eCTD Attributes South Africa
You can use the following attributes to describe eCTD submissions for South Africa.
South Africa-v1.0
| Attribute | Description |
|---|---|
| Applicant | The name of the applicant/HCR (Holder of Certificate of Registration) submitting the eCTD. |
| Application Number | The number issued for the product by the MCC (Medicines Control Council). The Application Number remains from the first data submission for the full lifecycle of the product. Multiple comma-separated values can be provided. |
| Dosage Form | The dosage form of the medicinal product. Multiple comma-separated values can be provided. |
| Duplicated Applications (Proprietary Names/Dates of Application) | The name of the multiple/duplicate applications of the medicinal product (include, even if the name is not yet approved) plus the application date of the duplicate applications. Multiple paired values can be provided. |
| eCTD Sequence | The sequence number of the data submission. The default is from the Sequence Code, but can be overridden. |
| INN | The INN of the API(s) accompanied by its salt or hydrate form (if relevant) or chemical description of the API(s). Multiple comma-separated values can be provided. |
| Proof of Efficacy | The data type submitted as proof of efficacy, and a description of the data type if "other" is selected as data type. Multiple paired values can be provided. |
| Proprietary Name | The name of the medicinal product. Include even if not yet approved. Multiple comma-separated values can be provided. |
| Related Sequence | The sequence number of a previous submission to which the submission relates. Multiple comma-separated values can be provided. |
| Submission Type | The type of regulatory submission to which the data submission relates. |
South Africa-v2.1
| Attribute | Description |
|---|---|
| Applicant | The name of the applicant/HCR (Holder of Certificate of Registration) submitting the eCTD. |
| Application Number | The number issued for the product by the MCC (Medicines Control Council). The Application Number remains from the first data submission for the full lifecycle of the product. Multiple comma-separated values can be provided. |
| Dosage Form | The dosage form of the medicinal product. Multiple comma-separated values can be provided. |
| Duplicated Applications (Proprietary Names/Application Numbers) | The name of the multiple/duplicate applications of the medicinal product (include, even if the name is not yet approved) plus the application number(s) of the duplicate applications. Multiple paired values can be provided. |
| eCTD Sequence | The sequence number of the data submission. The default is from the Sequence Code, but can be overridden. |
| INN | The INN of the API(s) accompanied by its salt or hydrate form (if relevant) or chemical description of the API(s). Multiple comma-separated values can be provided. |
| Proprietary Name | The name of the medicinal product. Include even if not yet approved. Multiple comma-separated values can be provided. |
| Related Sequence | The sequence number of a previous submission to which the submission relates. Multiple comma-separated values can be provided. |
| Submission Type / Proof of Efficacy | The type of regulatory submission to which the data submission relates followed. The type of regulatory submission is followed by data type submitted as proof of efficacy, and a description of the data type if "other" is selected as data type. Multiple paired values can be provided for the Proof of Efficacy, each bound to the specific submission type. |