eCTD Attributes Jordan
Jordan-v1.0.2.
| Attribute | Description |
|---|---|
| Country | Country Code |
| Application Reference Number | Element for the reference number of the product as taken from eJDWS. Multiple comma-separated values can be provided. |
| Number | Reference number of the product allocated by the regulatory authority. If the number is not yet allocated at the time point of submission, 'to be advised' should be added instead and replaced by the number in follow-up submissions when registered. |
| UUID | UUID as specified by ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005. The same UUID is used for all sequences of an eCTD Application. UUID is a universal unique identifier.
Using the eCTD wizard, users with appropriate permissions are able to modify the UUID to support Sequences that may require a different UUID than the remainder of the Application. In most cases, the UUID value should not change. |
| Applicant | Name of the company submitting the eCTD. |
| Agency | Name of the receiving agency for the submission. |
| MAH | Marketing Authorisation Holder. |
| ATC | ATC (Anatomical Therapeutic Chemical) code. Multiple comma-separated values can be provided. |
| Submission Type | Filing type of the submission. |
| Submission Unit | Actions within the regulatory activity: initial submission, update, responses to questions, any additional information or consolidation submission respectively when closing a regulatory activity. |
| Procedure | Procedure type for the product. Available values: jo, national. |
| Invented Name | Name of the medicinal product. Multiple comma-separated values can be provided. |
| INN | International Nonproprietary Name, used to identify pharmaceutical substances or active pharmaceutical ingredients. Multiple comma-separated values can be provided. |
| Sequence | Sequence number of the submission. The default is from the Sequence Code, but can be overridden. |
| Related Sequence | Sequence number of a previous submission to which this submission relates. Multiple comma-separated values can be provided. |
| Submission Description | Description of the Submission to be included in the XML. |
Jordan-v1.1.
| Attribute | Description |
|---|---|
| Country | Country Code |
| Application Reference Number | Element for the reference number of the product as taken from eJDWS. Multiple comma-separated values can be provided. |
| Number | Reference number of the product allocated by the regulatory authority. If the number is not yet allocated at the time point of submission, 'to be advised' should be added instead and replaced by the number in follow-up submissions when registered. |
| UUID | UUID as specified by ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005. The same UUID is used for all sequences of an eCTD Application. UUID is a universal unique identifier.
Using the eCTD wizard, users with appropriate permissions are able to modify the UUID to support Sequences that may require a different UUID than the remainder of the Application. In most cases, the UUID value should not change. |
| Applicant | Name of the company submitting the eCTD. |
| Agency | Name of the receiving agency for the submission. |
| MAH | Marketing Authorisation Holder. |
| ATC | ATC (Anatomical Therapeutic Chemical) code. Multiple comma-separated values can be provided. |
| Submission Type | Filing type of the submission. |
| Submission Unit | Actions within the regulatory activity: initial submission, update, responses to questions, any additional information or consolidation submission respectively when closing a regulatory activity. |
| Procedure | Procedure type for the product. Available values: jo, national. |
| Invented Name | Name of the medicinal product. Multiple comma-separated values can be provided. |
| INN | International Nonproprietary Name, used to identify pharmaceutical substances or active pharmaceutical ingredients. Multiple comma-separated values can be provided. |
| Sequence | Sequence number of the submission. The default is from the Sequence Code, but can be overridden. |
| Related Sequence | Sequence number of a previous submission to which this submission relates. Multiple comma-separated values can be provided. |
| Submission Description | Description of the Submission to be included in the XML. |