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AU NeeS specification: Module 1 and regional information

30 June 2015

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Preparing for your NeeS transaction

Please note: This version (V1.0) of the specification is acceptable until 30 June 2018. Version 2.0 becomes effective on 1 January 2018.

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

  1. Obtain an esubmission identifier
  2. Prepare your cover letter
  3. Validate the NeeS submission
  4. Structure the folder
  5. Select the electronic media
  6. Pack and send the dossier

Obtain an eSubmission Identifier

You will need an eSubmission Identifier before you submit your regulatory activity[1] for an application in the NeeS format.

To obtain an eSubmission Identifier:

  • send an email to esubmissions@tga.gov.au.
  • include the following information in your email:
    • the applicant’s name as listed in the eBS client database
    • name of medicine (the AAN[2] or proposed AANs) or subject of 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.

eSubmission Identifiers when transferring sponsorship

The eSubmission Identifier and the sequences[3] will transfer to the new sponsor when you transfer all the medicines included under an eSubmission Identifier.

We will assign new eSubmission Identifiers to the new sponsor/s if you are only transferring a portion of the medicines included under the same eSubmission Identifier.

Acquiring sponsor

Begin the first sequence of the new application with the next sequence number that would have been submitted under the old eSubmission Identifier (see Table 1 below). This will indicate to evaluators that the medicine was initially reviewed under a different identifier.

Make sure you include the eSubmission Identifier of the previous application in the cover letter of the new application.

Relinquishing sponsor

The further sequences of the medicines that remain under the initial Identifier will continue as usual, however you should mention their removal in the cover letter of your next regulatory activity.

Table 1 - eSubmission Identifiers and transfer of Sponsor activities/tasks
Sponsor FFF Sponsor PPP Sponsor YYY Activity/Task
Product A
Product B
Product C
Product D
n000111Text
     
0001     Application for Products A, B, C and D from Sponsor FFF
0002     A regulatory activity or notification
Product A
Product B
n000111
Product C
Product D
n000222
   
  0003   PPP submits first sequence as 0003 referencing the transfer from n000111 and submitting a regulatory activity.
0003 0004   Companies FFF and PPP undertake business as usual
Product A
Product B
n000111
Product C
n000222
Product D
n000333
 
    0005 YYY submits first sequence as 0005 referencing n000222
0004 0005 0006 Companies FFF, PPP and YYY undertake business as usual

Prepare your cover letter

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

  • The eSubmission 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
    • noncompliance 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[3] and resubmit if there are repeated or excessive issues.

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

We recommend you use one of the validation tools on our website to validate your applications prior to submitting to us.

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.

Related information and guidance

Australian eCTD regional specification and validation criteria 3.0

Structure the folder

Use an application folder named after the eSubmission Identifier and 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.

Pack and send your dossier

Refer to 'How and where to send your dossier' in the general dossier requirements for guidance on how to pack and send your dossier.

We will contact you if we have any issues during the validation and/or uploading a NeeS sequence.


Footnotes

  1. A subgroup of an Application which can be a group of related sequences for one approval or notification process. Usually defined for the lifecycle of the specific approval process
  2. Australian Approved Name
  3. A package of information bundled together in an electronic structure providing information to the agency

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