The Substance and product management service webpage on EMA's corporate website has been updated.
If not yet done, please complete the conversion of your account to email authentication as soon as possible, by visiting My Account portal to login and follow the detailed instructions.
The upcoming PMS Info-Day will bring together representatives from regulatory bodies and the pharmaceutical sector to discuss the latest developments in the EU implementation of Product Management Service (PMS). A draft agenda is available, and the event will be streamed live via EMA’s YouTube channel.
Updated versions of Chapter 2 and Write PMS API IG will be released on the PMS webpage and PLM Portal later this month. The updates will refine business rules for structured data submission and update technical specifications based on industry feedback, ensuring improved accuracy, compliance, and smoother system integration.
The Product Management Service (PMS) team has created a specific PMS Data Protection Notice (DPN), in line with GDPR requirements on processing Personal Identifiable Information (PII) and European Medicines Agency (EMA) ongoing effort to promote transparency.
EMA is organising quarterly public webinars on Substance, Product, Organisation, Referentials (SPOR) Regulatory Data Management (RDM) services status update, taking place at 10:00 – 12:30 CEST on 9 April, 9 July, 8 October 2025.
EMA is organising a series of Q&A clinics (25 March, 29 April, 19 May, 17 June 2025) to answer questions regarding the PMS UI and API.
EMA is organising a public webinar on 14 March 2025, from 10:30 to 12:00 CET to explore PMS Application Programming Interface (API) Machine-to-Machine Connection. Register here to attend the event.
MAHs and NCAs users can use the EMA PMS dynamic product reports to identify the list of products and pack sizes products corresponding to the latest version of the Union list of critical medicines.
EMA is organising a webinar on 24 February 2025, from 14:00 to 16:00 CET to help Small-Medium Enterprises (SMEs) with the implementation of PMS. Register here to attend the event.
The Product Management Service (PMS) User Interface (PUI) edit functionalities - live on the Product Lifecycle Management (PLM) portal - are now available for Industry users.
EMA has introduced email address authentication for EMA applications to improve security and usability of EMA applications by removing the need for users to remember their EMA username and password.
The updated Product Management Service (PMS) roadmap for 2025 is now available. This roadmap highlights the key milestones in PMS development and essential actions for both Marketing Authorisation Holders (MAHs) and National Competent Authorities (NCAs). It will be frequently updated as new activities are planned.
The Write PMS API Implementation Guide (IG) to support the PMS enrichment process is now available on the EMA PMS Webpage. This comprehensive FHIR-based resource supports developers and stakeholders in adopting healthcare data standards, ensuring efficient and secure data exchange. For detailed steps to access and utilise the guide, visit the EMA PMS webpage
The EMA is pleased to announce a public webinar on Substance, Product, Organisation, Referentials (SPOR) services scheduled on 22 January 2025 (10:00 – 12:30 CET).
SPOR services aim to facilitate the reliable exchange of medicinal product information in a robust and consistent manner, enabling increased data quality and interoperability, 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 be provided:
- Overview and how SPOR data is used in EU systems
- Overview of SPOR achievements in 2024
- News/Achievements in Q4 2024.
- What is planned for Q1 2025 – Impacts and benefits to stakeholders
The broadcast link, agenda and presentation will be available on the event web page.
All new self-registered users are automatically set by default to email authentication.
All users not converted are requested to opt-in before 20 January 2025.
Starting from 20 January 2025 the EMA will initiate the conversion of all users that didn’t opt-in to the email authentication:
- 20 January: Non regulatory users without specific application roles;
- 3 February: Non regulatory users with application roles;
- 3 March: Regulatory users (European Medicines regulatory Network);
- 31 March: all users are converted.
How to opt in: Users are required to opt-in to email authentication in EMA Account Management by following the enclosed detailed instructions. Once converted to email authentication, users can use email address to authenticate into EMA systems, as shown in figure below.
Useful links:
- Public system demo (Q3 2024) - Presentation and recording;
- "EMA Account Management - What's new" webinar recording
Contact: EMA Service Desk; If you are unable to access Service Desk, please send an email to servicenow@ema.europa.eu indicating your name, surname and your unique username.
Key updates of EU IG Chapter 2 will concern:
- the revision of business rules;
- updates of data fields;
- applicability of labels to RMS lists supporting PMS.
ess will enable the enrichment of data concerning structured pack size, data carrier identifier(s) and manufacturer in PMS, information required by ESMP. Standardised product information availability in PMS will simplify reporting requirements for both MAHs and National Competent Authorities (NCAs) to the ESMP.
What should MAHs do now to prepare?
- Submit pack sizes in XEVMPD following Chapter 3.II instructions.
- Verify that data submitted to XEVMPD is correctly displayed in PMS – for both Centrally Authorised Products and non-Centrally Authorised Products (either through the PUI or the PMS API).
What should you do in case of any discrepancies or doubts about the data displayed? please check Chapter 7 and Chapter 9 of the EU IDMP Implementation Guide (IG), while in case of additional questions MAHs should open a EMA Service Desk Ticket by following the instructions in the “Support” section of the PUI navigation guide. - Start gathering information on structured data for pack sizes, data carrier identifier(s) and manufacturers to be ready for its submissions through PMS. Please note:
- The edit capability will be available for PMS PUI for non-CAPs by last week of January 2025 – edit in API later in Q1 2025. For CAPs, MAHs will be able to request the optional submission of data carrier data in PUI via Service Desk ticket.
- From 2 February 2025, MAHs should submit this data in PMS for all their non-CAPs listed in the “Union list of critical medicines: XEVMPD/PMS entries” final deadline is December 2025.
- EMA is organising a public webinar on 29 October 2024 (10:00 – 12:00 (CET)) to showcase the PMS PUI, recap current & future key actions for Marketing Authorisation Holders and answer users’ questions. Register here
- EMA is organising a public webinar on 25 November 2024 (10:00 – 11:30 (CET)) to explain how manufacturers and manufacturing business operations should be submitted to PMS to support the European Shortages Monitoring Platform (ESMP), providing an overview of the entire process. Register here
- 22 October 10:00 – 10:30 (CET): Register here
- 5 November 10:00 – 10:30 (CET): Register here
- 22 November 10:00 – 10:30 (CET): Register here
The PMS Application Programming Interface (API), launched on 3 July 2024 in read-only mode for industry users only, is now available for National Competent Authorities (NCAs) managing both human and veterinary medicinal products. Users from these NCAs are now able to view their non-Centrally Authorised Products (non-CAPs) (as well as CAPs) ISO-IDMP compliant human product data in the API.
Please note that selected users mentioned above can request access to PMS API via EMA Service Desk ticket here: Request SPOR API Services - Employee Center (europa.eu). The specific PMS role required for accessing the PMS API cannot be requested yet through EMA account management portal until access is available for all NCAs.
Upcoming training session: EMA is organising a dedicated training session on 2 October 2024 (10:00 – 11:30 CEST) to provide an overview of the API, and showcase the access and data read through the API. Register here (on EU-NTC platform).
Q&A Clinics: In October 2024, the PMS team will be available to answer your questions on API & Product User Interface (PUI) use during 30 mins session taking place on Tuesdays from 10:00 to 15:30 CEST:
- 22 October 2024: register here
- 29 October 2024: register here
As a reminder, the release of the NCA role for the NCAs managing human products only in EMA Account Management (IAM) for the PMS API is postponed until later in 2024/ beginning of 2025 because the testing of the new API version revealed that future registered NCAs would have access to both human and veterinary products through the API, due to the shared technology of PMS and the Union Product Database. This is not in accordance with paragraph 1 of Article 56 of Regulation (EU) 2019/6. As per the regulation, only EMA, the European Commission and selected Competent Authorities, as designated by Member States to carry out the tasks under Regulation (EU) 2019/6 in accordance with Article 137 of that Regulation, should be able to access medicinal product data for veterinary use.
If you have any question please contact plm.valuestream@ema.europa.eu or post them via the PLM Portal Forum.
The data load of non-Centrally Authorised Product* (non-CAP) information on the PMS Product User Interface (PUI) has been successfully completed. As of now, all human non-CAP and CAP data is available in read-only mode via the PUI on the Product Lifecycle Management (PLM) Portal.
Key actions for National Competent Authorities (NCAs) & Marketing Authorisation Holders (MAHs):
- NCAs & MAHs to request the new PMS roles needed for accessing the PMS PUI through the EMA Account Management portal.
- MAHs to review the non-CAP data in the PUI, ensuring consistency with the information in XEVMPD. If any discrepancies are found or there are any doubts about the data displayed, please check Chapter 7 and Chapter 9 of the EU IDM Implementation Guide (IG), while in case of additional questions MAHs should open a EMA Service Desk Ticket by following the instructions in the “Support” section of the PUI navigation guide.
- NCAs & MAHs to join the training session on 16 October 2024 (10:00 – 11:00, CEST). Register here. During the session, the PMS team will provide an overview of the PUI, showcase the access and navigation and answer your questions. Meanwhile, you can consult the presentation & recording of the previous training session on PUI, held on 3 June 2024.
- Attend Q&A Clinics (if needed): In October 2024, the PMS team will host 30-minute Q&A sessions focused on API & Product User Interface (PUI) usage:
- 22 October 2024: register here
- 29 October 2024: register here
- NCAs & MAHs to consult PMS PUI guidance documents to support their work on the PLM Portal:
- 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.
Please be reminded that this data load will not yet trigger the availability of non-CAPs data in the web-based eAF. Once performance improvements are completed, non-CAPs data will become available in the eAF.
Read access to both CAPs and non-CAPs through the PMS PUI is a key step toward the data-centric target operating model. This milestone builds on the go-live of the PMS Application Programming Interface (API) for CAPs and non-CAPs in read-only mode for MAHs on 3 July 2024 and the launch of the PMS PUI in read-only mode for CAPs on 31 May 2024.
Next steps
- In Q1 2025, the EMA plans to introduce write access for MAHs through both the PUI and API. This functionality will be crucial for shortages monitoring via the European Shortages Monitoring Platform (ESMP) in 2025, as it will enable the enrichment of structured package size, data carrier identifier(s) and manufacturer data in PMS.
- To prepare for this, Marketing Authorisation Holders (MAHs) must first submit package size data in XEVMPD (presentation & recording of dedicated July 2024 training session). Standardised product information will simplify reporting requirements for both MAHs and National Competent Authorities (NCAs) to the ESMP.
- Following this MAHs will need to submit into XEVMPD & PMS the mentioned product information by 2 February 2025 for all products in their portfolio listed in the “Union list of critical medicines: XEVMPD/PMS entries”.
If you have any question, please consult the PMS Frequently Asked Questions (FAQ) document. If your question is not answered there, please contact plm.valuestream@ema.europa.eu or post them via the PLM Portal Forum.
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)
The EMA is pleased to inform you that non-Centrally Authorised Product* (non-CAP) data are currently being loaded in read-only mode on the Product Management Service (PMS) Product User Interface (PUI), live on the Product Lifecycle Management (PLM) Portal. This data load is expected to be completed by the end of September 2024, after which all non-CAP data will be available in read-only mode on the PUI. The EMA will issue a communication as soon as the load is completed.
IMPORTANT: To avoid platform overload and preserve the performance of the PLM platform while the data load is ongoing, the EMA requests that Marketing Authorisation Holders (MAHs) refrain from requesting PMS roles at this time. Current PLM PUI and eAF users are also strongly encouraged to minimise activity on the PLM Portal.
Please note, this data load will not yet trigger the availability of non-CAPs in the web-based electronic Application Form (eAF). Further performance improvements are currently being made in the eAF and following the deployment of these improvements the non-CAP products will become available also in the eAF. During the non-CAP data load, users of the PLM Portal and IRIS Industry & Network Portal may experience minor performance issues, such as slower system responses. In such circumstances, users do not need to raise this via EMA service now.
After the data load is completed, read access to both CAPs and non-CAPs through the PMS PUI will be available. This is a key step toward the data-centric target operating model. This milestone builds on the go-live of the PMS API in read-only mode for MAHs on 3 July 2024 and the launch of the PMS PUI in read-only mode for CAPs on 31 May 2024.
In Q1 2025, the EMA aims to release write access for MAHs through both PMS PUI and API, which will be essential for shortages monitoring in 2025 through the enrichment of structured package size information and manufacturer data. To facilitate this, MAHs must first submit package size data in XEVMPD.
Using the PUI
User are requested to take note that:
- During the data load period access request should be deferred until after completion the data load is complete – expected end of September
- After the data load is complete, MAHs will be invited to request the new PMS roles required for accessing the PMS PUI through the EMA Account Management portal.
- Revision of relevant PMS data is a priority after the load is completed. All MAHs are recommended to review relevant non-CAPs’ information in PMS PUI, i.e. check that the data is consistent with the information in XEVMPD. If any discrepancies are found or there are any doubts about the data displayed, please check Chapter 7 and Chapter 9 of the EU IDM Implementation Guide (IG), while in case of additional questions MAHs should open a EMA Service Desk Ticket by following the instructions in the “Support” section of the PUI navigation guide.
- PMS PUI guidance documents are available to support this work on the PLM Portal:
- 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.
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)
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 provided link 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.
Find here an overview of guidance documents to be published this quarter, in particular concerning updates of EU IDMP Implementation Guide (IG) Chapters and Product User Interface (PUI) navigation guide.
- End of July/ early August 2024
- EU IDMP IG Chapter 1: update diagram on PMS API registration and addition of references to PMS API role in IAM.
- EU IDMP IG Chapter 5 (including Annex A): update to include the latest information in terms of public access to PMS data.
- Product User Interface (PUI) navigation guide: update information on all dynamics report and public report.
- September 2024
- EU IDMP IG Chapter 2: update on RMS information, data model, clarification of specific data elements - business rules.
This milestone also follows on the read-only go-live of PMS Application Programming Interface for CAPs and NAPs on 3 July 2024.
Read access to PMS is an important step on the roadmap towards establishing a data-centric target operating model. In Q4 2024, EMA aims to release write access for PMS (for NAPs). This will enable marketing authorisation holders to enrich package size and manufacturer data for shortages monitoring in 2025. To enrich package size data, MAHs must submit package size data in XEVMPD first.
Key action for MAHs: In an important preparatory step to enhancing data later in 2024, read access through the API and PUI enables MAHs to review relevant products’ information, i.e. check that the data is consistent with the information in XEVMPD. If any discrepancies are found or there are any doubts about the data displayed, MAHs should open a EMA Service Desk Ticket.
If you have any questions on the PUI or API, you are invited to join the dedicated 30 min Q&A Clinic taking place on 23 July 2024, 10:00 – 10:30 (CEST). Register here.
You can consult the following PMS PUI guidance documents on the PLM Portal:
- 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.
On 3 July 2024, the read-only mode of the Product Management Service (PMS) Application Programming Interface (API) has gone live for registered users and is now accessible for all Marketing Authorisation Holders (MAHs).
Registered Industry users can now view Centrally Authorised Product (CAP) and Nationally Authorised Product (NAP) ISO-IDMP compliant data in the API.
The general release of the National Competent Authority (NCA) role in EMA Account Management for the PMS API is postponed until later in 2024, when the version of the API is updated to enable the release of the access.
This milestone is part of the roadmap toward a data-centric target operating model. The go-live of the PMS API read-only mode follows the go-live of PMS Product User Interface (PUI) read-only mode for CAPs, which took place on 31 May 2024.
Key action for MAHs
In an important preparatory step to enhancing data later in 2024, read access through the API and PUI enables MAHs to review relevant products’ information, i.e. check that the data is consistent with the information in XEVMPD. If any discrepancies are found or there are any doubts about the data displayed, MAHs should open a EMA Service Desk Ticket.
Using the API
Please note that the new PMS role required for accessing the PMS API can now be requested (for Industry users) in the EMA Account Management portal.
Upcoming training session: EMA is organising a public webinar on 8 July 2024 (14:00 – 15:00 CEST) to provide an overview of the API, and showcase the access and data read through the API. Register here, and consult the event web page for further information.
Q&A Clinics: Throughout the month of July 2024, the PMS team will be available to answer your questions on Product User Interface and API use during two 30 mins sessions:
- 16 July 2024 (10:00 – 10:30 CEST): register here
- 23 July 2024 (10:00 – 10:30 CEST): register here
The below guidance documents include information on how to access the PMS API:
- On-boarding of users to Substance, Product, Organisation, and Referentials (SPOR) data services: Updated to include an explanation of PMS PUI & API roles and role differences from Referentials Management System (RMS) and Organisation Management System (OMS).
- EU IDMP Implementation Guide (IG) Chapter 1: Updated registration requirements reflecting changes in the PMS registration process.
If you have any question please contact plm.valuestream@ema.europa.eu or post them via the PLM Portal Forum.
This public webinar is taking place on 11 July 2024 (10:00 – 11:30 CEST).
The session will provide an overview of the entire process specifically related to how pack sizes information should be submitted to XEVMPD to support the European Shortages Monitoring Platform (ESMP) and how they will be incorporated into PMS, .
The training will also offer tips to applicants on submitting this information effectively.
Register to attend the event.
Agenda, presentation and recording will be published on the event web page.
2024/07/10 - SPOR Status Update Webinar
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.
Following the go-live of the PMS API – taking place on 1st week of July – for both Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs), the EMA will host a public online training session on 8 July 2024 (14:00 – 15:30 CEST).
During the session, the PMS team will provide a thorough explanation on access to and data read through the PMS API.
Register to attend the event.
Agenda, presentation and recording will be published on the event web page.
As of today, 31 May 2024, the Product Management Service (PMS) Product User Interface (PUI) has gone live in read-only mode for registered users via the Product Lifecycle Management (PLM) Portal.
Registered users (Marketing Authorisation Holders and National Competent Authorities) can now view Centrally Authorised Product (CAP) data. Nationally Authorised Product (NAP) data will be available on the PUI in read-only mode by the beginning of Q3 2024.
This milestone is part of the roadmap toward a data-centric target operating model. Write access for PMS, planned for Q4 2024, will be crucial for enhancing package size and manufacturer data for 2025 shortages monitoring. MAHs must first submit package size data in XEVMPD.
Due to quality concerns in the read functionality of the PMS Application Programming Interface (API), the latter will be released at the beginning of July 2024, instead of today. The API will also go live in read-only mode for both CAPs and NAPs data.
Using the PUI
- The new PMS roles required for accessing the PMS PUI can now be requested in the EMA Account Management portal.
- Data Review: MAHs must check that their product information in PMS PUI is consistent with XEVMPD. Discrepancies or doubts should be reported via an EMA Service Desk Ticket following the “Support” section of the PUI navigation guide.
- Training Session: A public webinar on 3 June 2024 (10:00 – 11:30 CEST) will provide an overview of the PUI and API, with specific training on PUI. Register here, and consult the event web page for further information.
- Q&A Clinics: Weekly 30-minute sessions every Thursday in June (15:00 – 15:30 CEST) to answer PUI-related questions:
- 6 June 2024: register here
- 13 June 2024: register here
- 20 June 2024: register here
- 27 June 2024: register here
Guidance Documents:
- PMS Product UI registration guide
- PMS Product UI navigation guide
- PMS Product UI known issues document
Additional Guidance:
- On-boarding of users to Substance, Product, Organisation, and Referentials (SPOR) data services: Updated to include an explanation of PMS PUI & API roles and role differences from Referentials Management System (RMS) and Organisation Management System (OMS).
- EU IDMP Implementation Guide (IG) Chapter 1: Updated registration requirements reflecting changes in the PMS registration process.
A public product report named “Human Medicinal Product Overview report” with limited CAP data is also available on the PLM Portal without registration, following the principles stated in EU IG Chapter 5 (PMS data access level 1).
We have updated several guidance documents in preparation for the go-live of PMS Product User Interface (PUI) & Application Programming Interface (API) taking place on 31 May 2024. Please note that the new PMS roles required for accessing the PMS Product UI and Application Programming Interface (API) will be available for request starting from 31 May 2024. Access to the PMS Product UI and API will be granted from this date.
Please find below the list of updated chapters:
- On-boarding of users to Substance, Product, Organisation, and Referentials (SPOR) data services has been updated, including an explanation of PMS PUI & API roles and differences from other Referentials Management System (RMS) and Organisation Management System (OMS) roles.
- Introduction to EU IDMP IG: This includes a general update on the latest chapters released.
- EU IDMP IG Chapter 1: Registration requirements have been updated to reflect changes in the PMS registration process.
- EU IDMP IG Chapter 5 (including Annex A): Data access/export has been updated to include the latest agreement with NCAs regarding PMS data sharing.
Additionally, the following PMS PUI guidance documents are now available on the PLM Portal:
- PMS Product UI registration guide
- PMS Product UI navigation guide
- PMS Product UI known issues document
Finally, on 31 May 2024, we will publish PMS public product reports with a limited amount of information on the PLM Portal, accessible to the public without registration as per principles stated in the EU IG Chapter 5 (PMS data access level 1).
New, product-specific tiles for electronic Product Information (ePI) and the Product Management Service (PMS) Product User Interface have beein included in addition to the web-based electronic Application Forms on the PLM Portal's landing page. To ensure users can find and easily access these tools, EMA has updated the landing page of the Portal, which now presents a new look & feel.
The new interface aims to provide more intuitive access to eAF, PMS and ePI release notes, news, knowledge articles.
We would like to invite you to share your feedback on the new landing page in the PLM Portal Forum.
Viewing capabilities for PMS product data will be launched in May. Marketing Authorisation Holders will be able to view data using the PMS Product User Interface (PUI) or a machine-to-machine interface. This training webinar will show and explain the access and navigation for these two tools. The webinar is for industry and Network stakeholders working on regulatory affairs.
Date: Monday, 3 June 2024
Time: 10:00 - 11:30 (CEST)
Registration: WebEx registration page
This important milestone for Product Management Services (PMS) follows testing by selected Industry and Network stakeholders in March 2024.
The Product User Interface user guide and the updated version of EU Implementation Guide Chapter 1 detailing the registration process will be available in on the day of the go-live, i.e. 31 May 2024.
Upcoming milestones for PMS in 2024 are:
- Q3 2024:
- Launch of Nationally Authorised Product (NAPs) data on IRIS - This means that this PMS data becomes available to other systems such as ESMP. All product data, including NAPs data, will be available in to view in the Product User Interface.
- Q4 2024:
- NAPs release in web-based eAF - Human variations through web-based eAF will become available for NAPs in addition to CAPs.
- Release of PMS enrichment process - MAHs can start providing missing or incomplete product data such as manufacturers, structured pack sizes or data carriers, manually via the user interface or via the system-to-system interface using the PMS API.
- Introduction to EU IDMP IG - general update to the latest chapters released and opening of PMS adjust chapters’ scope presented
- EU IDMP IG Chapter 1: Registration requirements - updated PMS registration process
- On-boarding of users to Substance, Product, Organisation and Referentials (SPOR) data services – updated with explanation of PMS PUI & API roles and differences of other RMS and OMS roles
- EU IDMP IG Chapter 5 (including Annex A): Data access/ export - update with updated to include the latest agreement with NCAs in terms of PMS data sharing
- Product UI user guides publication (registration, navigation, known issues)
EMA, NCAs and representatives of industry gathered in Amsterdam on 16 April 2024 to review what industry and regulators must do to ensure complete and correct product data in EMA’s new medicinal product database, PMS. EMA is currently developing the Product User Interface hosted on the PLM Portal, as well as an system to system interface to enable companies to enhance their data.
These tools will be launched later this year to enable enrichment of data for shortages monitoring through the European Shortages Monitoring Platform (ESMP) as well as data for other systems. The PMS Info Day represented a big step in driving awareness and action among the key actors.
During the event, EMA announced the data migration from XEVMPD and EMA’s internal database, SIAMED, and continuous synchronisation with PMS has been completed. This is an important milestone and means Centrally Authorised Products' (CAPs) and Nationally Authorised Products' (NAPs) data are available in PMS in ISO IDMP compatible format. This data will be viewable later this year once the viewing capabilities of the Product User Interface (PUI) and the machine-to-machine capabilities of the application programming interface (API) become available in May.
PMS data will enable key regulatory systems being developed as part of EMA’s Network Portfolio. This includes electronic application forms (eAF), regulatory procedure management (IRIS), electronic product information (ePI), the future European Shortages Monitoring Platform (ESMP) and the Antimicrobial Sales Use (ASU) platform. During the PMS info day, each system highlighted the importance PMS data to generate efficiencies and ensure effective delivery of benefits.
The needs of these systems dictate the product data requested. The immediate focus is on the data required to enable ESMP, while other systems may have additional data requests in 2025 and beyond. This iterative, step by step approach means that there will be no big bang request to complete and enhance PMS data.
Key actions highlighted for industry stakeholders during the event were:
- Marketing Authorisation Holders to start providing additional information through XEVMPD, the existing database, on:
- Pack sizes for NAPs under the union list of critical medicines (ESMP)
Deadline: February 2025 - Herbal or homeopathic products used in the variation eAF
No deadline
- Pack sizes for NAPs under the union list of critical medicines (ESMP)
- After being granted read-only access to Product UI and PMS API at the end of May 2024, MAHs should review their medicinal products in PMS in preparation for enrichment.
- As of Q4 2024, using the Product UI or PMS API, MAHs should enrich data for manufacturing business operations, structure data on pack sizes for NAPs under the union list of critical medicines (ESMP) (final deadline: December 2025).
- Mitigate impacts of missing or incorrect Substance, Organisation, Referentials mapping by reviewing substances data (SMS) and referentials data (RMS) exports and MAH organisation information in organisational data (OMS) to ensure their Products in XEVMPD do not use any of the data that is or will be made non-current. MAHs should also use replacement substances and terms whenever possible.
During the event, an NCA, AGES, shared the path towards and benefits of PMS from the perspective of a National Competent Authority. Finally, two Marketing Authorisation Holders, Merck and Roche, took the floor to share how they have created data governance to support their regulatory data needs, including IDMP and PMS.
The agenda for the event as well as the slides used are available. The recording of the event will be available shortly on the event page.
If you attended the event (online or on-site), you still have the chance to leave your feedback on Slido.com and entering the event code #PMSINFO or by using this link.