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Dossier documents matrix: Module 1

3 June 2013

Module 1

Category 1/category 2 applications - Module 1
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 Human embryo/embryonic stem cell declaration Mandatory Mandatory Mandatory Mandatory Mandatory Mandatory
Module 1.3.4 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.
Category 1/category 2 applications - Module 1
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.
Category 3 applications - Module 1
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