EMA: Update of the "IRIS Guidance Documents"

Recommendation

28-30 March 2023

Global Registration and Life Cycle Management of APIs - Live Online Training
Contents of the regulatory information in the ASMF and CEP

Both the "IRIS guide to registration and RPIs" and the "IRIS guide for applicants" were updated in February and published on the EMA website. The two documents are intended to provide guidance on the use of the IRIS platform and contain practical advice for applicants.

IRIS guide to registration and RPIs

The "IRIS guide to registration and RPIs" is now valid in its version 2.8. It describes the registration process for the online platform IRIS in detail and presents it step by step. In addition to the list of abbreviations and their explanations, the document contains eight chapters, listed as follows:

• 1. Purpose and Context
• 2. Working out what steps are required for you
• 3. EMA Account Management
• 4. Organisation registration in OMS (SPOR)
• 5. Access to IRIS
• 6. How to access IRIS after your role has been approved
• 7. How to register a new active Substance in SMS
• 8. How to create a request for a Research Product Identifier

Chapters 1, 4, 5, 7 and 8 each contain subsections and detailed explanations of the respective questions.

IRIS guide for applicants

The "IRIS guide for applicants" is now valid in its version 2.6. and is subtitled "How to create and submit scientific applications, for industry and individual applicants". It should be seen as guidance for submitting applications using the IRIS platform and provides supporting information on how to present various procedures in IRIS, such as Scientific Advice and GMP/GCP inspections. In addition to the list of abbreviations and their explanations, this document also contains eight chapters, listed as follows:

• 1. Purpose and context
• 2. Common operations for all scientific submission types
• 3. Orphan submissions
• 4. Scientific Advice
• 5. ITF Briefing Meeting Requests
• 6. Marketing Status
• 7. Inspections
• 8. Veterinary Signal Management

Chapters 1, 2, 3, 4, 6, 7 and 8 each contain subsections with detailed explanations and screenshots on the respective topics and issues.

The new versions of the IRIS guides can be found here:

• IRIS guide to registration and RPIs
• IRIS guide for applicants