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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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Appendix 2: NeeS envelope items

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

e-Identifier

This is to be assigned –at your request - by the TGA, and used for the name for the NeeS application folder which contains sequence folders.

Example: n123456

eBS Client ID

Enter the applicant's eBS client ID as used in the eBS client database.

Example: 181

Approved name(s)

The approved name(s) of the ingredient(s) - AAN, ABN, etc. as applicable - as they appear in the Australian Approved Names list.

Example: 100604 amoxicillin.

Trade name(s)

The name or proposed medicine (trade) name to be used on the Certificate of Registration.

Example: incrediPill.

For Master Files, insert name of manufacturing site.

ARTG number

ARTG number(s) must be supplied when known, typically for variations to an already registered good. This can be a four-, five- or six-digit number.

Example: 123456

Submission number(s)

The submission number(s) or application number(s) applicable to the sequence being submitted. These should be provided as follows:

  • PM-2017-12345-1-5 Prescription medicines submission numbers: Prefix PM followed by the submission number and stream. If the submission number is not yet known it is appropriate to only include the prefix and the stream i.e., PM-1. NOTE that this will apply whether the activity refers to a biological medicine or other molecular type ('chemical' medicine).
  • BA-2017-12345-1 Biologicals submission numbers: Prefix BA followed by the submission number. If the submission number is not yet known it is appropriate to only include the prefix e.g. BA.
  • OM-2017-12345-1 OTC medicines submission numbers: Prefix OM followed by the submission number. If the submission number is not yet known it is appropriate to only include the prefix e.g. OM.
  • Complementary Medicines: For registered complementary medicines the same protocol applies as for OTC medicines as detailed above. For listed complementary medicines no validation is planned at this time.
  • PV Pharmacovigilance: No submission number is assigned; PV should be entered for all sequences where pharmacovigilance information is submitted.
  • MF Master Files: No submission number is assigned; MF should be entered for all sequences where master file information is submitted.
  • MD Medical Devices: Depending on whether the eCTD application is a device application or a conformity assessment, the prefix should be DA or DC e.g. DA-2017-12345-1.

Allowable combinations of the above are:

  • PM with PV or MF
  • BA with PV or MF
  • OM with PV

Sequence number

The four-digit sequence number matching the sequence folder being submitted.

Example: 0000

Related sequence number

The related sequence number is used to group sequences. This enables us to easily evaluate sequences associated with a particular regulatory activity.

It is particularly helpful when separate regulatory activities for the same medicine are in process at the same time – for example, a new chemical entity registration and one of more variations.

All sequences that belong to a specific regulatory activity should contain the same four-digit number in the related sequence number field as demonstrated in the table below.

Table 11 Relating sequence numbers to the associated regulatory activity
Sequence Related Sequence Sequence Type Sequence Description
0001 0001 New Chemical Entity Initial
0002 0001 Supplementary Information Response to Request for Information
0003 0001 Supplementary Information Response to Request for Information
0004 0004 F - Major Variation - New Dosage Form Initial
0005 0005 Self-Assessment Review (SAR) Initial
0006 0006 G - Minor Variation, New Register Entry - New Container Type Initial
0007 0004 Supplementary Information Response to Request for Information
0008 0004 Supplementary Information Response to Request for Information
0009 0004 Supplementary Information Product Information
0010 0006 Supplementary Information Product Information

Each Initial sequence of a regulatory activity will reference itself.

Each Supplementary Information thereafter will reference the initial sequence of the regulatory activity.

The related sequence number should be approached similar to the Submission ID described in the US regional specification 2.3.

Regulatory activity lead

The regulatory activity lead identifies the group within the TGA which is expected to take the lead in the review process.

Sequence type

The sequence type identifies the type of activity that is being submitted, either:

  • the regulatory activity type (for the first sequence of the regulatory activity)
  • the supplementary information for the follow-up sequences of a regulatory activity that has already commenced.

Sequence description

Content description for the submitted sequence should be one of the values from sequence-description.

Refer to the sequence description for the current list of values.

The examples listed below are a subset of the overall list and show how to handle the different approaches.

  1. You can use some values without further information - for example, Initial.
  2. You will be required to combine some values with a date - for example, Response to Request for Information-2014 03 30.
  3. You enter both the start and end dates for some values - for example, PSUR for Period of 2015-01-01 to 2015-06-30.
  4. You add a brief description (fewer than 40 characters) for other values - for example, Uncategorised, DESCRIPTION.

Submission mode

Until the work grouping and work sharing functions are sufficiently developed for specific guidance to be published, the only valid mode is 'single' which denotes a single regulatory activity.

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