eCTD Attributes Gulf Cooperation Council
You can use the following attributes to describe eCTD submissions for Gulf Cooperation Council (GCC).
Gulf Cooperation Council-v1.2
| Attribute | Description |
|---|---|
| Agency Name | The name of the receiving agency for the submission. |
| Applicant | The name of the company submitting the eCTD. |
| Application Number | The number issued for the sponsor and the product by the GCC (Gulf Cooperation Council). The Application Number remains from the first data submission for the full lifecycle of the product. Multiple comma-separated values can be provided. |
| ATC | The ATC (Anatomical Therapeutic Chemical) code. Multiple comma-separated values can be provided. |
| Country | The GCC country for which the envelope information is related. |
| INN | The International Nonproprietary Name, used to identify pharmaceutical substances or active pharmaceutical ingredients. Multiple comma-separated values can be provided. |
| Invented Name | The name of the medicinal product. Multiple comma-separated values can be provided. |
| Procedure Type | The procedure type for the product. Available values: gcc, national |
| Related Sequence | The sequence number of a previous submission to which this submission relates. Multiple comma-separated values can be provided. |
| Sequence | The sequence number of the submission. The default is from the Sequence Code, but can be overridden. |
| Submission Description | The description of the Submission to be included in the XML. |
| Submission Type | The filing type of the submission. |
Gulf Cooperation Council-v1.5
| Attribute | Description |
|---|---|
| Agency Name | The name of the receiving agency for the submission. |
| Applicant | The name of the company submitting the eCTD. |
| Application Number | The number issued for the sponsor and the product by the GCC. The Application Number remains from the first data submission for the full lifecycle of the product. Multiple comma-separated values can be provided. |
| ATC | The ATC (Anatomical Therapeutic Chemical) code. Multiple comma-separated values can be provided. |
| Country | The GCC country for which the envelope information is related. |
| INN | The International Nonproprietary Name, used to identify pharmaceutical substances or active pharmaceutical ingredients. Multiple comma-separated values can be provided. |
| Invented Name | The name of the medicinal product. Multiple comma-separated values can be provided. |
| Procedure Type | The procedure type for the product. Available values: gcc, national |
| Related Sequence | The sequence number of a previous submission to which this submission relates. Multiple comma-separated values can be provided. |
| Sequence | The sequence number of the submission. The default is from the Sequence Code, but can be overridden. |
| Submission Description | The description of the Submission to be included in the XML. |
| Submission Type | The filing type of the submission. |
| Submission Unit Type | The actions within the regulatory activity (initial submission, update, responses to questions, any additional information or consolidation submission respectively when closing a regulatory activity). |