Australia-v3.1
| Attribute | Description |
| Approved Name(s) | The name of the active ingredients that are accepted for inclusion in the Australian Approved Name list. You can enter up to 500 characters. Multiple comma-separated values can be provided. |
| ARTG Number(s) | The Australian Register of Therapeutic Goods number. The ARTG can be a four, five, or six digit number. Multiple comma-separated values can be provided. |
| Contact Email | Results of the sequence validation are sent to the email addresses provided. You can enter up to 500 characters. Multiple comma-separated values can be provided. |
| e-Identifier |
The Application Number as provided by the agency. The value must be a lowercase letter followed by six digits. Example: a123456 |
| Attribute | Description |
| eBS Client ID | The client ID as listed in the eBS client database. You can enter up to 200 characters. |
|
Regulatory Activity Lead |
Identifies the group within the TGA that is expected to take the lead in the review process. |
|
Related Sequence Number |
Four-digit sequence number used for supplementary information indicating the initial sequence number of the regulatory activity. |
| Sequence Description | Content description for the submitted sequence. |
| Sequence Number | Four-digit sequence number matching the sequence folder being submitted. |
| Sequence Type | Identifies the type of activity that is being submitted with the sequence, either the regulatory activity type if it is the first sequence of the regulatory activity or supplementary information if it is a follow-up to information already submitted for the regulatory activity. |
|
Submission or Application Number(s) |
The submission number(s) or application number(s) applicable to the sequence being submitted. You can enter up to 500 characters. Multiple commaseparated values can be provided. |
| Submission Mode | The value can be set to Single, Work-grouping, or Work-sharing. Until the work grouping and work sharing functions are sufficiently developed, the only valid mode is Single which denotes a single regulatory activity. |
| Trade Name(s) | The name or proposed product (trade) name to be used on the Certificate of Registration. You can enter up to 500 characters. Multiple comma-separated values can be provided. |
The following table describes are recommendation for providing the Submission Number values:
| Submission Number Value | Description | Allowable Combinations |
| 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. Example: PM-1 Note: This will apply whether the activity refers to a biological medicine or other molecular type ('chemical' medicine). |
— PM with PV or MF — BA with PV or MF — OM with PV — PV with PM, BA, or OM — MF with PM or BA |
| 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. Example: 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. Example: 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 | ||
| ©Ennov 2024 Ennov |
prefix should be DA or DC.278 Example: DA-2017-12345-1. |
Ennov InSight Publisher 7.3 Create eCTD Wizard |
eCTD Attributes Canada
You can use the following attributes to describe eCTD submissions for Canada.