OTC dossier documents matrix

Related information

V1.2 June 2017

11 July 2017

Introduction

The OTC Dossier Documents Matrix (the 'matrix') provides a summary of the documents required for each application level (N1, N2, N3, N4, N5, CN, C1, C2, C3 or C4).

Use the matrix after you have determined the appropriate application level to obtain an 'at a glance' indication of which documents are to be provided.

The document requirements are described in the matrix as:

  • R: the stated document(s) are required for a valid application.
  • D: the provision of the document(s) is dependent on regulatory requirements for the particular dossier. The information included in CTD Module 1 will provide assistance in determining whether or not the documents will be required.
  • O: the provision of the document(s) is optional. There is no requirement for the document to be submitted with the application. However, the document(s) can be provided if the applicant considers the information is relevant to the application.
  • NA: the document(s) are not relevant and should not be submitted with the application.
Module 1
Module Name N1 N2 N3 N4 N5 CN C1 C2 C3 C4 Comment/Reference Recommended file/folder name
Table of Contents R R R R R O R R R R The main Table of Contents should be located in the top level folder
1.0.1 Cover letter (letter of application) R R R R R NA R R R R 101-cover
1.0.3 Response to request for information (including screening questions) D D D D D NA D D D D 103-response
1.2.3 Patent certification D D D D D NA D D D D Not applicable for applications submitted under section 9D of the Act 123-pat-cert
1.3.1 Product Information and package insert D D D D D D D D D D 131-pi
1.3.1.1 Product information - clean 1311-pi-clean
1.3.1.2 Product information - annotated 1312-pi-annotated
1.3.1.3 Package insert 1313-pack-ins
1.3.2 Consumer medicine information D D D D D D D D D D 132-cmi
1.3.2.1 Consumer medicine information - clean 1321-cmi-clean
1.3.2.2 Consumer medicine information - annotated 1322-cmi-annotated
1.3.3 Label mock-ups and specimens R R R R R D D D D D 133-mock-ups
1.4 Information about the experts NA NA NA D D NA NA NA D D 14-experts
1.4.1 Quality 141-quality
1.4.2 Nonclinical 142-nonclinical
1.4.3 Clinical 143-clinical
1.5 Specific requirements for different types of applications D D D D D D D D D D 15-specific
1.5.1 Literature-based submission documents NA NA NA D D NA NA NA D D 151-lit-based
1.5.5 Co-marketed medicine declarations (letters of authorisation) D D D D D D D D D D 155-co-marketed
1.5.7 OTC medicine assurances R R D D D D D D D D 157- assurance
1.5.8 Umbrella branding assessment NA NA NA D D NA NA NA D D 158-umbrella-br-assess
1.6 Master files and certificates of suitability NA NA O O D NA NA O O O 16- master-files
1.6.1 Relevant external sources 161-ext-sources
1.6.2 Applicant's declaration 162-app-decl
1.6.3 Letters of access 163-loa
1.7 Compliance with meetings and pre-submission processes NA NA NA NA NA NA NA NA NA NA
1.8 Information relating to pharmacovigilance Not expected for OTC applications
1.9 Summary of biopharmaceutic studies NA NA NA D D NA NA NA D D 19-biopharm
1.9.1 Summary of bioavailability or bioequivalence study 191-ba-be
1.9.2 Justification for not providing biopharmaceutic studies 192-justification
1.10 Information relating to paediatrics Not expected for OTC applications
1.11 Foreign regulatory information NA NA O O O NA NA O O O 111-foreign
1.11.1 Foreign regulatory status 1111-status
1.11.2 Foreign product information 1112-pi
1.11.3 Data similarities and differences 1113-similarities
1.11.4 Foreign evaluation reports 1114-eval-reports
1.12 Antibiotic resistance data Not expected for OTC applications
Module 2
Module Name N1 N2 N3 N4 N5 CN C1 C2 C3 C4 Comment/Reference Recommended folder name
2.2 Introduction NA NA D D D NA NA D D D 22-intro
2.3 Quality overall summary NA NA NA D D NA NA NA NA NA 23-qos
2.4 Nonclinical overview NA NA NA D D NA NA NA D D 24-nonclin-over
2.5 Clinical overview NA NA NA D D NA NA NA D D 25-clin-over
2.6 Nonclinical written and tabulated summaries NA NA NA D D NA NA NA D D 26-nonclin-sum
2.7 Clinical summary NA NA NA D D NA NA NA D D 27-clin-sum
Other modules
Module Name N1 N2 N3 N4 N5 CN C1 C2 C3 C4 Comment/Reference Recommended folder name
3 Quality D R R R R D D D D D Guidelines on quality aspects of OTC medicines

How to access a pdf document

For full list of recommended folder names, refer Appendix 3: General Consideration for the CTD Modules

4 Nonclinical study reports NA NA NA D D NA NA NA D D Guidelines on OTC applications for new substances

How to access a pdf document

For full list of recommended folder names, refer Appendix 3: General Consideration for the CTD Modules

5 Clinical study reports NA NA NA D D NA NA NA D D Guidelines on efficacy and safety aspects of OTC medicines

How to access a pdf document

For full list of recommended folder names, refer Appendix 3: General Consideration for the CTD Modules

5.3.1 Reports of biopharmaceutic studies NA NA NA D D NA NA NA D D Guidelines on efficacy and safety aspects of OTC medicines 531-rep-biopharm-stud
Version history
Version Description of change Author Effective date
V1.0 Original publication OMA-OTCME April 2013
V2.0
  • Code M for mandatory changed to R for required
  • Removed the New Zealand specific requirements
  • Changed numbering to align with the TGA format for Module 1
  • Amended Module 1.5 to remove Module 3 specific requirements and N2 level assurances and to add umbrella branding assessment and co-marketed medicine declaration
OTC Medicines and Regulatory Guidance Team November 2015
V2.1 Update to reflect the new notification process (CN) commencing 1 July 2017. OTC Medicines Evaluation Section / Scientific Operations Management Section June 2017