eCTD Attributes European Union
European Union-v3.1
| Attribute | Description |
|---|---|
| Country | Defines which country the envelope information is related to. |
| UUID | A UUID as specified by ISO/IEC 11578:1996 and ITU-T Rec X.667 | ISO/IEC 9834-8:2005. The same UUID must be used for all sequences of an eCTD application. |
| Submission Type | The Filing type of the submission. |
| Submission Mode | The mode of the submission, either single, grouping, or worksharing. |
| Submission Unit Type | Submission unit type describes the content at a lower level (a "sub-activity") which is submitted in relation to a defined regulatory activity. |
| High Level/Worksharing Submission Number | The high level submission number for the specific submission, used when the submission mode is grouping or worksharing. |
| Application Tracking Number | The Application Number as provided by the agency. |
| Applicant | The name of the company submitting the application. |
| Agency Name | The name of the agency that the submission is being sent to. |
| Procedure Type | The procedure type being used to submit. |
| Invented Name | The invented name of the product being submitted for approval. |
| INN | The INN of the product being submitted for approval. |
| Sequence | The Sequence Number for this submission. |
| Related Sequence | This is the sequence number of previous submission(s) to which this submission relates. For example, the responses to questions to a particular variation. In the case of submission unit types 'initial' and 'reformat' related sequence is identical to the sequence number. |
| Submission Description | The description of the Submission to be included in the XML. |
European Union-v3.0.1
| Attribute | Description |
|---|---|
| Agency Name | The name of the receiving agency for the submission. The default is based on the country for the application. |
| Applicant | The name of the company submitting the eCTD. |
| Application Tracking Number | The number used by an agency or applicant to track the submission, in any procedure, in relation to a particular product. There must be at least one tracking number identified from the regulators. The applicant can choose to include an internal tracking number. |
| Country | The country to which the envelope applies. The default is the country of the application. |
| High Level/Worksharing Submission Number | The high-level submission number, either a 'worksharing' number or the high-level submission number to be used when grouping Type IA variations for multiple marketing authorisations. It is used when the submission mode is either Grouping or Worksharing. |
| INN | International Nonproprietary Name, used to identify pharmaceutical substances or active pharmaceutical ingredients. |
| Invented Name | The invented name of the medicinal product which is submitting for an approval. |
| Procedure Type | The type of procedure for the submission. The default is based on the application Country. |
| Related Sequence | The sequence number(s) of previous submission(s) to which this submission relates. |
| Sequence | The sequence number of the submission. |
| Submission Description | The description of the submission to be included in the XML. |
| Submission Mode | The mode of the submission, either Single, Grouping, or Worksharing. The submission mode should only be used in variation or line extension regulatory activities and must be included in every sequence of that activity. |
| Submission Type | The type of submission material sent to the regulatory agency. |
| Submission Unit Type | Submission unit type describes the content at a lower level (a “sub-activity”) which is submitted in relation to a defined regulatory activity. |
| UUID | A 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 applications. UUID is a universal unique identifier.
Through 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. |
European Union-v3.0
| Attribute | Description |
|---|---|
| Agency Name | The name of the receiving agency for the submission. The default is based on the country for the application. |
| Applicant | The name of the company submitting the eCTD. |
| Application Tracking Number | The number used by an agency or applicant to track the submission, in any procedure, in relation to a particular product. There must be at least one tracking number identified from the regulators. The applicant can choose to include an internal tracking number. |
| Country | The country to which the envelope applies (or 'ema'). The default is the country of the application. |
| High Level/Worksharing Submission Number | The high-level submission number, either a 'worksharing' number or the high-level submission number to be used when grouping Type IA variations for multiple marketing authorisations. It is used when the submission mode is either Grouping or Worksharing. |
| INN | International Nonproprietary Name, used to identify pharmaceutical substances or active pharmaceutical ingredients. |
| Invented Name | The name of the medicinal product. |
| Procedure Type | The type of procedure for the submission. The default is based on the application Country. |
| Related Sequence | The sequence number(s) of previous submission(s) to which this submission relates. |
| Sequence | The sequence number of the submission. |
| Submission Description | The description of the submission to be included in the XML. |
| Submission Mode | The mode of the submission, either Single, Grouping, or Worksharing. The submission mode should only be used in variation or line extension regulatory activities and must be included in every sequence of that activity. |
| Submission Type | The type of submission material sent to the regulatory agency. |
| Submission Unit Type | Submission unit type describes the content at a lower level (a “sub-activity”) which is submitted in relation to a defined regulatory activity. |
| UUID | A 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 applications. UUID is a universal unique identifier.
Through 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. |
European Union-v2.0
| Attribute | Description |
|---|---|
| Agency Name | The name of the receiving agency for the submission. The default is based on the country for the application. |
| Applicant | The name of the company submitting the eCTD. |
| Application Tracking Number | The number used by an agency or applicant to track the submission, in any procedure, in relation to a particular product. There must be at least one tracking number identified from the regulators. The applicant can choose to include an internal tracking number. Multiple comma-separated values can be provided |
| Country | The country to which the envelope applies (or 'ema'). The default is the country of the application. |
| High Level/Worksharing Submission Number | The high-level submission number, either a 'worksharing' number or the high-level submission number to be used when grouping Type IA variations for multiple marketing authorisations. It is used when the submission mode is either Grouping or Worksharing. |
| INN | 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 type of procedure for the submission. The default is based on the application Country. |
| Related Sequence | The sequence number(s) of previous submission(s) to which this submission relates. Multiple comma-separated values can be provided. |
| Sequence | The sequence number of the submission. |
| Submission Description | The description of the submission to be included in the XML. |
| Submission Mode | The mode of the submission, either Single, Grouping, or Worksharing. The submission mode should only be used in variation or line extension regulatory activities and must be included in every sequence of that activity. |
| Submission Type | The type of submission material sent to the regulatory agency. |