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Dossier documents matrix: Module 2-5

3 June 2013

Module 2

Category 1/category 2 applications - Module 2
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 2.1 Table of contents Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory
Module 2.2 Introduction Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory
Module 2.3 Quality overall summary Mandatory Mandatory Mandatory Mandatory Not required Mandatory
Module 2.4 Nonclinical overview Mandatory Mandatory Mandatory Mandatory May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements.
Module 2.5 Clinical overview Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory
Module 2.6 Nonclinical overview Mandatory Mandatory Mandatory May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements.
Module 2.7 Clinical overview Mandatory Mandatory Mandatory Mandatory Mandatory May be required. Refer to part A of this document for Module 1 requirements.

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Category 1/category 2 applications - Module 2
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 2.1 Table of contents Mandatory Mandatory Mandatory Mandatory Mandatory Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 2.2 Introduction Mandatory Mandatory Mandatory Mandatory Mandatory Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 2.3 Quality overall summary Mandatory Mandatory May be required. Refer to part A of this document for Module 1 requirements. Not required Not required Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 2.4 Nonclinical overview May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 2.5 Clinical overview Mandatory Mandatory Mandatory Mandatory Mandatory Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 2.6 Nonclinical overview May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 2.7 Clinical overview May be required. Refer to part A of this document for Module 1 requirements. Mandatory Mandatory Mandatory Mandatory Not required May be required. Refer to part A of this document for Module 1 requirements.

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Category 3 applications - Module 2
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 2.1 Table of contents May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 2.2 Introduction May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 2.3 Quality overall summary Mandatory Mandatory Not required Mandatory
Module 2.4 Nonclinical overview Not required Not required Not required Not required
Module 2.5 Clinical overview Not required Not required Not required Not required
Module 2.6 Nonclinical overview Not required Not required Not required Not required
Module 2.7 Clinical overview Not required Not required Not required Not required

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Modules 3-5

Category 1/category 2 applications - other modules
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 3—Quality Mandatory Mandatory Mandatory Mandatory Not required Mandatory
Module 4—Nonclinical Mandatory Mandatory Mandatory May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements.
Module 5—Clinical Mandatory Mandatory Mandatory Mandatory Mandatory May be required. Refer to part A of this document for Module 1 requirements.
Module 5.3.1 Reports of biopharmaceutic studies May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 5.3.2 Pharmacokinetic studies using human biomaterials May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. Not required
 

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Category 1/category 2 applications - other modules
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 3—Quality Mandatory Mandatory May be required. Refer to part A of this document for Module 1 requirements. Not required Not required Not required Not required
Module 4—Nonclinical May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 5—Clinical May be required. Refer to part A of this document for Module 1 requirements. Mandatory Mandatory Mandatory Mandatory Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 5.3.1 Reports of biopharmaceutic studies May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. Not required May be required. Refer to part A of this document for Module 1 requirements. Not required May be required. Refer to part A of this document for Module 1 requirements.
Module 5.3.2 Pharmacokinetic studies using human biomaterials May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. May be required. Refer to part A of this document for Module 1 requirements. Not required May be required. Refer to part A of this document for Module 1 requirements.

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Category 3 applications - other modules
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 3—Quality Mandatory Mandatory Not required Mandatory
Module 4—Nonclinical Not required Not required Not required Not required
Module 5—Clinical Not required Not required Not required Not required
Module 5.3.1 Reports of biopharmaceutic studies Not required Not required Not required Not required
Module 5.3.2 Pharmacokinetic studies using human biomaterials Not required Not required Not required Not required

Application types G and H are shown as Caegory 3 application. They may be Cat 1/2 or Cat 3 depending on whether they are supported by clinical, nonclinical or bioavailability data (Cat 1/2) or not (Cat 3). Cat 1/2 G and H are not included in the dossier in the table. If nonclinical (Module 4), clinical (Module 5) or bio-availability (Module 5.3) data are submitted, relevant Module 2 summaries and overviews will be required. Modules 1.8, 1.9 and 1.11 may also be required, depending on the application.

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