Ukraine-v1.0

List of eCTD attributes and their description used for a submission.

Attribute	Description
Country	Unique country code for Ukraine (ua)
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 type of regulatory activity to which the content will be submitted.
Submission Mode	The high-level handling of the information submitted as part of variation(s) and extension applications. The mode should only be used in variation or line extension regulatory activities and must be included in every sequence of that activity.
Submission Unit Type	Submission unit type describes the content at a lower level (a "sub activity") which is submitted in relation to a de³ned regulatory activity.
Submission Number	This number is used by regulatory authority to track the submission, in any procedure, in relation to a particular medicinal product. This is the number of the registration form or package of registration forms.
Applicant	The name of the company submitting the Application.
Agency Name	Regulatory authority which is The State Expert Center of MOH of Ukraine.
Procedure Type	The type of procedure for the submission.
Invented Name	The name of the medicinal product.
INN	International Non-proprietary Name, used to identify pharmaceutical substances or active pharmaceutical ingredients. A non-proprietary name is also known as a generic name.
Sequence	This is the sequence number of the submission - this should start at 0000 for the initial submission, and then increase incrementally with each subsequent submission related to the same medicinal product.
Related Sequence	This is the sequence number of previous submission to which this submission relates e.g. the responses to questions to a particular variation.
Submission Description	This element is used to provide a short text description of the submission.