Module 1 Category 1/Category 2 applications fee type A, B, C and D
| TGA's application fee type is … | A - NCE | B - New Combination | C - Extension of indication | D - New generic medicine | |||
|---|---|---|---|---|---|---|---|
| Applying for a … | New chemical entity | New salt or ester of existing active ingredient | Similar biological medicinal product | ||||
| Module 1.0.0 | Electronic lodgement cover sheet | mandatory | Mandatory | Mandatory | Mandatory | Not required | Mandatory |
| Module 1.0.1 | Letter of application | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.0.2 | Responses to questions for information | Not required | Not required | Not required | Not required | Not required | Not required |
| Module 1.1 | Comprehensive table of contents | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.2.1 | Application form | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.2.2 | Pre-submission details | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.2.3 | Patent certification | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. |
| Module 1.3.1 | Product information and package insert | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.3.2 | Consumer medicines information | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.3.3 | Label mock-ups and specimens | Mandatory | Mandatory | Mandatory | Mandatory | May be required. Refer to Module 1 requirements. | Mandatory |
| Module 1.4 | Information about experts & expert declarations | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.5.1 | Literature-based submission documents | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. |
| Module 1.5.2 | Orphan drug designation | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. |
| Module 1.5.3 | Genetically modified organisms consents | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. |
| Module 1.5.4 | Additional trade name declarations | Not required | Not required | Not required | Not required | Not required | Not required |
| Module 1.5.5 | Co-marketed medicines declarations | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. |
| Module 1.6 | Drug and plasma master files and certificates of suitability | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required | May be required. Refer to Module 1 requirements. |
| Module 1.7 | Good manufacturing practice | Mandatory | Mandatory | Mandatory | Mandatory | Not required | Mandatory |
| Module 1.8 | Compliance with meetings and pre-submission processes | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.9 | Individual patient data declaration | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. |
| Module 1.10 | Overseas regulatory status | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.11 | Summary of biopharmaceutic studies | Mandatory | Mandatory | Mandatory | Mandatory | Not required | Mandatory |
| Module 1.12 | References to paediatric development program | Mandatory | Mandatory | Not required | Mandatory | Mandatory | Not required |
| Module 1.13 | Information relating to pharmacovigilance | Mandatory | Mandatory | Mandatory | Mandatory | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. |
| Module 1 Annex I | Antibiotic resistance data | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required |
| Module 1 Annex II | Overseas evaluation reports | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. |
Module 1 Category 1/Category 2 applications fee type E, F and J
| TGA's application fee type is … | F - Major variation | E - Additional tradename | J - PI Change requiring evaluation | |||||
|---|---|---|---|---|---|---|---|---|
| Applying for a … | New strength | New dosage form | New route of administration | Change in patient group (not decrese) | Change of dosage | |||
| Module 1.0.0 | Electronic lodgement cover sheet | Not required | Not required | Not required | Not required | Not required | Not required | Not required |
| Module 1.0.1 | Letter of application | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.0.2 | Responses to questions for information | Not required | Not required | Not required | Not required | Not required | Not required | Not required |
| Module 1.1 | Comprehensive table of contents | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.2.1 | Application form | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.2.2 | Pre-submission details | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Not required | Mandatory |
| Module 1.2.3 | Patent certification | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required |
| Module 1.3.1 | Product information and package insert | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.3.2 | Consumer medicines information | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | May be required. Refer to Module 1 requirements. |
| Module 1.3.3 | Human embryo/embryonic stem cell declaration | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Not required |
| Module 1.3.4 | Label mock-ups and specimens | Mandatory | Mandatory | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Mandatory | May be required. Refer to Module 1 requirements. |
| Module 1.4 | Information about experts & expert declarations | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Not required | Mandatory |
| Module 1.5.1 | Literature-based submission documents | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required | May be required. Refer to Module 1 requirements. |
| Module 1.5.2 | Orphan drug designation | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required |
| Module 1.5.3 | Genetically modified organisms consents | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required |
| Module 1.5.4 | Additional trade name declarations | Not required | Not required | Not required | Not required | Not required | Mandatory | Not required |
| Module 1.5.5 | Co-marketed medicines declarations | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. |
| Module 1.6 | Drug and plasma master files and certificates of suitability | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required | Not required | Not required | Not required | Not required |
| Module 1.7 | Good manufacturing practice | Mandatory | Mandatory | Not required | Not required | Not required | Mandatory | Not required |
| Module 1.8 | Compliance with meetings and pre-submission processes | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | May be required. Refer to Module 1 requirements. | Mandatory |
| Module 1.9 | Individual patient data declaration | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required | May be required. Refer to Module 1 requirements. |
| Module 1.10 | Overseas regulatory status | Mandatory | Mandatory | Mandatory | Mandatory | Mandatory | Not required | Mandatory |
| Module 1.11 | Summary of biopharmaceutic studies | Mandatory | Mandatory | Mandatory | Not required | May be required. Refer to Module 1 requirements. | Not required | May be required. Refer to Module 1 requirements. |
| Module 1.12 | References to paediatric development program | Mandatory | Mandatory | Mandatory | Not required | Not required | Not required | Not required |
| Module 1.13 | Information relating to pharmacovigilance | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required | Not required |
| Module 1 Annex I | Antibiotic resistance data | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required | May be required. Refer to Module 1 requirements. |
| Module 1 Annex II | Overseas evaluation reports | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required | May be required. Refer to Module 1 requirements. |
Module 1 Category 3 applications fee type G and H
| TGA's application fee type is … | G - Minor variation, new Register entry | H - Minor variation, not resulting in a new Register Entry | |||
|---|---|---|---|---|---|
| Applying for a … | Change of formulation | New container type | Change of tradename | ||
| Module 1.0.0 | Electronic lodgement cover sheet | Not required | Not required | Not required | Not required |
| Module 1.0.1 | Letter of application | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.0.2 | Responses to questions for information | Not required | Not required | Not required | Not required |
| Module 1.1 | Comprehensive table of contents | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.2.1 | Application form | Mandatory | Mandatory | Mandatory | Mandatory |
| Module 1.2.2 | Pre-submission details | Not required | Not required | Not required | Not required |
| Module 1.2.3 | Patent certification | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required |
| Module 1.3.1 | Product information and package insert | Mandatory | Mandatory | Mandatory | May be required. Refer to Module 1 requirements. |
| Module 1.3.2 | Consumer medicines information | Mandatory | Mandatory | Mandatory | May be required. Refer to Module 1 requirements. |
| Module 1.3.3 | Human embryo/embryonic stem cell declaration | Mandatory | Mandatory | Mandatory | Not required |
| Module 1.3.4 | Label mock-ups and specimens | May be required. Refer to Module 1 requirements. | Mandatory | Mandatory | May be required. Refer to Module 1 requirements. |
| Module 1.4 | Information about experts & expert declarations | Mandatory | Mandatory | Not required | May be required. Refer to Module 1 requirements. |
| Module 1.5.1 | Literature-based submission documents | Not required | Not required | Not required | Not required |
| Module 1.5.2 | Orphan drug designation | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | Not required |
| Module 1.5.3 | Genetically modified organisms consents | Not required | Not required | Not required | Not required |
| Module 1.5.4 | Additional trade name declarations | Not required | Not required | Not required | Not required |
| Module 1.5.5 | Co-marketed medicines declarations | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. |
| Module 1.6 | Drug and plasma master files and certificates of suitability | May be required. Refer to Module 1 requirements. | Not required | Not required | May be required. Refer to Module 1 requirements. |
| Module 1.7 | Good manufacturing practice | Not required | Not required | Not required | May be required. Refer to Module 1 requirements. |
| Module 1.8 | Compliance with meetings and pre-submission processes | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. | May be required. Refer to Module 1 requirements. |
| Module 1.9 | Individual patient data declaration | Not required | Not required | Not required | Not required |
| Module 1.10 | Overseas regulatory status | Not required | Not required | Not required | Not required |
| Module 1.11 | Summary of biopharmaceutic studies | Not required | Not required | Not required | Not required |
| Module 1.12 | References to paediatric development program | Not required | Not required | Not required | Not required |
| Module 1.13 | Information relating to pharmacovigilance | Not required | Not required | Not required | Not required |
| Module 1 Annex I | Antibiotic resistance data | Not required | Not required | Not required | Not required |
| Module 1 Annex II | Overseas evaluation reports | Not required | Not required | Not required | Not required |
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