Module 12 Presentations

Support to the industry: EU Implementation Guides!

Chapters

Topic

Status

Pages

Introduction Legal basis and scope of the EU IG for implementation of ISO IDMP Published*

8

Chapter 1

Registration requirements

Published*

6

Data elements for the electronic submission of information on medicinal products for human use Process for the electronic submission of medicinal product information

Chapter 2

Published*

231

Chapter 3

Published**

34

Chapter 4

Data Quality assurance

Not published

N/A

Chapter 5

Data access/export

Published (soon)*** N/A

Chapter 6

Technical specifications on structure and format

Published*

72

Migration guide: migration rules between xEVMPD and PMS including backward compatibility

Chapter 7

Published*

23

Chapter 8

Practical Examples

Published*

103

Process for submitting existing data on medicinal products authorised for human use (legacy products)

Chapter 9

Published (soon)*** N/A

*published means they are accessible through EMA website but are also still subject to changes/updates **major update expected due to the PLM eAF and its role in the target operating model (TOM) *** Expected mid-Jan 2024 based on earlier EMA communications

The Organisation for Professionals in Regulatory Affairs

Feb 1st, 2024 – TOPRA Module 12