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 highlevel 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.
Attribute Description
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.

eCTD Attributes Gulf Cooperation Council

You can use the following attributes to describe eCTD submissions for Gulf Cooperation Council (GCC).