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Guidance & training material available to support the users of the PLM Portal - eAF in accessing and navigating through the platform.
Guidance & training material available to support the ePI pilot participants in accessing and navigating through the platform Electronic Product Information (ePI).
Guidance & training material available to support the PMS users in accessing and navigating through the platform
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As of 29 September 2025 EMA has started strongly recommending the use of the PLM Portal web-based eAF for all non-CAPs human variations. This step is aligned with the roadmap towards mandatory use of the PLM Portal web-based eAF for all human variations.
Following the launch of optional use in February 2025, EMA now recommends the use of the PLM Portal web-based eAF for all non-CAPs human variations, where possible. To provide support during this transition, EMA will host two dedicated training sessions and two Q&A sessions.
A new PLM Portal eAF Q&A document is now available: Q&A Document
In a progression towards eventual transition, from late Q3 2025, EMA will strongly recommend use of the web-base eAF for non-CAPs applications, with the PDF version to be used only in exceptional cases. EMA currently already recommends using the PLM Portal web-based eAF for all non-CAPs human variation applications and already strongly recommends it for all CAPs human variations.
The registration for the Q&A Clinic on web-based electronic Application Form (eAF) for CAPs and non-CAPs on 8 July 2025 10:00 - 11:00 (CEST) is still open.
The registration for the training session on Human variations web-based electronic Application Form (eAF) for non-CAPs on 1 July 2025 10:00 - 11:30 Amsterdam time (CEST) is still open.
Following the launch of optional use in February 2025, EMA now recommends the use of the PLM Portal web-based eAF for all non-CAPs human variations, where possible.
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.
EMA would like to provide you with an update on the progress of the web-based Human variations electronic Application Form (eAF) implementation on the Product Lifecycle Management (PLM) Portal.
EMA is pleased to announce that the PLM Portal eAF Integrity stamp feature will be deployed Thursday, 6th of March, after 18:00 CET.
The EMA is pleased to confirm as of Tuesday 11 February 2025, the human variations web-based electronic Application Form (eAF) is open for first use for non-Centrally Authorised Products* (non-CAPs) within the PLM Portal.
Several chapters of the EU IDMP Implementation Guide (IG) and the Product Management Service FAQ document have been updated.
The following EU IDMP IG Chapters are now updated:
Chapter 5 - Annex A
The Frequently Asked Document (FAQ) document for PMS was also updated with information on the status of PMS known issues.
Please note, the write PMS API implementation guidance will be published after 6 January 2025. We apologise for any inconvenience this may cause.
The expected start date of the strongly recommended use of the PLM Portal web-based eAF submissions to the National Competent Authorities for non-CAPs variations is now planned for February 2025.
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.
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:
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:
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.
Non-Centrally Authorised Products* (non-CAPs) data are now available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal. This is a further important step towards the progressive increase of the use of the PLM Portal web-based eAF for all non-CAPs and CAPs variations.
The EMA is pleased to announce that, as of the 14 October 2024, non-Centrally Authorised Products* (non-CAPs) data will be available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal.
In a further step towards progressively increasing the use of the PLM Portal web-based eAF for all CAPs variations, EMA now strongly recommends applicants use it for these applications in anticipation of eventual required use. Additionally, EMA is planning to extend the use of the PLM Portal web-based eAF for non-CAP procedures concerning variations for human medicines.
Please note that, while CAPs data is available as of 16 April, we strongly recommend that no applications using the PLM Portal web-based eAF is used for submissions at the moment. This is due to the fact that the updated CAPs load has impacted how products appear in application forms (e.g., changes to product names, introduction of new medicinal products through splitting, potential alterations to packages, etc.) and some minor adjustments to the functionalities of the web based eAF are needed.
We suggest using the interactive PDF eAF instead of the web-based eAF for submissions to prevent validation issues and potential delays. The EMA will announce the date from which the use of the PLM web-based eAF form can be resumed.
*Including split & match-merge processes. Please refer to EU IG (Implementation Guide) Chapter 7 for a detailed description of these steps.
The PMS Product User Interface (PUI) was launched on 31 May 2024, in read-only mode on Product Lifecycle Management (PLM) Portal. Registered users are now able to view Centrally Authorised Product - (CAP) data in the PUI, while Nationally Authorised Product (NAP) data will be available in early Q3 2024.
Please note that the eAF users have now automatically access to the PUI. Consult these guidance documents and consult the 3 June 2024 training session to prepare for registration & navigation of PUI.
As anticipated in April 2024 communication and announced in May 2024 at the webinar “Information and Q&A session on updated CAPs in web-based eAF” (recording & presentation available), we have completed the load of updated* Centrally Authorised Products (CAPs) data to PLM Portal web-based eAF on 19 April 2024. Users can now access this new CAP product data directly within the web-based forms.
We are pleased to announce that we recommend the use of the PLM Portal web-based eAF for all CAPs variations starting from 14 May 2024. However, please be aware that there are still some known issues and limitations that we are actively addressing however, these issues do not prevent the use of the web-based eAF. We invite you to consult the 7 May webinar presentation for the complete list of known issues.
If you encounter any issues, please report them via EMA Service Desk, ensuring that you select the correct category.
*Including split & match-merge processes. Please refer to EU IG (Implementation Guide) Chapter 7 for a detailed description of these steps.
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. |
EMA will host an Information and Q&A session on 7 May 2024, 10:00 – 11:00 (CEST) to explain and showcase the changes in the PLM Portal web-based Human Variations eAF after the updated Centrally Authorised Products (CAPs) load. Participants will have the opportunity to ask questions in the last part of the session.
The participation is recommended to Industry stakeholders working on regulatory affairs of their respective organisations.
Register here, and check the event web page for agenda, presentation and recording, all to be published in due time.
Due to planned maintenance activities, the interactive PDF eAFs (human and veterinary variation and MAA forms and the renewal form) and the PLM Portal web-based eAF will be unavailable for use between 11th and 16th April 2024.
Additionally, as announced in December 2023, the PLM Portal web-based eAF will be affected by the data load of Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) into Product Management Service (PMS) as well as the simultaneous load of updated* CAPs to web-based eAF.
This load of data into PMS is a necessary step in preparation to the forthcoming launch of the Product User Interface view and later edit functions as well as making NAPs data available for the PLM Portal web-based eAF.
The data load will take place from 11 to 16 April 2024. During this timeframe, the interactive PDF eAF and the PLM Portal web-based eAF will experience a downtime.
Please note that, during the preparation for the updated* CAPs load in the PLM Portal web-based eAF, the match-merge** operation will result in:
These changes will impact how products appear in application forms. Therefore, we strongly recommend, with immediate effect, that no applications that might require any update of the eAF, during or after the product upload, are submitted to EMA using the PLM Portal web-based eAF. We strongly recommend to use the interactive pdf eAF instead of the web-based eAF for submissions at least until 26 April 2024 to prevent validation issues and potential delays.
Please note that if you have already submitted a web-based eAF, or it is expected that there will be no need to update the form and/or the procedure will conclude prior to the downtime, you can continue using the web-based eAF.
Please note that, except for the downtime period, the web-based eAF is expected to remain accessible to applicants to familiarise themselves with changes to the products, and for training purposes.
*Including split & match-merge processes. Please refer to EU IG (Implementation Guide) Chapter 7 for a detailed description of these steps.
**The “Match-merge” process serves to include data from XEVMPD to products already released in PLM Portal. The “split” process serves to make released products ISO-IDMP compliant. Both processes are explained in detail in EU IG Chapter 7
The PLM Portal eAF and PMS teams are pleased to announce that the updated Frequently Asked Questions (FAQs) on eAF and PMS and Questions and Answers (Q&A) Joint eAF and PMS are now available on the eSubmission website.
The electronic Application Form (eAF) Product Team would greatly appreciate to receive your feedback on your current experience in terms of time spent in filling in the interactive pdf electronic Application Form (eAF) for Variations for Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs), and Initial Marketing Authorisation.
It is acknowledged that different types of procedures (e.g. Type IA, Type II applications, worksharing, and groupings) may require varying time commitments. We would therefore appreciate if, in your answer, you could provide the average time spent and resources used to fill in the forms.
Your feedback will provide us an indication on the current performance requirements and will be our starting point for improving future user experience.
You can find the questionnaire to fill in at the following link:
https://ec.europa.eu/eusurvey/runner/Eusurvey_PLMPortal_UX_eAFcompletion
Please note that this survey should not take more than 5 minutes to complete, and the responses will remain anonymous.
We kindly ask you to respond to the survey by Thursday 29 February 2024.
Please send any question to plm.valuestream@ema.europa.eu or post them via the PLM Portal Forum.
As anticipated in October 2023, the electronic Application Form (eAF) and Product Management Service (PMS) teams would like to provide you with an update on the progress of the web-based Human variations eAF implementation on the Product Lifecycle Management (PLM) Portal
During Q4 2023, we completed the load and evaluation of PMS data in PMS User Acceptance Testing (UAT) environment, after which we proceeded to testing of PMS data in the PLM Portal. While performing these activities, we observed the following:
Bugs in PMS related to match-merge* of Centrally Authorised Products (CAPs);
Technical issues with the eAF preventing testing;
System performance improvements required for the PLM Portal.
Taking into consideration these findings, we have made the necessary adjustments to planning.
Please note that Alpha UAT for Product User Interface (UI) data quality is still ongoing and proved successful thus far, as no blocking bugs have been identified.
Key points of the updated plan:
Q1 2024:
Deployment in production of new eAF features (e.g., clone application, add package, rename application) developed in Q4 2023.
Consolidation of all PLM portal products' development (eAF, Product UI, ePI) under a single service provider.
Q2 2024:
Release of all CAPs & NAPs in the PMS database. Simultaneously, release of updated** CAPs in eAF;
Delivery of PMS Application Programming Interface (API) - with CAPs and Nationally Authorised Products (NAPs) available in view-only mode - and Product UI - with CAPs available in view-only mode and NAPs not yet viewable.
Please note that, during the preparation for the updated** CAPs load in eAF in Q2 2024, the match-merge* operation will result in:
changes to product names;
introduction of new medicinal products through splitting*;
potential alterations to packages;
This will impact how products appear in application forms. Therefore, we will communicate in due course the 3-week period where it is advisable to use the interactive eAF (PDF) instead of the web-based eAF for submissions to prevent validation issues and potential delays. Please note the web-based eAF will remain accessible to applicants to familiarise themselves with it and for training purposes.
Q3 2024:
Performance improvements and internal testing
Q4 2024:
Release of NAPs in the eAF
The updated planning does not foresee in 2024:
external testing of the eAF UAT
consequently, no transition start towards mandatory use of the Human variations web-based eAF. However, we would recommend the use of the web-based eAF for CAPs submissions following the updated** CAPs release.
Please send any questions to plm.valuestream@ema.europa.eu or post them via the PLM Portal Forum.
*The “Match-merge” process serves to include data from XEVMPD to products already released in PLM Portal. The “split” process serves to make released products ISO-IDMP compliant. Both processes are explained in detail in EU IG Chapter 7
**Including split & match-merge processes. Please refer to EU IG Chapter 7 for a detailed description of these steps.
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.12 released to production on 27 November 2023 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
An updated version of the PLM Portal eAF FHIR XML Release notes reflecting the implementation of FHIR XML 1.2.0 in the PLM Portal eAF (to be released to production on 21 November 2023) are now available on PLM Portal Forum.
The electronic Application Form (eAF) and Product Management Service (PMS) teams would like to provide you with a comprehensive update on the progress of the web-based Human variations eAF implementation on Product Lifecycle Management (PLM) Portal.
The following milestones are now for Q1 2024:
As we advance, we remain committed to transparency and will provide a comprehensive update on these targets at the end of Q4 2023, evaluating the quality of both the system and available data.
Currently, our primary focus is ensuring quality of data and system's performance to prepare a transition-ready version of the web-based Human variations eAF. To begin the transition phase towards mandatory use of web-based Human variations eAFs, the following key steps are required:
As previously committed, any announcement concerning the starting date of the formal transition period will follow User Acceptance Testing (UAT) of the system and the subsequent addressing of any critical issues.
The primary objective remains to implement web replacements of interactive PDF eAFs, enabling user-friendly capture and handling of variations, marketing authorisations, and renewals application data for both applicants and regulators. This transition ensures consistency across IT systems and guarantees the availability of high-quality ISO IDMP compliant information.
For further details on the implementation progress and challenges, and the opportunity to ask questions, interested parties are invited to the joint eAF-PMS webinar for 6 November 2023 (13:30 - 15:00 (CEST)). During this session, the eAF team will also demonstrate the anticipated "add package" and "clone application" features that will be released on the PLM Portal for eAF. Please find here the registration link.
We also recommend that anyone with an interest in the development of eAF and PMS watch the relevant sections of the Q3 System Demo recording, available on EMA's website.
Please send any questions to plm.valuestream@ema.europa.eu or via the PLM Portal Forum.
*CAPs migrated from SIAMED not following ISO IDMP structure. For this reason, they have undergone a further step in the data migration to PMS in addition to the match and merge protocol.
Your experience with SPOR and XEVMPD is important to us. To help us continuously improve our services, we invite you to share your views through our customer satisfaction survey.
The PMS Product User Interface (PUI) Bulk Write and the PMS Application Programming Interface (API) Write Access functionalities are now live.
Extension of PMS submission deadlines for the enrichment for non-Centrally Authorised Products (part of ULCM) to June 2026 and all other non-Centrally Authorised Products to June 2027. The December 2026 deadline for structured Manufacturer's data remains unchanged.
Following the completion of User Acceptance Testing (UAT), new PMS functionalities for non-CAPs enrichment will be released for industry users in September 2025. To support their use, EMA will provide dedicated training webinars in October 2025.
An updated version of Chapter 2 of the EU IDMP Implementation Guide (IG) is now available, while an updated version of PMS Application Programming Interface (API) Write IG will be released on 11 August 2025. Please find both documents in the PMS webpage.
An updated version of Chapter 9 of the EU IDMP Implementation Guide is now available, with Annex III of Chapter 2 to follow later in Q3. A new file named PMS-PLM-ESMP-eAF data matrix will also be released in Q3. The PMS team will host two webinars in October to present insights and training on Bulk Edit (PUI) and Write (API) functionalities.
From September to December 2025*, EMA’s Regulatory Data Management Services Team will host two monthly public 1-hour Q&A clinic series targeted at users of the Substance, Organisation, and Referentials (SOR) and XEVMPD services.
*Note: Based on participants’ feedback, this period is likely to be extended beyond December 2025.
EMA, NCAs, and Industry stakeholders align on next steps for PMS integration and data readiness
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:
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:
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:
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?
Upcoming informative webinars:
Upcoming Q&A Clinics on PUI and API:
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:
The EU IDMP Implementation Guide (IG) Chapter 1 includes updated registration requirements reflecting changes in the PMS registration process.
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):
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
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:
* 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:
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.
The following guidance documents will be published this quarter:
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:
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:
The below guidance documents include information on how to access the PMS API:
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:
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
Guidance Documents:
Additional Guidance:
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:
Additionally, the following PMS PUI guidance documents are now available on the PLM Portal:
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:
The following guidance documents will be published in May 2024:
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:
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.
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