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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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Preparing for your NeeS transaction

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

Before you submit your regulatory activity in NeeS format, you will need to:

  1. Obtain an e-Identifier
  2. Complete the NeeS Envelope Form
  3. Prepare your cover letter
  4. Validate the NeeS submission
  5. Structure the folder
  6. Select the electronic media
  7. Pack and send the dossier

Obtain an e-Identifier

You will need an e-Identifier before you submit your regulatory activity for an application in the NeeS format.

To obtain an e- Identifier:

  • send an email to esubmissions@health.gov.au.
  • include the following information in your email:
    • the applicant's name as listed in the eBS client database
    • name of active ingredient (the AAN, ABN as applicable; or proposed name) or subject of a NeeS sequence regarding a Master File
    • a description of the Application (application type, dosage form), if referring to a medicine
    • name and address of manufacturing site, if referring to a Master File.

The identifier is:

  • made up of a letter and six digits. Example: n123456 ('n' indicates the identifier refers to a NeeS application)
  • valid throughout the entire lifecycle of a product unless the product is split from a package as explained elsewhere.

Complete the NeeS Envelope Form

Complete the NeeS Envelope Form as detailed in Appendix 1: The AU NeeS envelope form – guidance.

Place the resulting envelope.xml file in the 1001-cover folder of your NeeS application.

Prepare your cover letter

Include the following information in the cover letter in addition to the CTD requirements for the Cover Letter:

  • The e-Identifier, the sequence and related sequence in the subject line.
  • A description of the eSubmission:
    • type and number of electronic media
    • approximate submission size
    • any characteristics concerning the media that we might need to know.
  • A description of the software used to check the files for viruses and a statement as to whether the submission is virus free.
  • The regulatory and information technology points of contact for the submission.
  • Information about the validation including:
    • the validation tool and version used
    • any findings e.g. errors, warnings or possible missing documents as designated by the eSubmission Document Matrix that would be expected for your specific sequence type.
  • Include a paper copy of the Cover Letter with the physical media containing the NeeS sequence. This is only necessary until we develop an electronic portal.

You do not need to include a copy of the validation report; however an electronic copy of the report needs to be provided if requested.

Validate the NeeS submission

There are two types of NeeS validation findings:

  • Pass/Fail – Critical finding:
    • validation findings categorised as 'Pass/Fail' must be addressed
    • non-compliance will lead to rejection of the sequence.
  • Best Practice – Best practice recommendations:
    • You should address validation findings categorised as 'Best practice'.
    • We recommend you eliminate best practice recommendations whenever possible.
    • We may request you to fix the sequence and resubmit if there are repeated or excessive issues.

Please minimise sequences with best practice recommendations and address any findings in the Cover Letter.

You must validate your sequence prior to submitting to us. The validation software that you use should be able to validate the AU Module 1 criteria. We also validate each eCTD sequence using the AU Validation Criteria.

Sequences with errors or deficiencies

We will reject sequences with critical validation findings and you will need to re-submit unless you gain our agreement.

If your sequence has content deficiencies, you will need to submit changes in a follow-up sequence.

Structure the folder

Use an application folder named after the e-Identifier. Include in this application folder the sequence folder(s) as sub-folder(s) with their contents.

Example: D:\n123456\0001

Select the electronic media

The size of an eSubmission is only limited by the size of your media format.

Refer to 'Electronic media delivery' in the general dossier requirements for guidance on the types of electronic media you can use for a NeeS sequence to submit as one unit.

Sending your NeeS dossier

If your sequence is less than 100Mb and you have it ready by the time you complete the online pre-submission application form, you can upload it as a zip file directly into the form.

OR

If the file size is small enough to attach to an email, do so and email it to esubmissions@tga.gov.au.

OTHERWISE

Follow the guidance in Part B of general Dossier requirements located at General dossier requirements: Part B: Electronic dossiers.

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