EMA IRIS Guides updated again

Recommendation

6/7 September 2023
Vienna, Austria

Drug Master File Procedures in the EU, the US and Japan
Taking into account the guidance on metal impurities (ICH Q3D) and genotoxic impurities (ICH M7)

In February and April 2023, the "IRIS guide to registration and RPIs" was updated again and is now valid as version 2.13. Like the "IRIS guide for applicants" and "IRIS guide to parallel distribution applicants", the latest versions of this document are available on the EMA website.

The new features and revisions in the guide are outlined below:
In version 2.12, which was published in February 2023, updates were made to the section "5. Access to IRIS" in addition to formal changes.

In version 2.13, changes have again been made to the following paragraphs and subsections:

• 7.2 Raise an EMA Service Desk request to register a Substance
  
• 8. Requests for a new Research Product Identifier

The respective changes in points 7 and 8 are highlighted in yellow.

In addition, the guide "IRIS guide for applicants" was updated in May 2023 and is now availble in version 2.14. Mainly the revision refers to the subsection 8.2. Signal management submission of section 8. Veterinary Signal Management.

The latest versions of the IRIS documents can be found at:

• IRIS guide to registration and RPIs (Version 2.13)
  
• IRIS guide for applicants (Version 2.14)
  
• IRIS guide to parallel distribution applicants