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NeeS AU module 1 and regional information

Specification and guidance for use, V2.0

18 October 2017

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Structure and naming requirements

Please note: V1.0 of the specification is acceptable until 30 June 2018. This version (V2.0) becomes effective on 1 January 2018.

Folder and file structure

The structure of a NeeS format dossier must conform to both:

Name the root folder of the dossier with the e Identifier of the medicine followed by the subfolder name (sequence number) of four digits.

The e-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 also be followed for the NeeS format.

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.

Table 9 Example of a Lifecycle management tracking table
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 the Australian recommended folder names.

For Modules 2-5, dossiers

How to access a pdf document

*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,726kb).

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

Parts of the table below are shaded in yellow and include an asterisk*; this indicates changes that have been made between the NeeS versions 1.0 and 2.0.

Table 10 Recommended folder names for Module 1
Content Correlating AU Module 1 Section
nXXXXXX (e-Identifier)
            100-correspondence 1.0 Correspondence
               1001-cover 1.0.1 Cover letter
                  envelope-var.xml* Excel>XML form available on TGA website*
               1002-tracking 1.0.2 Lifecycle management tracking table
               1003-response 1.0.3 Response to request for information
            102-admin-info 1.2 Administrative Information
               1021-app-form 1.2.1 Application forms
               1022-pre-sub 1.2.2 Pre-submission details
               1023-patent 1.2.3 Patent certification
               1024-sponsor 1.2.4 Change in sponsor
            103-med-info 1.3 Medicine information and labelling
               1031-pi 1.3.1 Product information and package insert
                  10311-pi-clean Product information - clean
                  10312-pi-annotated Product information - annotated
                  10313-pi-approved* Product information – approved*
                  10314*-pack-ins* Package insert
               1032-cmi 1.3.2 Consumer medicines information
                  10321-cmi-clean Consumer medicines information - clean
                  10322-cmi-annotated Consumer medicines information - annotated
                  10323-cmi-approved* Consumer medicines information – approved*
               1033-mockup 1.3.3 Label mock-ups and specimens
                  10331-mockup-clean* Label mock-ups and specimens – clean*
                  10332-mockup-marked-up* Label mock-ups and specimens – annotated*
                  10333-mockup-approved* Label mock-ups and specimens – approved*
            104-expert 1.4 Information about the experts
               1041-quality 1.4.1 Quality
               1042-nonclinical 1.4.2 Nonclinical
               1043-clinical 1.4.3 Clinical
            105-specific 1.5 Specific requirements for different types of applications
               1051-lit-based 1.5.1 Literature-based submission documents
               1052-designation* 1.5.2 Designation applications - supporting documents*
               1053-gmo 1.5.3 Genetically modified organisms consents
               1054-add-tradename 1.5.4 Additional trade name declarations
               1055-co-marketed 1.5.5 Co-marketed medicines declarations
               1056-comb-med 1.5.6 Combination medicine consent
               1057-otc-prod-assurance 1.5.7 OTC product assurances
               1058-umbrella-brand-assess 1.5.8 Umbrella brand assessment
            106-master-files 1.6 Master files and certificates of suitability
               1061-external-sources 1.6.1 Relevant external sources
               1062-app-decl 1.6.2 Applicant's declaration
               1063-loa 1.6.3 Letters of access
            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
               1072-additional-data 1.7.2 Details of any additional data to be submitted
               1073-pre-sub-planning 1.7.3 Declaration of compliance with pre-submission planning form and planning letter
            108-pharmacovigilance 1.8 Information relating to pharmacovigilance
               1081-phvig-system 1.8.1 Pharmacovigilance systems
               1082-riskmgt-system 1.8.2 Risk management plan
            109-sum-biopharm 1.9 Summary of biopharmaceutic studies
               1091-sum-ba-be 1.9.1 Summary of bioavailability or bioequivalence study
               1092-justif-no-study 1.9.2 Justification for not providing biopharmaceutic studies
            110-paediatrics 1.10 Information relating to paediatrics
            111-foreign 1.11 Foreign regulatory information
               1111-reg-status 1.11.1 Foreign regulatory status
               1112-pi 1.11.2 Foreign product information
               1113-similarities 1.11.3 Data similarities and differences
               1114-eval-reports 1.11.4 Foreign evaluation reports
            112-antibiotic 1.12 Antibiotic resistance data

How to access a pdf document

*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,726kb).

Placement of documents

Go to Australian regional specification and validation criteria 3.1 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.


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

See the section on 'baseline sequences' in the eCTD AU module 1 and regional information 3.1.

Book pagination