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OTC dossier documents matrix

Verson 1.0, March 2013

22 March 2013

Introduction

The OTC Dossier Documents Matrix (the 'matrix') provides a summary of which documents are required for each application level. The matrix is expected to be used after a sponsor has determined the appropriate application level for their application and is intended to provide 'at a glance' an indication of which documents are to be provided. The document requirements are described as:

  • M: where the stated document(s) are mandatory and are required to submit a valid application.
  • D: where the provision of the document(s) is dependent on regulatory requirements for the particular submission. For the Australian sponsors, the references to ARGOM will guide sponsors to the appropriate parts of the regulatory guidelines to assist in determining whether or not the documents will be required.
  • O: where the provision of the document(s) is optional. That is to say, there is no requirement or expectation from the regulator that the document(s) will be submitted with the application but that the document(s) could be provided where a sponsor considers the provision of the information may assist in the assessment of the application.
  • NA: where the document(s) are not relevant and should not be submitted with the application.
  • *: New Zealand specific: where an asterisk is included, documents are to be provided to Medsafe if available.

OTC dossier documents matrix

Module 1
Module Name N1 N2 N3 N4 N5 C1 C2 C3 C4 ARGOM reference Recommended folder name
Mod. 1.0.1 Letter of Application (cover letter) M M M M M M M M M Pre-market application & evaluation process chapter m1-0-1-letter-applic
Mod. 1.0.2 Responses to screening questions D D D D D D D D D Pre-market application & evaluation process chapter m1-0-2-responses-quest
Mod. 1.0.4 Letters of Authorisation M D* D* D* D* D* D* D* D* Pre-market application & evaluation process chapter m1-0-4-letter-authorisation
Mod. 1.1 Table of Contents M M M M M M M M M m1-1-toc
Mod. 1.2.1 Application Form
(where a paper copy of dossier provided)
M M M M M M M M M Pre-market application & evaluation process chapter m1-2-1-applic-form
Mod. 1.2.3 Patent certification D D D D D D D D D Pre-market application & evaluation process chapter m1-2-3-patent-certification
Mod. 1.3.1 Product Information / Data Sheet D D D D D D D D D Appendix 3, section 4 m1-3-1-proposed-pi
Mod. 1.3.1 Pack Insert D D D D D D D D D Appendix 3, sections 3.15-3.17 m1-3-1-proposed-packinsert
Mod. 1.3.2 Consumer Medicine Information D D D D D D D D D Appendix 3, section 5 m1-3-2-proposed-cmi
Mod. 1.3.4 Mock-ups and labelling specimens M M M M M D D D D Appendix 3, sections 1-3 m1-3-4-label-mock-up
Mod. 1.4 Info on Experts & Expert Declarations NA NA D D D NA NA D D m1-4-expert
m1-4-1-quality
m1-4-2-non-clinical
m1-4-3-clinical
Mod. 1.5 Levels N1 & N2: Finished product specification M M NA NA NA NA NA NA NA Appendix 2, section 7.1 m1-5-finished-product-spec
Mod. 1.5 Level N1: raw material specifications D NA NA NA NA NA NA NA NA Appendix 2, section 6 m1-5-raw-material-spec
Mod. 1.5 Level N2: Certificates of Analysis of finished product NA M NA NA NA NA NA NA NA Appendix 2, section 7 m1-5-cert-of-analysis
Mod. 1.5 Level N2: OTC new product applications level N2 – assurances NA M NA NA NA NA NA NA NA Pre-market application & evaluation process chapter m1-5-level-n2-assurances
Mod. 1.5 OTC Medicine Evaluation Analytical Validation Summary NA NA D* D* D* O* D* D* D* Appendix 2, section 7.9 m1-5-analytical-validation-summary
Mod. 1.5.1 Literature-based submissions document NA NA NA D D NA NA D D Appendix 1, section 2 m1-5-1-literature-based
Mod. 1.6 Drug and Plasma Master Files and Certificates of Suitability NA NA O* O* D NA O O O Appendix 2, section 2 m1-6-drug-master-files-cert-of-suitability
m1-6-1-dmf-pms-cos
m1-6-2-sponsors-declaration
m1-6-3-letters-of-access
m1-6-4-cert-of-suitability
Mod. 1.7 GMP
[In Australia evidence of GMP is generally not required in module 1.7 (except for active premixes) as it is provided in electronic application]
D D D D D D D D D Appendix 2, section 5 & section 2.1 m1-7-good-manufacturing-practice
m1-7-1-aust-mfrs
m1-7-2-os-mfrs
m1-7-3-os-mfrs-without-clearance
Mod. 1.9 Individual Patient Data Declaration NA NA NA D D NA NA D D m1-9-indiv-patient-data
Mod. 1.10 Overseas Regulatory Status O* O* O* D* D* O* O* D* D* m1-10-overseas-reg-status
m1-10-1-overseas-reg-status
m1-10-2-other-countries-pi
m1-10-2-1-us
m1-10-2-2-eu
m1-10-2-3-canada
m1-10-2-4-new-zealand
m1-10-3-dataset-similarities
Mod. 1.11 Summary of Biopharmaceutic Studies NA NA NA D D NA NA D D Appendix 1, section 6.1 m1-11-summary-biopharm-studies
m1-11-1-summary-biopharm-studies
m1-11-2-justification-no-biopharm-studies
Mod. 1.13 Information relating to pharmacovigilance O O O D D O O D D Appendix 1, section 5 m1-13-pharmacovigilance
m1-13-1-riskmgt-system
Mod. 1 Annex II Overseas Evaluation Reports NA NA O* O* O* NA O* O* O* m1-annex2-other-countries-evaluation-report
Module 2
Module Name N1 N2 N3 N4 N5 C1 C2 C3 C4 ARGOM reference Recommended folder name
Mod. 2.1 Table of Contents NA NA D D D NA D D D 21-toc
Mod. 2.2 Introduction NA NA D D D NA D D D 22-intro
Mod. 2.3 Quality Overall Summary NA NA D D D NA D D D 23-qos
Mod. 2.4 Non-clinical Overview NA NA NA* D D NA NA D D 24-nonclin-over
Mod. 2.5 Clinical Overview NA NA NA* D D NA NA D D 25-clin-over
Mod. 2.6 Non-clinical Summary NA NA NA D D NA NA D D 26-nonclin-sum
Mod. 2.7 Clinical Summary NA NA NA D D NA NA D D 27-clin-sum
Other Modules
Module Name N1 N2 N3 N4 N5 C1 C2 C3 C4 ARGOM reference Recommended folder name
Mod. 3 Quality NA NA M M M D D D D Appendix 2

For full list of recommended folder names, refer

How to access a pdf document

'Appendix 3: General Consideration for the CTD Modules (pdf,726kb)'

Mod. 4 Non-clinical NA NA NA D D NA NA D D Appendix 4
Mod. 5 Clinical NA NA NA D D NA NA D D Appendix 1
Mod. 5.3.1 Reports of Biopharmaceutic Studies NA NA NA D D NA NA D D Appendix 1 531-rep-biopharm-stud
Version history
Version Description of change Author Effective date
V1.0 Original publication OMA - OTCME April 2013