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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)
   0000  
      ctd-toc.pdf  
      m1  
         m1-toc.pdf  
         Au  
            100-correspondence 1.0 Correspondence
               1001-cover 1.0.1 Cover letter
                  cover-var.pdf  
                  envelope-var.xml* Excel>XML form available on TGA website*
               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-pi-approved* 1.3.1.3 Product information – approved*
                     pi-approved-var.pdf  
                  10314*-pack-ins 1.3.1.4* 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  
                  10323-cmi-approved* 1.3.2.3 Consumer medicines information – approved*
                     cmi-approved-var.pdf  
               1033-mockup 1.3.3 Label mock-ups and specimens
                  mockup-var.pdf  
                  10331-mockup-clean* 1.3.3.1 Label mock-ups and specimens – clean*
                     mockup-clean-var.pdf  
                  10332-mockup-marked-up* 1.3.3.2 Label mock-ups and specimens – annotated*
                     mockup-annotated-var.pdf  
                  10333-mockup-approved* 1.3.3.3 Label mock-ups and specimens – approved*
                     mockup-approved-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-designation* 1.5.2 Designation applications - supporting documents*
                  designation*-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  

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.

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

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

Book pagination