eCTD Filing Types for AU
Calyx RIM provides the following filing types for all application types associated with Australia (AU).
AU v0.90
This table list the eCTD code and the applicable DTD or Schema for each Filing Type.
| Filing Type (Display) | Applicable DTD/Schema | eCTD Code | Available for Application Type |
|---|---|---|---|
| A - NCE New Chemical Entity | au-0-90 | seq-type-1 | CTA, NDA |
| A - NCE New Salt or Ester of Existing Active Ingredient | au-0-90 | seq-type-2 | CTA, NDA |
| A - NCE Similar Biological Medicinal Product | au-0-90 | seq-type-3 | CTA, NDA |
| B - New Combination | au-0-90 | seq-type-4 | CTA, NDA |
| C - Extension of Indication | au-0-90 | seq-type-5 | CTA, NDA |
| D - New Generic Medicine | au-0-90 | seq-type-6 | CTA, NDA |
| E - Additional Tradename | au-0-90 | seq-type-7 | CTA, NDA |
| F - Major Variation - New Strength | au-0-90 | seq-type-8 | CTA, NDA |
| F - Major Variation - New Dosage Form | au-0-90 | seq-type-9 | CTA, NDA |
| F - Major Variation - New Route of Administration | au-0-90 | seq-type-10 | CTA, NDA |
| F - Major Variation - Change in Patient Group | au-0-90 | seq-type-11 | CTA, NDA |
| F - Major Variation - Change of Dosage | au-0-90 | seq-type-12 | CTA, NDA |
| G - Minor Variation, New Register Entry - Change of Formulation | au-0-90 | seq-type-13 | CTA, NDA |
| G - Minor Variation, New Register Entry - New Container Type | au-0-90 | seq-type-14 | CTA, NDA |
| Change of Tradename | au-0-90 | seq-type-15 | CTA, NDA |
| H - Minor Variation, Not Resulting in a New Register Entry | au-0-90 | seq-type-16 | CTA, NDA |
| J - PI Change requiring evaluation | au-0-90 | seq-type-17 | CTA, NDA |
| K - PI Change without Data | au-0-90 | seq-type-18 | CTA, NDA |
| Rolling Review | au-0-90 | seq-type-19 | CTA, NDA |
| OTC - N1 | au-0-90 | seq-type-20 | CTA, NDA |
| OTC - N2 | au-0-90 | seq-type-21 | CTA, NDA |
| OTC - N3 | au-0-90 | seq-type-22 | CTA, NDA |
| OTC - N4 | au-0-90 | seq-type-23 | CTA, NDA |
| OTC - N5 | au-0-90 | seq-type-24 | CTA, NDA |
| OTC - C1 | au-0-90 | seq-type-25 | CTA, NDA |
| OTC - C2 | au-0-90 | seq-type-26 | CTA, NDA |
| OTC - C3 | au-0-90 | seq-type-27 | CTA, NDA |
| OTC - C4 | au-0-90 | seq-type-28 | CTA, NDA |
| OTC - New Active Ingredient | au-0-90 | seq-type-29 | CTA, NDA |
| Ingredient - New | au-0-90 | seq-type-30 | CTA, NDA |
| Ingredient - Variation | au-0-90 | seq-type-31 | CTA, NDA |
| Complementary Medicine - New | au-0-90 | seq-type-32 | CTA, NDA |
| Complementary Medicine - Variation | au-0-90 | seq-type-33 | CTA, NDA |
| Biologicals - Class 1 | au-0-90 | seq-type-34 | CTA, NDA |
| Biologicals - Class 2 | au-0-90 | seq-type-35 | CTA, NDA |
| Biologicals - Class 3 | au-0-90 | seq-type-36 | CTA, NDA |
| Biologicals - Class 4 | au-0-90 | seq-type-37 | CTA, NDA |
| Biologicals - Variation | au-0-90 | seq-type-38 | CTA, NDA |
| Medical Devices | au-0-90 | seq-type-39 | CTA, NDA |
| ASMF / DMF | au-0-90 | seq-type-40 | CTA, NDA |
| Plasma Master File (PMF) | au-0-90 | seq-type-41 | CTA, NDA |
| Tissue Master File (TMF) | au-0-90 | seq-type-42 | CTA, NDA |
| Biological Master File (BMF) | au-0-90 | seq-type-43 | CTA, NDA |
| Pharmacovigilance | au-0-90 | seq-type-44 | CTA, NDA |
| Supplementary information | au-0-90 | seq-type-45 | CTA, NDA |
| Baseline | au-0-90 | seq-type-46 | CTA, NDA |
| Periodic Safety Update Report | au-0-90 | seq-type-47 | CTA, NDA |
| Risk Management Plan | au-0-90 | seq-type-48 | CTA, NDA |
| Clinical Trial Application | au-0-90 | seq-type-49 | CTA, NDA |
| Pre-Submission Meeting Documentation | au-0-90 | seq-type-50 | CTA, NDA |
| Pre-Submission Planning Form | au-0-90 | seq-type-51 | CTA, NDA |
| Undefined Regulatory Activity* | au-0-90 | seq-type-52 | CTA, NDA |
AU v3.0
This table list the eCTD code and the applicable DTD or Schema for each Filing Type.
| Filing Type (Display) | Applicable DTD/Schema | eCTD Code | Available for Application Type |
|---|---|---|---|
| A - NCE New Chemical Entity | au-3-0 | seq-type-1 | CTA, NDA |
| A - NCE New Salt or Ester of Existing Active Ingredient | au-3-0 | seq-type-2 | CTA, NDA |
| A - NCE Similar Biological Medicinal Product | au-3-0 | seq-type-3 | CTA, NDA |
| B - New Combination | au-3-0 | seq-type-4 | CTA, NDA |
| C - Extension of Indication | au-3-0 | seq-type-5 | CTA, NDA |
| D - New Generic Medicine | au-3-0 | seq-type-6 | CTA, NDA |
| E - Additional Tradename | au-3-0 | seq-type-7 | CTA, NDA |
| F - Major Variation - New Strength | au-3-0 | seq-type-8 | CTA, NDA |
| F - Major Variation - New Dosage Form | au-3-0 | seq-type-9 | CTA, NDA |
| F - Major Variation - New Route of Administration | au-3-0 | seq-type-10 | CTA, NDA |
| F - Major Variation - Change in Patient Group | au-3-0 | seq-type-11 | CTA, NDA |
| F - Major Variation - Change of Dosage | au-3-0 | seq-type-12 | CTA, NDA |
| G - Minor Variation, New Register Entry - Change of Formulation | au-3-0 | seq-type-13 | CTA, NDA |
| G - Minor Variation, New Register Entry - New Container Type | au-3-0 | seq-type-14 | CTA, NDA |
| Change of Tradename | au-3-0 | seq-type-15 | CTA, NDA |
| H - Minor Variation, Not Resulting in a New Register Entry | au-3-0 | seq-type-16 | CTA, NDA |
| J - PI Change requiring evaluation | au-3-0 | seq-type-17 | CTA, NDA |
| OTC - N1 | au-3-0 | seq-type-20 | CTA, NDA |
| OTC - N2 | au-3-0 | seq-type-21 | CTA, NDA |
| OTC - N3 | au-3-0 | seq-type-22 | CTA, NDA |
| OTC - N4 | au-3-0 | seq-type-23 | CTA, NDA |
| OTC - N5 | au-3-0 | seq-type-24 | CTA, NDA |
| OTC - C1 | au-3-0 | seq-type-25 | CTA, NDA |
| OTC - C2 | au-3-0 | seq-type-26 | CTA, NDA |
| OTC - C3 | au-3-0 | seq-type-27 | CTA, NDA |
| OTC - C4 | au-3-0 | seq-type-28 | CTA, NDA |
| Ingredient - New | au-3-0 | seq-type-30 | CTA, NDA |
| Ingredient - Variation | au-3-0 | seq-type-31 | CTA, NDA |
| Complementary Medicine - New | au-3-0 | seq-type-32 | CTA, NDA |
| Complementary Medicine - Variation | au-3-0 | seq-type-33 | CTA, NDA |
| Biologicals - Class 1 | au-3-0 | seq-type-34 | CTA, NDA |
| Biologicals - Class 2 | au-3-0 | seq-type-35 | CTA, NDA |
| Biologicals - Class 3 | au-3-0 | seq-type-36 | CTA, NDA |
| Biologicals - Class 4 | au-3-0 | seq-type-37 | CTA, NDA |
| Biologicals - Variation | au-3-0 | seq-type-38 | CTA, NDA |
| ASMF / DMF | au-3-0 | seq-type-40 | CTA, NDA |
| Plasma Master File (PMF) | au-3-0 | seq-type-41 | CTA, NDA |
| Tissue Master File (TMF) | au-3-0 | seq-type-42 | CTA, NDA |
| Biological Master File (BMF) | au-3-0 | seq-type-43 | CTA, NDA |
| Pharmacovigilance | au-3-0 | seq-type-44 | CTA, NDA |
| Supplementary information | au-3-0 | seq-type-45 | CTA, NDA |
| Baseline | au-3-0 | seq-type-46 | CTA, NDA |
| Periodic Safety Update Report | au-3-0 | seq-type-47 | CTA, NDA |
| Risk Management Plan | au-3-0 | seq-type-48 | CTA, NDA |
| Clinical Trial Application | au-3-0 | seq-type-49 | CTA, NDA |
| Undefined Regulatory Activity* | au-3-0 | seq-type-52 | CTA, NDA |
| 9D(1) - Correction of Register Entry | au-3-0 | seq-type-53 | CTA, NDA |
| 9D(2) - Safety Related Request | au-3-0 | seq-type-54 | CTA, NDA |
| 9D(3) - Change to PI (not J) | au-3-0 | seq-type-55 | CTA, NDA |
| Change of Sponsor | au-3-0 | seq-type-56 | CTA, NDA |
| Withdrawal | au-3-0 | seq-type-57 | CTA, NDA |
AU v3.1
This table list the eCTD code and the applicable DTD or Schema for each Filing Type.
| Filing Type (Display) | Applicable DTD/Schema | eCTD Code | Available for Application Type |
|---|---|---|---|
| A - NCE New Chemical Entity | au-3-1 | seq-type-1 | CTA, NDA |
| A - NCE New Salt or Ester of Existing Active Ingredient | au-3-1 | seq-type-2 | CTA, NDA |
| A - NCE Similar Biological Medicinal Product | au-3-1 | seq-type-3 | CTA, NDA |
| B - New Combination | au-3-1 | seq-type-4 | CTA, NDA |
| C - Extension of Indication | au-3-1 | seq-type-5 | CTA, NDA |
| D - New Generic Medicine | au-3-1 | seq-type-6 | CTA, NDA |
| E - Additional Tradename | au-3-1 | seq-type-7 | CTA, NDA |
| F - Major Variation - New Strength | au-3-1 | seq-type-8 | CTA, NDA |
| F - Major Variation - New Dosage Form | au-3-1 | seq-type-9 | CTA, NDA |
| F - Major Variation - New Route of Administration | au-3-1 | seq-type-10 | CTA, NDA |
| F - Major Variation - Change in Patient Group | au-3-1 | seq-type-11 | CTA, NDA |
| F - Major Variation - Change of Dosage | au-3-1 | seq-type-12 | CTA, NDA |
| G - Minor Variation, New Register Entry - Change of Formulation | au-3-1 | seq-type-13 | CTA, NDA |
| G - Minor Variation, New Register Entry - New Container Type | au-3-1 | seq-type-14 | CTA, NDA |
| Change of Tradename | au-3-1 | seq-type-15 | CTA, NDA |
| H - Minor Variation, Not Resulting in a New Register Entry | au-3-1 | seq-type-16 | CTA, NDA |
| J - PI Change requiring evaluation | au-3-1 | seq-type-17 | CTA, NDA |
| OTC - N1 | au-3-1 | seq-type-20 | CTA, NDA |
| OTC - N2 | au-3-1 | seq-type-21 | CTA, NDA |
| OTC - N3 | au-3-1 | seq-type-22 | CTA, NDA |
| OTC - N4 | au-3-1 | seq-type-23 | CTA, NDA |
| OTC - N5 | au-3-1 | seq-type-24 | CTA, NDA |
| OTC - C1 | au-3-1 | seq-type-25 | CTA, NDA |
| OTC - C2 | au-3-1 | seq-type-26 | CTA, NDA |
| OTC - C3 | au-3-1 | seq-type-27 | CTA, NDA |
| OTC - C4 | au-3-1 | seq-type-28 | CTA, NDA |
| Ingredient - New | au-3-1 | seq-type-30 | CTA, NDA |
| Ingredient - Variation | au-3-1 | seq-type-31 | CTA, NDA |
| Complementary Medicine - New | au-3-1 | seq-type-32 | CTA, NDA |
| Complementary Medicine - Variation | au-3-1 | seq-type-33 | CTA, NDA |
| Biologicals - Class 1 | au-3-1 | seq-type-34 | CTA, NDA |
| Biologicals - Class 2 | au-3-1 | seq-type-35 | CTA, NDA |
| Biologicals - Class 3 | au-3-1 | seq-type-36 | CTA, NDA |
| Biologicals - Class 4 | au-3-1 | seq-type-37 | CTA, NDA |
| Biologicals - Variation | au-3-1 | seq-type-38 | CTA, NDA |
| ASMF / DMF | au-3-1 | seq-type-40 | CTA, NDA |
| Plasma Master File (PMF) | au-3-1 | seq-type-41 | CTA, NDA |
| Tissue Master File (TMF) | au-3-1 | seq-type-42 | CTA, NDA |
| Biological Master File (BMF) | au-3-1 | seq-type-43 | CTA, NDA |
| Pharmacovigilance | au-3-1 | seq-type-44 | CTA, NDA |
| Supplementary information | au-3-1 | seq-type-45 | CTA, NDA |
| Baseline | au-3-1 | seq-type-46 | CTA, NDA |
| Periodic Safety Update Report | au-3-1 | seq-type-47 | CTA, NDA |
| Risk Management Plan | au-3-1 | seq-type-48 | CTA, NDA |
| Clinical Trial Application | au-3-1 | seq-type-49 | CTA, NDA |
| Undefined Regulatory Activity* | au-3-1 | seq-type-52 | CTA, NDA |
| 9D(1) - Correction of Register Entry | au-3-1 | seq-type-53 | CTA, NDA |
| 9D(2) - Safety Related Request | au-3-1 | seq-type-54 | CTA, NDA |
| 9D(3) - Change to PI (not J) | au-3-1 | seq-type-55 | CTA, NDA |
| Change of Sponsor | au-3-1 | seq-type-56 | CTA, NDA |
| Product Withdrawal | au-3-1 | seq-type-57 | CTA, NDA |
| Provisional registration - TGA initiated variation | au-3-1 | seq-type-58 | CTA, NDA |
| Notification | au-3-1 | seq-type-59 | CTA, NDA |
| CN | au-3-1 | seq-type-60 | CTA, NDA |
| Extension of provisional registration | au-3-1 | seq-type-61 | CTA, NDA |
| Duplicate | au-3-1 | seq-type-62 | CTA, NDA |