Close this search box.
Logo Asphalion

NEW | Majority of Procedures to Move to IRIS Portal in 2024

June 5, 2024

In 2024, the Regulatory Product Management (RPM) for Product Lifecycle Management (PLM) is set to expand its capabilities by supporting key regulatory procedures through the IRIS Portal. The goal is to manage the majority of these procedures, except for Initial Marketing Authorisation and other pre-submission applications, exclusively in IRIS for all Centrally Authorised Products (CAPs) and by extension, for all Marketing Authorisation Holders (MAHs) with CAPs starting in Q4 2024.


Key Procedures Moving to IRIS:

  • Periodic Safety Update Reports (PSURs)
  • Post Authorisation Measures (PAMs)
  • Line Extensions
  • Renewals
  • Annual Reassessments
  • Post-Authorisation Safety Studies (PASS)
  • Referrals


The transition began on January 23, 2024, with the onboarding of variations*, article 61.3 notifications**, and marketing authorisation (MA) transfer procedures for a subset of 67 human and 44 veterinary centrally authorised medicinal products (CAPs). These products were chosen based on their low regulatory complexity.

The selection process for the January rollout involved reviewing the intended submission plans from selected Marketing Authorisation Holders (MAHs), who have already received the final list of products. MAHs who have not been contacted by the European Medicines Agency (EMA) can consider their products not impacted by this initial rollout, and no action is currently required.


Important Notes:

  • Variations not requiring assessment (VNRA) for veterinary use products are to be submitted and managed via UPD but will also be recorded in IRIS to ensure a complete overview of the product lifecycle.
  • ** For human medicinal products.

For more information and to stay updated on these changes, please refer to the upcoming webinars on regulatory procedure management at the bottom of this newsletter.

Stay tuned for further updates as we continue to enhance our regulatory management processes through the IRIS Portal!

Need help? Contact us for your Regulatory requirements at:

Search News & Events

  • Filter by category


Related news and events

CTIS applicable | Faster Access to Clinical Trial Information in Europe

CTIS is the single-entry point for the submission and assessment of clinical trial applications in the EU. It features a public, searchable database aimed at delivering a high level of transparency. The authorisation and oversight of clinical trials are managed by EU/EEA Member States, while the EMA maintains the CTIS. The European Commission oversees the implementation of the Clinical Trials Regulation.

For further information

If you are interested in our services, or wish to get in touch for a general enquiry, please contact us for more information.

Fill the form and we will contact you as soon as possible.

You can also follow us on:

Schedule a Free Meeting

Schedule here a free 30-minutes meeting with one of our consultants and tell us about your project, challenges or doubts. 

We will be happy to assist you!

Schedule a meeting