Marketing Authorization

Type: Information Object

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

Description:
Regulatory approval granted by an authority to market a medicinal product.

Accessed by Application(s):

• Market Access Application
• Regulatory Information Management System

 Yes

Attributes

Order	Name	Description	Type	Cardinality	Example value
1	Authorization ID	Unique identifier for the marketing authorization	GUID	Mandatory
2	Product ID	Reference to the authorized medicinal product	Reference	Mandatory
3	Jurisdiction	Market or jurisdiction where authorization applies	String	Mandatory
4	Indication	Approved treatment indication	String	Mandatory
5	Authorization Holder	Organization holding the authorization	String	Mandatory
6	Approval Date	Date when authorization was granted	Date	Mandatory
7	Renewal Date	Date when authorization renewal is due	Date	Optional
8	Authorization Status	Current status of the authorization	Enumeration	Mandatory

 Yes
 
 Planned
 No PII
 Restricted
 Pharmaceuticals & Life Sciences
 Regulatory approval granted by an authority to market a medicinal product.

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