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Please note: This version (V1.0) of the specification is acceptable until 30 June 2018. Version 2.0 becomes effective on 1 January 2018.
Folder and file structure
The structure of a NeeS format dossier[7] must conform to both:
- the Annex to the ICH guideline Organisation of the Common Technical Document for the Registration of Pharmaceuticals for Human Use (pdf,286kb) and
- the requirements set out in CTD Module 1 - Administrative information and prescribing information for Australia.
Name the root folder of the dossier with the eSubmission Identifier of the medicine followed by the subfolder name (sequence number) of four digits
The eSubmission Identifier for a NeeS dossier will be in the format “n” followed by 6 digits.
Example, n123456/0000/.
Sequence number
Sequence numbers for eCTD submissions are not applicable for NeeS format dossiers; however, the use of a four digit number in the top level folder name should be followed.
The initial submission should normally have a sequence number of 0000.
As additional data is submitted in response to questions etc, the sequence number of the submission will advance, 0001, 0002, etc.
Only in the case of a technically invalid submission should a sequence be replaced with one using the same number, e.g. the initial sequence “0000” will be replaced by another “0000”.
Any time an electronic submission in the NeeS format is submitted, an updated Lifecycle management tracking table named “tracking.pdf” should be placed in Module 1.0.2. This will support transparency and ease tracking of sequences regardless of the format.
| Sequence | Sequence type | Sequence description | Related sequence |
|---|---|---|---|
| 0000 | Baseline | Reformat | 0000 |
| 0001 | C-Extension of Indication of COPD | Initial | 0001 |
| 0002 | Supplementary information | Response to Request for Information | 0001 |
| 0003 | Supplementary information | Pre-Advisory Committee response | 0001 |
| 0004 | Supplementary information | Product Information | 0001 |
| 0005 | F-Major Variation - New Strength | Initial | 0005 |
Folder and file naming conventions
The top level folder will be part of the submitted NeeS.
For Module 1 dossiers
Follow our recommended folder names.
For Modules 2-5, dossiers
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.
Follow the ICH eCTD folder naming conventions as specified in Appendix 3 of the ICH eCTD Specification (pdf,725kb).
File naming
Follow the eCTD file naming conventions described in the ICH eCTD Specification.
If you are submitting multiple files in one section and there is only one recommended name, you can use a suffix to the filename: using the file name–var.pdf convention, where the –var component have no dashes or illegal characters (for example: pharmaceutical–development–container.pdf).
The number of characters in a folder/file path must not exceed 180 characters.
Counting starts from the first digit of the four digit folder name in which the ctd-toc.pdf is placed.
The maximum length of the name of a single folder or file is 64 characters including the extension.
Legend for Table 10 - Recommended folder names for Module 1
Bold text - Fixed folder name
Normal text - Fixed file name component
Italicised text - Variable file name component
| Content | Correlating AU Module 1 Section |
|---|---|
| nXXXXXX (eSubmission identifer) | |
| 0 | |
| ctd-toc.pdf | |
| m1 | |
| m1-toc.pdf | |
| au | |
| 100-correspondence | 1.0 Correspondence |
| 1001-cover | 1.0.1 Cover letter |
| cover-var.pdf | |
| 1002-tracking | 1.0.2 Lifecycle management tracking table |
| tracking-var.pdf | |
| 1003-response | 1.0.3 Response to request for information |
| response-var.pdf | |
| 102-admin-info | 1.2 Administrative Information |
| 1021-app-form | 1.2.1 Application forms |
| app-form-var.pdf | |
| 1022-pre-sub | 1.2.2 Pre-submission details |
| pre-sub-var.pdf | |
| 1023-patent | 1.2.3 Patent certification |
| pat-cert-var.pdf | |
| 1024-sponsor | 1.2.4 Change in sponsor |
| change-sponsor-var.pdf | |
| 103-med-info | 1.3 Medicine information and labelling |
| 1031-pi | 1.3.1 Product Information and package insert |
| 10311-pi-clean | 1.3.1.1 Product Information - clean |
| pi-clean-var.pdf | |
| 10312-pi-annotated | 1.3.1.2 Product Information - annotated |
| pi-annotated-var.pdf | |
| 10313-pack-ins | 1.3.1.3 Package insert |
| pack-ins-var.pdf | |
| 1032-cmi | 1.3.2 Consumer medicines information |
| 10321-cmi-clean | 1.3.2.1 Consumer medicines information - clean |
| cmi-clean-var.pdf | |
| 10322-cmi-annotated | 1.3.2.2 Consumer medicines information - annotated |
| cmi-annotated-var.pdf | |
| 1033-mockup | 1.3.3 Label mock-ups and specimens |
| mockup-var.pdf | |
| 104-expert | 1.4 Information about the experts |
| 1041-quality | 1.4.1 Quality |
| quality-var.pdf | |
| 1042-nonclinical | 1.4.2 Nonclinical |
| nonclinical-var.pdf | |
| 1043-clinical | 1.4.3 Clinical |
| clinical-var.pdf | |
| 105-specific | 1.5 Specific requirements for different types of applications |
| 1051-lit-based | 1.5.1 Literature-based submission documents |
| lit-based-var.pdf | |
| 1052-orphan | 1.5.2 Orphan drug designation |
| orphan-var.pdf | |
| 1053-gmo | 1.5.3 Genetically modified organisms consents |
| gmo-consents-var.pdf | |
| 1054-add-tradename | 1.5.4 Additional trade name declarations |
| add-tradename-var.pdf | |
| 1055-co-marketed | 1.5.5 Co-marketed medicines declarations |
| co-marketed-var.pdf | |
| 1056-comb-med | 1.5.6 Combination medicine consent |
| comb-med-cons-var.pdf | |
| 1057-otc-prod-assurance | 1.5.7 OTC product assurances |
| otc-prod-assurance-var.pdf | |
| 1058-umbrella-brand-assess | 1.5.8 Umbrella brand assessment |
| umbrella-brand-assess-var.pdf | |
| 106-master-files | 1.6 Master files and certificates of suitability |
| 1061-external-sources | 1.6.1 Relevant external sources |
| external-sources-var.pdf | |
| 1062-app-decl | 1.6.2 Applicant's declaration |
| app-decl-var.pdf | |
| 1063-loa | 1.6.3 Letters of access |
| loa-var.pdf | |
| 107-compliance | 1.7 Compliance with meetings and pre-submission processes |
| 1071-pre-sub-outcomes | 1.7.1 Details of compliance with pre-submission meeting outcomes |
| pre-sub-outcomes-var.pdf | |
| 1072-additional-data | 1.7.2 Details of any additional data to be submitted |
| additional-data-var.pdf | |
| 1073-pre-sub-planning | 1.7.3 Declaration of compliance with pre-submission planning form and planning letter |
| pre-sub-planning-var.pdf | |
| 108-pharmacovigilance | 1.8 Information relating to pharmacovigilance |
| 1081-phvig-system | 1.8.1 Pharmacovigilance systems |
| phvigsystem-var.pdf | |
| 1082-riskmgt-system | 1.8.2 Risk management plan |
| riskmgtsystem-var.pdf | |
| 109-sum-biopharm | 1.9 Summary of biopharmaceutic studies |
| 1091-sum-ba-be | 1.9.1 Summary of bioavailability or bioequivalence study |
| sum-ba-be-var.pdf | |
| 1092-justif-no-study | 1.9.2 Justification for not providing biopharmaceutic studies |
| justif-no-study-var.pdf | |
| 110-paediatrics | 1.10 Information relating to paediatrics |
| paediatrics-var.pdf | |
| 111-foreign | 1.11 Foreign regulatory information |
| 1111-reg-status | 1.11.1 Foreign regulatory status |
| foreign-reg-status-var.pdf | |
| 1112-pi | 1.11.2 Foreign Product Information |
| foreign-pi-var.pdf | |
| 1113-similarities | 1.11.3 Data similarities and differences |
| similarities-var.pdf | |
| 1114-eval-reports | 1.11.4 Foreign evaluation reports |
| eval-reports-var.pdf | |
| 112-antibiotic | 1.12 Antibiotic resistance data |
| antibiotic-var.pdf | |
*Large file warning: Attempting to open large files over the Internet within the browser window may cause problems. It is strongly recommended you download this document to your own computer and open it from there.
The naming of folders in Modules 2 to 5 must follow the format described in Appendix 3: General Considerations for the CTD Modules of the ICH eCTD Specification (pdf,725kb).
Placement of documents
Go to Australian eCTD regional specification and validation criteria 3.0 for guidance on the placement of documents within the CTD structure for particular submission types
Document Table of contents should be located within the document itself. Provide bookmarks for every entry in the document’s Table of Contents to the appropriate location of each document.
If there is no Table of Contents, provide bookmarks to a sufficiently detailed level, typically to Level 3 or 4 headings.
Correspondence
Similar to eCTD, NeeS will support users having a compiled view of the information submitted in the appropriate place in the dossier over time. Therefore, you should also submit formal responses to questions in NeeS format, as well as any correspondence that relates directly to the content of the dossier.
Additional guidance
Module 1.0.3 Responses to requests for information of CTD - Module 1 for additional information.
Moving from NeeS to eCTD format applications
You, as the applicant can switch from NeeS to eCTD at the start of any new regulatory activity.
- Do not change from eCTD back to NeeS.
Additional guidance
AU eCTD Specification section 3.8 - principles concerning change of format.
Footnotes
- A collection of documents and each document is provided as a separate file