Module 1 AU |
1.0 |
Correspondence
|
1.0.1 |
Cover letter
|
1.0.2 |
Lifecycle management tracking table
|
1.0.3 |
Response to request for information
|
1.2 |
Administrative Information
|
1.2.1 |
Application forms
|
1.2.2 |
Pre-submission details
|
1.2.3 |
Patent certification
|
1.2.4 |
Change in sponsor
|
1.3 |
Medicine information and labelling
|
1.3.1 |
Product information and package insert
|
1.3.1.1 |
Product information - clean
|
1.3.1.2 |
Product information - annotated
|
1.3.1.3 |
Package insert
|
1.3.2 |
Consumer medicines information
|
1.3.2.1 |
Consumer medicines information - clean
|
1.3.2.2 |
Consumer medicines information -annotated
|
1.3.3 |
Label mock-ups and specimens
|
1.4 |
Information about the Experts
|
1.4.1 |
Quality
|
1.4.2 |
Nonclinical
|
1.4.3 |
Clinical
|
1.5 |
Specific requirements for different types of applications
|
1.5.1 |
Literature-based submission documents
|
1.5.2 |
Orphan drug designation
|
1.5.3 |
Genetically modified organisms consents
|
1.5.4 |
Additional trade name declarations
|
1.5.5 |
Co-marketed medicines declarations
|
1.5.6 |
Combination medicine consent
|
1.5.7 |
OTC product assurances
|
1.5.8 |
Umbrella brand assessment
|
1.6 |
Master files and certificates of suitability
|
1.6.1 |
Relevant external sources
|
1.6.2 |
Applicant's declaration
|
1.6.3 |
Letters of access
|
1.7 |
Compliance with meetings and pre- submission processes
|
1.7.1 |
Details of compliance with pre-submission meeting outcomes
|
1.7.2 |
Details of any additional data to be submitted
|
1.7.3 |
Declaration of compliance with pre-submission planning form and planning letter
|
1.8 |
Information relating to pharmacovigilance
|
1.8.1 |
Pharmacovigilance systems
|
1.8.2 |
Risk management plan
|
1.9 |
Summary of biopharmaceutic studies
|
1.9.1 |
Summary of bioavailability or bioequivalence study
|
1.9.2 |
Justification for not providing biopharmaceutic studies
|
1.10 |
Information relating to paediatrics
|
1.11 |
Foreign regulatory information
|
1.11.1 |
Foreign regulatory status
|
1.11.2 |
Foreign product information
|
1.11.3 |
Data similarities and differences
|
1.11.4 |
Foreign evaluation reports
|
1.12 |
Antibiotic resistance data
|