Regulatory Submission

Type: Information Object

Status: Planned
Industry Sector: Pharmaceuticals & Life Sciences
Sensitivity Level: Restricted
Personal Information: No PII

Description:
Technical, clinical and quality data package submitted to a regulatory authority for product approval.

Accessed by Application(s):

• Regulatory Information Management System

 Yes

Attributes

Order	Name	Description	Type	Cardinality	Example value
1	Submission ID	Unique identifier for the regulatory submission	GUID	Mandatory
2	Product ID	Reference to the medicinal product	Reference	Mandatory
3	Submission Type	Type of regulatory submission	Enumeration	Mandatory
4	Regulatory Authority	Authority receiving the submission	String	Mandatory
5	Jurisdiction	Jurisdiction covered by the submission	String	Mandatory
6	Submission Date	Date when the submission was filed	Date	Mandatory
7	Submission Status	Current review status of the submission	Enumeration	Mandatory
8	Related Authorization	Reference to related marketing authorization where applicable	Reference	Optional

 Yes
 
 Planned
 No PII
 Restricted
 Pharmaceuticals & Life Sciences
 Technical, clinical and quality data package submitted to a regulatory authority for product approval.

✏️ Edit