Caterina Scarpati

The EMA is pleased to announce a series of webinars for SPOR and XEVMPD scheduled from 04 to 14 October 2024.
EMA SPOR Regulatory Data Management services aim to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, enabling increased data quality and interoperability, efficiencies and more efficient regulatory action. Through the integration of its services with other systems used for regulatory procedures, such as IRIS, SPOR actively contributes to their success and create benefits for users.
The presentations (including agendas) will be shared before the start of the webinars.
The sessions will cover practical information for users, including, for each SPOR service:

• General principles and rules;
• Key processes;
• Key performance and data quality metrics;
• Updates & next steps.

The webinars will be conducted via Webex, and participants can join using the link provided on the event web page on the day of the event, with no need to register. Participants can join on a first-come, first-served basis until the session reaches its capacity of one thousand attendees.
 

Webinar title & event web page link	Date	Time	Slido code
SPOR Data  Governance	4 October 2024	10:00 - 12:00 (CEST)	#SWOCT424
Referentials Management Service (RMS)	7 October 2024	10:00 - 12:00 (CEST)	#SWOCT724
Substance Management Service (SMS)	8 October 2024	10:00 - 12:00 (CEST)	#SWOCT824
Organisation Management Service (OMS)	9 October 2024	10:00 - 12:00 (CEST)	#SWOCT924
Product Management Service (XEVMPD)​ for MAHs	10 October 2024	10:00 - 12:00 (CEST)	#SWOCT1024
Product Management Service (XEVMPD)​ for Sponsors	11 October 2024	10:00 - 12:00 (CEST)	#SWOCT1124
SPOR Application Programming Interface	14 October 2024	10:00 - 12:00 (CEST)	#SWOCT1424

Feel free to submit questions in advance via Slido.com using the dedicated Slido code indicated above for each session.

Please note that in most cases (for cases with a single product) the submission number is the same as the case number. 
Hope this clarifies.

The case title replaces the variation number in IRIS for all procedure types. This number is available in the case submission details and also in the procedure documents.
Hope this clarifies.

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

New functionalities have been introduced in EMA Account Management 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.

Date: 20 September 2024
Time: 10:00 - 11:00 (CEST)
Webex link to join: link
Event web page: link
Slido: feel free to submit questions in advance via the dedicated Slido (event code: 7217702). The organisers will do their best to incorporate the questions in the upcoming presentations.

Video recording will be available on the event web page.
Registration is not required. Participants may join on a first-come, first-served basis and will not be able to join when session capacity reaches one thousand attendees.

We directly contacted the MAHs whose CAPs have already been migrated to IRIS.
The products from other MAHs should be migrated when the transition of all post-authorisation procedures takes place on IRIS, i.e. 1 January 2025.
 

Please find attached a brief transition overview presentation including: 

• the detailed roadmap for post-authorisation procedures transition to IRIS; 

• key changes for Industry users & what stays the same; 

• general process flow for regulatory procedures in IRIS; 

• summary of key actions & engagement activities for Industry users this year. 

Important: Submission of all regulatory procedures of the product lifecycle will still be performed via the current systems (i.e. Gateway and PSUR repository) 

As part of the transition, we require all Marketing Authorisation Holders (MAHs) product contact points to register in the EMA Account Management System by 31 October 2024. This is essential to ensure seamless email communication, access to case information, and document management. 

Important instructions for you: 

1. Use of personal mailboxes as product contacts: 

• Due to security reasons, IRIS will no longer accept generic mailboxes as contact points for regulatory procedure application submissions. 
• If your products currently list generic mailboxes, please update all product contacts to personal mailboxes associated with responsible individuals within your organisation: 
  a. Submit the updated form using the following template: template_letter-change_contact_person_en.doc (live.com). 
  b. Instructions to submit the form are available here: 
      - Human-use products: Contacting EMA: post-authorisation | European Medicines Agency (europa.eu)
      - Veterinary-use products: Notifying EMA of changes to contact persons (veterinary medicines) | European Medicines Agency (europa.eu) 

1. Register all contacts in EMA Account Management System (IAM) by 31 October 2024 (or as soon as possible if your products are already transitioned to IRIS): 

• Request access via the EMA Account Management System for all affiliated roles. Detailed instructions are available in the IRIS guide to registration and RPIs. 
• Ensure the access is requested for the relevant organisations affiliated with the products you are contact for (Request Access · EMA Account Management (europa.eu)). 

If you have already an IRIS Account that complies with the above guidelines, please ignore this request.

Transition overview: 

• The first transition of Regulatory Procedure Management (RPM) for Product Lifecycle Management (PLM) to IRIS took place on 23 January 2024, onboarding variations*, Article 61.3 notifications**, and marketing authorisation (MA) transfer procedures for a subset of 67 human and 45 veterinary centrally authorised medicinal products (CAPs) with low regulatory complexity. 

• A second transition took place in July 2024: 37 human and 16 veterinary products were migrated to IRIS for the procedures listed above. 

• In 2024, we continue developing further regulatory procedures in IRIS: Periodic Safety Update Reports, Post-Authorisation Measures, Line Extensions, Renewals, Annual Reassessments, Post-Authorisation Safety Studies, and Referrals. These procedures will transition to IRIS for all CAPs (and, consequently, for all MAHs with CAPs) in January 2025. 

Further information

If you would like to stay up to date on planned RPM engagement activities, we encourage you to subscribe to the quarterly Product Lifecycle Management (PLM) Newsletter. 

We also encourage you to fill in this survey after you have reviewed the information in this email and presentation to share your awareness and readiness for the 2025 IRIS transition.

The EMA is pleased to announce a public webinar on Substance, Product, Organisation, Referentials (SPOR) Data Management services update scheduled on 10 July 2024 (10:00 – 12:30 CEST).
SPOR services aim to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, enabling increased data quality and interoperability, efficiencies, and more efficient regulatory action. Through the integration of its services with other systems used for regulatory procedures, such as IRIS, SPOR actively contributes to their success and full benefits realisation.
During the event, the following information on the SPOR data management services (i.e. SMS, XEVMPD/Art.57, OMS, and RMS) will be provided:

• achievements in Q2 2024
• what is planned for Q3 2024
• what are the key highlights for SPOR users

Please save the date for this important event.
The session will be broadcasted live on the EMA YouTube Channel.
The broadcast link, agenda and presentation will be available on the event web page.
Note that this session will not include updates on the Product Management Service (PMS), as separate sessions for PMS are planned.
 

As of 1^st July 2024 notifications of safety update for products distributed in parallel will not be required and will be removed from the list of submission types in IRIS.
The obligation to implement safety-related changes in the product information within three months of publication of the updated annexes to the marketing authorisation, and within six months for non-safety-related changes, will continue to rest with parallel distributors.
Parallel distributors are advised to sign up for automated notifications (RSS feed) by clicking on “RSS” icon in the right corner of the product banner next to the authorisation status icon on European public assessment report (EPAR) page, in order to be timely notified about the published changes of the product information.

For more details, please refer to the revised procedural guidance documents:
Frequently asked questions about parallel distribution | European Medicines Agency (europa.eu)
Parallel distribution: Regulatory and procedural guidance | European Medicines Agency (europa.eu)
 

EMA launched the Product Lifecycle Management Insights Newsletter to help medicines developers stay up to date on news and actions related to the development of digital capabilities related to Product Lifecycle Management (PLM). In particular, the management of the authorisation and lifecycle of medicines as well as medicinal product data. 

Subscribe to the Product Lifecycle Management Insights Newsletter & access the first PLM Insights Newsletter publication here.

About PLM:  

Product Lifecycle Management (PLM) is one of three value streams in EMA’s Network Portfolio covering the digital capabilities to support the product lifecycle implemented by the Agency. 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 for the ultimate benefit of public and animal health in the EU. 

PLM encompasses development of capabilities related to among others PMS data, UPD, electronic applications forms (eAF), electronic Product information (ePI), regulatory procedure management (RPM for IRIS). 

What you will get: 

• Quarterly updates in your inbox with the most important new information and announcements.  
• Reminders of actions and opportunities related to PLM tools and systems. 
• Links through to more details and useful resources to support you in your preparation and adoption of new tools and systems. 

How to subscribe: Subscribe to the Product Lifecycle Management Insights.  

The EMA is pleased to announce a public event aiming to provide a comprehensive understanding of Product Management Service (PMS), its use cases in EMA digital services and actions Industry & Network stakeholders should start preparing to take. The info-day will take place on 16 April 2024 (9:15 – 17:30 CEST).
The event will:

• highlight PMS’s enabling role in digital solutions in EMA portfolio such as electronic application forms (eAF), regulatory procedure management (IRIS), electronic product information (ePI) and the future European Shortages Monitoring Platform (ESMP);
• provide an overview of PMS plans – including latest developments, as the go-live of PMS Application Programming Interface (Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs), read-only) and Product User Interface (CAPs, read-only), both planned for Q2 2024;
• demonstrate how Substances, Organisations and Referentials (SOR) and XEVMPD services come together to support PMS;
• showcase current practices for both Industry and National Competent Authorities in relation to preparing for PMS data readiness.

This event is highly advised to attend for PMS for those responsible for regulatory data management in their organisations.
Please save the date for this important event.
The session will be broadcasted live on the EMA YouTube Channel.
The broadcast link, agenda and presentation will be available on the event web page.