Caterina Scarpati

The Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) team is pleased to announce the 1st roll-out of Variations, Article 61.3 Notifications, and Marketing Authorisation Transfers on the IRIS platform today, on 23 January 2024. 
Please note the transition only affects a subset of human (67) and veterinary (44) medicinal products with low regulatory complexity. Impacted Industry and Network stakeholders have already been provided with the final list of products.
This significant achievement follows a meticulous testing phase, including a successful second round of testing in November 2023, building upon initial testing conducted in May and June 2023.
Throughout 2024, the RPM team will concentrate on the incremental delivery of additional system functionalities and the development of additional procedures. In particular, the work will focus on Periodic Safety Update Reports (PSURs), Post-Authorisation Measures (PAMs), Line extensions, Renewals, Annual Reassessments, Post-Authorisation Safety Study (PASS), and Referrals. The roll-out for these procedures on IRIS is scheduled for Q4 2024. More details on 2024-2025 plans can be found in the attached RPM roadmap.
The long-term aim of onboarding end-to-end human and veterinary regulatory procedures on IRIS is to increase automation and efficiency, improve knowledge management and data security, and enhance transparency.
For further information or inquiries about RPM for PLM, please contact iris@ema.europa.eu.

EMA is pleased to announce a new public webinar (event page on EMA website) for medicines developers and regulators eager to gain deeper insights into what the Agency's Product Lifecycle Management (PLM) value stream is working on and its goals.

This webinar aims at illustrating the interconnections between the various digital products being delivered. In addition, further insights into the approach taken to enhance product lifecycle management technology in order enable more efficient and effective medicine regulation will be outlined. 

About PLM: 

PLM is one of three value streams covering the product lifecycle implemented by the Agency as part of its Agile transformation. PLM aims to digitally transform and optimise regulatory procedure management as well as data submission and reuse throughout the product lifecycle. The value stream works with EMA partners and stakeholders to deliver systems and services to manage the authorisation and lifecycle of medicinal products and medical devices within the Agency’s remit for the ultimate benefit of public and animal health in the EU.  

About the Webinar: 

During the webinar, participants will learn more about the value stream’s vision and roadmap towards a data centric target operating model for end-to-end data capture, processing and re-use, as well as how PLM’s products and solutions are contributing to this model.  

Featured PLM Products and Solutions: 

• Solutions for Human & Veterinary medicinal products: 
  • electronic Application Form (eAF) 
  • Regulatory Procedure Management (RPM) on IRIS

 

• Solutions for Human medicinal products: 

  • eCTD v4.0 implementation 
  • Product Management Service (PMS) 
  • Product Data Management User Interface (UI) 
  • electronic Product Information (ePI) 
  • Expert Panels for Medical Devices (EXPAMED)

 

• Solutions for Veterinary medicinal products: 

  • Veterinary Union Product Database (UPD) 

What’s in it for Industry and National Competent Authorities: 

This webinar presents a valuable opportunity for Industry and Network stakeholders to enhance their understanding of the work of the value stream and stay informed about the latest developments in this area, ask questions and interact with the responsible EMA teams. 

Registration & Contact details: 

Interested stakeholders are invited to kindly register at the following link. 

Please note registration will remain open until the start of the webinar.  

You have the opportunity to send your questions in advance via Slido.com using the specific event code: #PLMVS-QA.  

Should you have any questions or require further information, please feel free to contact us at plm.valuestream@ema.europa.eu

EMA is pleased to announce further updates on parallel distribution notification forms in IRIS and changes to the public register for parallel distribution notices.
 

• IRIS submission forms for initial notification, safety update and annual update were updated in section “Documents from Applicant” where applicants are required to indicate the document type (mock-up of outer packaging, mock-up of inner labelling and package leaflet) and the language(s) of these documents.
  For detailed guidance please refer to IRIS user guide for parallel distribution applicants which is updated accordingly.  
   
• Register of Parallel Distribution Notices · IRIS (europa.eu) was updated with addition of re-packager field to allow database search now also by re-packager name. Respectively, re-packager column is also included in the list of search results which allows you to export the details of parallel distribution notices in Excel. 

 
More information is available in the updated IRIS user guide for parallel distributors.

For technical support with submission process or data in the public register, please log a ticket in Service Desk; for general enquiries, please send us a question. or post a new thread in the IRIS Forum “General Discussion and Self-Help”.

Good morning Sara,

We confirm the correct name now is IRIS - eAF Industry User Admin.

EMA's Account Management portal is the gateway to using EMA applications such IRIS, electronic application forms (eAF), EudraVigilance, the Clinical Trials Information System and Union Product Database.

EMA has launched a project to ensure that the registration and access-management process delivers a simple, secure, consistent and user-friendly way for stakeholders to work with EMA.

This webinar is an opportunity for industry and national competent authorities to learn more about access-management aspects and procedures for requesting and managing access to EMA applications. The session will take place on 3 October 2022 via Webex at the following time: 10:30 - 12:30 Amsterdam time (CEST).

If interested to participate, you can register at the following link.

A video recording will be available after the event.

EMA is pleased to announce the launch of the GVP Inspections feature in the IRIS platform. With the implementation of this new feature, Marketing Authorisation Applicants/Holders as well as EU/EEA inspectorates will be able to interact with EMA via a single portal for the exchange of documents and information on GVP Inspections procedures.
This is expected to streamline the Inspection co-ordination process, ensure more secure information exchanges, and increase data quality through integration with other EMA master data systems (e.g. SPOR).

For more information please check the updated IRIS guide for applicants and the Guidance for applicants/MAHs involved in GMP, GCP and GVP inspections co-ordinated by EMA.

Kindly note a recording from the training session on GVP for Industry users will be made available from the IRIS portal section “Additional guidance & training videos”.

If you have general questions with regard to the IRIS feature on GVP Inspections, please post a new thread in the IRIS Forum “General Discussion and Self-Help”. If you have technical questions or issues please raise a ticket via the new EMA ServiceNow system.
 

Yes, a person with "Industry manager" role can nominate himself/herself for MAH i-SPOC (only consideration is that the user should be affiliated in IAM).
 

For this kind of technical issue, you should submit your request to the EMA Service Desk by using the EMA Service Desk Portal.