Product Lifecycle Management Insights

EMA introduced e-mail address authentication for EMA applications to improve the security and usability of EMA applications in 2023. E-mail address authentication eliminates the need for users to remember their EMA username and password while allowing better access control. EMA shared details of what is changing in September 2024.

The transition to e-mail address authentication started on the basis of voluntary opt-in in December 2023. In September 2024 EMA shared its plan to complete the transition. As part of the plan, EMA has started to pro-actively convert users who have not yet opted in to email address authentication as of 20 January 2025.

The opt-in process has the benefit of allowing users to verify their e-mail, so EMA recommends opting in before the conversion deadlines below:

• 20th of January: Non regulatory users without specific application roles.
• 3rd of February: Non regulatory users with application roles.
• 3rd of March: Regulatory users (European medicines regulatory network).
• 31 of March: all users are converted.

Note that anyone that created an EMA account after September 2024 already did so using email address authentication. Nothing will change for these users as they are already using the updated setup.

How to opt-in
Users can opt-in to email authentication in EMA Account Management by following the enclosed detailed instructions. 

Once converted to email authentication, users can use their email address to authenticate themselves when accessing EMA systems. As part of logging in, users will either be redirected to their authentication page or will receive an email with an authentication code. 

System Demo (12 December 2024):  

• System Demo recording (Timestamp: 11:25 eAF), highlighting the latest developments in eAF functionalities.

User guides:

• Updated PLM Portal (eAF) Guide to Registration to support users of the PLM Portal - eAF in completing the registration steps before accessing the platform.
• Guide for PLM Portal eAF navigation (web eAF user guide) to support users of the PLM Portal - eAF in navigating through the platform and preparing application forms.

Frequently Asked Questions:

• eAF and PMS Frequently Asked Questions (FAQs) on PLM Portal Identity and Access Management, navigation and general aspects.
• eAF and PMS Joint Questions and Answers (Q&A) on objectives, scope, expected benefits and impacted stakeholders linked to eAF and PMS implementation.

Trainings & additional resources:

• Information Session on FHIR for PLM Portal web-based electronic Application Form (eAF) for NCAS, providing a comprehensive overview of the FHIR XML integrated into the web-based eAF, detailing the operational processes at the EMA.
• eAF – FHIR XML – Release Notes 

ePI on the EMA website:

• Electronic product information (ePI) | European Medicines Agency (europa.eu)

System Demo (12 December 2024):

• System Demo recording (Timestamp: 10:15 ePI). showing the latest ePI developments and functionalities.

User guides:

• ePI User Guide for applicants to access ePI User Guides

Frequently Asked Questions:

• ePI Frequently Asked Questions (FAQ) Document to get more information on what the ePI is, its key principles, and details about the ongoing ePI pilot.

PMS on the EMA website:

• Substance and product data management services | European Medicines Agency (EMA)

System Demo (12 December 2024):  

• System Demo recording (Timestamp: 09:25 PMS) showing the latest PMS developments and functionalities.

PMS PUI guidance documents:

• PMS Product UI registration guide: support in completing the steps needed to gain access to the PUI.
• PMS Product UI navigation guide: support in navigating across the pages of the PUI.
• PMS Product UI known issues document: details of all known issues in the PUI and workarounds where available.

Recordings, presentations, Q&A Documents from events:

• Webinar on submission of Manufacturers, Manufacturing Business Operations (MBOs) and structured pack size data to Product Management Service (PMS) (25 November 2024): explain how manufacturers and manufacturing business operations should be submitted to the PMS PUI to support the European Shortages Monitoring Platform (ESMP), providing an overview of the entire process.
• Informative webinar on PMS Product User Interface usage and key actions for Marketing Authorisation Holders (with demo) (29 October 2024): showcase the PMS PUI, recap current & future key actions for Marketing Authorisation Holders and answer users’ questions.
• PMS API Training session (8 July 2024) providing a thorough explanation on access and data read for the PMS API, including a comprehensive demo.

Frequently Asked Questions:

• PMS Frequently Asked Questions Document
• eAF and PMS Frequently Asked Questions (FAQs) on PLM Portal Identity and Access Management, navigation and general aspects.
• eAF and PMS Joint Questions and Answers (Q&A) on objectives, scope, expected benefits and impacted stakeholders linked to eAF and PMS implementation.

System Demo (12 December 2024):

• System Demo recording (Timestamp: 10:55 RPM), showing the latest RPM developments and functionalities.

Recordings, presentations, Q&A Documents from events:

• Training webinar on post-authorisation procedure management in IRIS for Marketing Authorisation Holders (12 November 2024) to provide Marketing Authorisation Holders with key instructions to be prepared for the transition, showcase the IRIS system and answer questions.

Frequently Asked Questions:

• FAQ document for Industry users around the transition of RPM for PLM on IRIS.

User guides:

• User guide for Industry users to handle PLM regulatory procedures on IRIS.

Recordings, presentations, Q&A Documents from events:

• SPOR Status Update | European Medicines Agency (EMA) (22 January 2025) provides a comprehensive overview of key achievements in Q2 2024 and plans for Q3 2024 for RDM service activities (i.e. SMS, XEVMPD/Art.57, OMS, and RMS).

System Demo (12 December 2024):  

• System Demo recording (Timestamp: 11:40 UPD)

Recordings, video tutorials, Q&A Documents, etc.:

We encourage all UPD users to regularly check the below available materials on the UPD webpage to stay up to date with the latest information and UPD functionalities.

• Webinars
• Video tutorials
• Guidance for National Competent Authorities
• Guidance for Marketing Authorisation Holders
• EU Implementation Guide
• Release notes

Latest System Demo (12 December 2024):  

• System Demo recording (Timestamp: 09:25 PMS, 09:45 PUI, 10:15 ePI, 10:55 RPM, 11:25 eAF, 11:40 UPD), highlighting the latest developments in PLM systems. 

Roadmap: 2024-2026 Network Portfolio Roadmap, showing the work being conducted on digital capabilities across the Network Portfolio, including PLM.

Recordings, presentations, Q&A Documents from events:

• PLM Value Stream Deep-Dive Webinar (November 2023) Recording, providing an overview of the PLM Value Stream
• PLM Value Stream Deep-Dive Webinar (November 2023) Q&A document, including all questions asked by participants during the webinar around the PLM VS and their written answers.