Appendix 6: Notification and submission of new data (docx)3MB
PDF icon ARGPM Appendix 6: Notification and submission of new data (pdf)207KB
File ARGPM Appendix 7: Certified product details (docx)3MB
PDF icon ARGPM Appendix 7: Certified product details (pdf)197KB
PDF icon ARGPM Appendix 8: Product information (pdf)267KB
File ARGPM Appendix 8: Product information (docx)3MB
File ARGPM Appendix 12: Changes to the quality information of registered medicines: notification, self-assessment and prior approval (docx)4MB
PDF icon ARGPM Appendix 12: Changes to the quality information of registered medicines: notification, self-assessment and prior approval (pdf)510KB
File ARGPM Appendix 13: Self-assessable changes for biological products (docx)3MB
PDF icon ARGPM Appendix 13: Self-assessable changes for biological products (pdf)216KB
File ARGPM Appendix 14: Stability testing (docx)4MB
PDF icon ARGPM Appendix 14: Stability testing (pdf)305KB
File ARGPM Appendix 16: Preservative efficacy testing (docx)4MB
PDF icon ARGPM Appendix 16: Preservative efficacy testing (pdf)195KB
File ARGPM Appendix 17: Microbial quality of medicines (docx)3MB
PDF icon ARGPM Appendix 17: Microbial quality of medicines (pdf)211KB
File ARGPM Appendix 20: Supplementary guidelines for radiopharmaceuticals (docx)3MB
PDF icon ARGPM Appendix 20: Supplementary guidelines for radiopharmaceuticals (pdf)202KB
File ARGPM Appendix 21: Medicines produced by genetic manipulation (docx)4MB
PDF icon ARGPM Appendix 21: Medicines produced by genetic manipulation (pdf)204KB
File ARGPM Appendix 22: Colourings permitted in medicines for oral use (docx)3MB
PDF icon ARGPM Appendix 22: Colourings permitted in medicines for oral use (pdf)186KB
File ARGPM Appendix 23: Supplementary non-clinical guidelines (docx)3MB
PDF icon ARGPM Appendix 23: Supplementary non-clinical guidelines (pdf)196KB
File ARGPM Appendix 24: Information about therapeutic goods and the use of human embryos, human embryonic stem cells and materials derived therefrom (docx)4MB
PDF icon ARGPM Appendix 24: Information about therapeutic goods and the use of human embryos, human embryonic stem cells and materials derived therefrom (pdf)216KB