Module 12 2019

Benefits of structured data – Current process for an administrative change

Change of the name of the Manufacturer

Company name Munnik Pharma - ORG ID 1234

Company name Remco Farma - ORG ID 1234

Company submits message to EMA that O data is changed, including proof (chamber of commerce document / revised manufacturing license)

Organisation name in O (SPOR) is updated and an automatic workflow is initiated to inform involved companies and authorities

EMA verifies change

EMA approves changes in O

Updated documentation is uploaded in EUDRAGMDP

MAH 2

MAH 1

MAH 3

MAH 4

MAH 5

NCA 1

NCA 2

NCA 3

NCA 5

NCA 4

• Increased compliance → all MAHs/NCAs are informed about the change at the same moment in time • Quicker implementation → change is implemented immediately, do and tell • Reduction of effort for all stakeholders → no need for any further notification or administrative activities

The Organisation for Professionals in Regulatory Affairs