OTC dossier documents matrix
V1.2 June 2017
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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.
On this page: Module 1 | Module 2 | Other modules
| 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 | 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 |
| 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 | For full list of recommended folder names, refer Appendix 3: General Consideration for the CTD Modules - external site |
| 4 | Nonclinical study reports | NA | NA | NA | D | D | NA | NA | NA | D | D | Guidelines on OTC applications for new substances | For full list of recommended folder names, refer Appendix 3: General Consideration for the CTD Modules - external site |
| 5 | Clinical study reports | NA | NA | NA | D | D | NA | NA | NA | D | D | Guidelines on efficacy and safety aspects of OTC medicines | For full list of recommended folder names, refer Appendix 3: General Consideration for the CTD Modules - external site |
| 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 | Description of change | Author | Effective date |
|---|---|---|---|
| V1.0 | Original publication | OMA-OTCME | April 2013 |
| V2.0 |
| 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 |