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14-10-2024
Non-Centrally Authorised Products now available in the PLM Portal eAF
The EMA is pleased to announce that the non-Centrally Authorised Products* (non-CAPs) data are now available in the Human variation web-based eAF within the Product Lifecycle Management (PLM) Portal.
Please note that, due to system limitations and pending future improvements, the web-based eAF cannot currently be used for submissions to the National Competent Authorities. However, the web eAF is fully functional for the submission of variations of CAPs, including EMA-led worksharing variations containing CAPs and non-CAPs.
Please join the training session on 17 October 2024 10:00 - 11:30 (CEST).
Please see an updated version of the draft PLM Portal eAF guide to navigation is now available.
04-10-2024
EU eCTD v4.0 draft Implementation package now available
An updated draft version of the EU eCTD v4.0 implementation package is now available here.
The package contains the following:
- EU eCTD v4.0 Implementation Guide draft version 1.2 ; this version is focused on CAPs and the main changes since version 1.1 are reflected in the "Document change history" of the file
- EU eCTD v4.0 Controlled Vocabularies, in .xlsx format (version 1); the genericode files (.xml format) will be published in the following weeks
- EU eCTD v4.0 Accepted file formats
An upcoming updated package (containing the genericode files for the controlled vocabularies and the validation criteria) will be made available in the coming period.
The package is meant for eCTD tool vendors to access the new format of the Controlled Vocabularies and the new OIDs, as well as to be notified by the changes in the EU eCTD v4.0 Implementation Guide (version 1.2).
According to the EU eCTD v4.0 implementation timeline, a technical pilot for eCTD v4.0 in EU (focused on CAPs) is planned to start by the end of 2024, and more details will be published on the eSubmission website. If you are an eCTD tool vendor, have already developed eCTD v4.0 capabilities in the tool and are interested in participating in the EU eCTD v4.0 pilot, follow the eSubmission website for the upcoming announcement, or send your intention to join the pilot at ectd4consultation@ema.europa.eu.
03-10-2024
Non-CAPs data available in the PLM Portal web based eAF from 14th October 2024
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.
Please note that, due to system limitations and pending future improvements, the web-based eAF cannot currently be used for submissions to the National Competent Authorities. However, the web eAF is fully functional for the submission of variations of CAPs, including EMA-led worksharing variations of non-CAPs.
In order to familiarise with the new functionality of web-based eAFs for Human non-CAP variation procedures, the eAF team is providing a dedicated training session on 17 October 2024 10:00 - 11:30 (CEST). During this event, access and navigation of web-based eAF for non-CAPs will be showcased. We would highly recommend all relevant Industry stakeholders to participate to this training: Register here
Key actions for Marketing Authorisation Holders:
- Register as an eAF user in the PLM Portal following the registration process and log into the eAF for familiarisation and testing purposes;
- Join upcoming training session;
- Follow EMA announcements to be informed of the date when web-based eAF can be submitted to the NCAs. This is currently expected to start in January 2025;
- Continue to submit the interactive PDF eAFs to the NCAs for non-EMA led procedures;
- Gather user feedback related to non-CAP variations within your organisations (MAHs and industry organisations) and to provide this consolidated feedback to EMA via plm.valuestream@ema.europa.eu.
Key actions for NCAs to:
- Follow EMA announcements to be informed of the date when they will start receiving web-based eAF submissions.
- Forward any non-CAP variations related user feedback from MAHs to EMA via plm.valuestream@ema.europa.eu
- Join upcoming information session on the go-live of the web-based eAF for non-CAPs - to take place in November 2024.
eAF guidance documents available to support your work on the PLM:
- Guide for PLM Portal Registration - Document
- Guide for PLM Portal eAF Navigation - Document
Please be reminded that:
- External testing of the eAF User Acceptance Testing (UAT) is not foreseen for 2024
- No transition towards mandatory use of the Human variations web-based eAF will start before a UAT takes place
If you have any question 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)
01-10-2024
Planned maintenance of eSubmission systems on 8 October 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Tuesday 8 October 2024, between 18:00 and 20:00: Gateway XML delivery file user interface, Gateway Filehandler and PSUR Repository Web-UI (relevant for NCAs only).
The maintenance includes the aligning of the VNeeS submission format to 3.1, where applicable, and other small improvements.
Previously created delivery files will not continue to work, please use the new version of the Gateway XML delivery file after the maintenance has completed.
Updated documentation will be published on the relevant pages of the eSubmission website. For any further information, please contact EMA Service Desk.
20-09-2024
Updated PLM Portal eAF guide to navigation now available
An updated version of the draft PLM Portal eAF guide to navigation is now available.
And
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.19 released to production on 18 September 2024 are now available on PLM Portal and on the PLM Portal eAF web page.
19-09-2024
Completion of non-CAPs data load on PMS Product UI
The EMA is pleased to inform you that 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.
National Competent Authorities and Marketing Authorisation Holders can now request the new PMS roles needed for accessing the PMS PUI through the EMA Account Management portal. A training session is scheduled for 16 October 2024 (10:00 - 11:00, CEST), where the PMS team will provide an overview of the PUI, showcase the access and navigation and answer your questions. Registration is available here. Meanwhile, you can consult the presentation & recording of the previous training session on PUI, held on 3 June 2024, and the PMS PUI guidance documents.
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.
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)
11-09-2024
Start of non-CAPs data load on PMS Product UI
The EMA is pleased to inform you that non-Centrally Authorised Products* (non-CAP) data are currently being loaded in read-only mode on the Product Management Service (PMS) Product User Interface (PUI), live on the 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.
IMPORTANT: To avoid platform overload and preserve the performance of the PLM platform while the data load is ongoing, the EMA requests that National Competent Authorities (NCAs) 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). Following the deployment of further performance improvements, non-CAPs 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 Desk.
* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)
06-09-2024
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.18 released to production on 06 September 2024 are now available on PLM Portal and on the PLM Portal eAF web page.
28-08-2024
Updated PLM Portal eAF guide to navigation now available
An updated version of the draft PLM Portal eAF guide to navigation is now available. The change is in chapter 2.2.4 (Add product), page 40, and it is related to the introduction of a temporary popup message, while the adding of the products and all the afferent processes are finalised.
And
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.17 released to production on 27 August 2024 are now available on PLM Portal and on the PLM Portal eAF web page.
27-08-2024
Planned maintenance of the eSubmission Gateway XML delivery file on 2 September 2024
Due to planned maintenance, the eSubmission Gateway XML delivery file will not be available on Monday 2 September 2024, between 18:00 and 19:00. For any further information, please contact EMA Service Desk.
08-08-2024
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.16 released to production on 08 August 2024 are now available on PLM Portal and on the PLM Portal eAF web page.
23-07-2024
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.15 released to production on 22 July 2024 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
22-07-2024
Updated PLM Portal eAF guide to navigation now available
An updated version of the draft PLM Portal eAF guide to navigation is now available.
17-07-2024
Updated PLM Portal eAF Release notes now available
An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.0.1.14 released to production on 15 July 2024 are now available on PLM Portal Forum and on the PLM Portal eAF web page.
11-07-2024
Invitation to register for the Info Session on PLM Portal eAF - Add package
EMA will host an Information session on 18 July 2024, 11:00 - 12:00 (CEST) to explain and showcase the latest developments and bug fixes deployed in the PLM Portal web-based electronic Application Form (eAF), namely the add package feature. Participants will have the opportunity to ask questions in the last part of the session.
The eAF add package functionality allows the applicants to use the web based eAF for variations adding a new pack size.
The participation is recommended to Industry stakeholders who are filling in application forms for their respective organisations.
Register here, and check the event web page for agenda, presentation and recording.
01-07-2024
Updated PLM Portal eAF FHIR XML Release notes now available
An updated version of the PLM Portal eAF FHIR XML Release notes reflecting the implementation of FHIR XML 2.0.1 in the PLM Portal eAF (released to production on 28 June 2024) are now available on the PLM Portal and in the section of the PLM Portal eAF, Documentation section, together with several updated documents to provide consumers of the FHIR XML message the easiest possible way to upgrade to the eAF XML 2.0.1 or to start the implementation now with the latest version.
18-06-2024
eCTD 3.2.2 new package available
A new version of the EU eCTD M1 Specification, version 3.1, is now published on the eSubmission website
The version 3.1 sees the introduction of a number of changes across the specification, however, more specifically, the introduction of a new annex detailing the list of accepted file formats
(Reminder: the generally accepted file format is the PDF, however, in specific cases, other formats will be exceptionally accepted in the eCTD modules). The changes are reflected in the Release Notes.
The same changes are reflected in the additional files of the EU M1 Implementation Guide package (i.e. eu-envelope.mod, eu-regional.dtd, eu-regional.xsl)
A new version of the validation criteria has been published on the eSubmission website. The version is related to the EU Module 1 Specification version 3.1 and should be used in case of submitting a new sequence according to EU M1 specification v3.1. The new validation criteria will be used for the technical validation for all v3.1 electronic submissions received as of 1 March 2025 to the NCAs and EMA. The changes are reflected in the Release Notes.
During the initial period of 6 months from 18 June 2024 to 30 November 2024, applicants can only submit eCTD format submissions compliant with EU M1 v3.0.4 and validation criteria version 7.1.
From 1 December 2024 eCTDs compliant with EU M1 v3.0.4 or v3.1 and validation criteria v7.1 or v8.0 are accepted.
From 1 March 2025 only eCTDs compliant with EU M1 v3.1 and validation criteria v8.0 are accepted.
13-06-2024
ICH Call for Vendor participation now open
A call for vendor participation is now published on the ICH Official website.
If you are an eCTD v4.0 Tool Vendor and would like to join the eCTD Tool Vendor Group to discuss eCTD v4.0 implementation, please send the following information listed below to ICHM8Vendors@ich.org:
- First Name;
- Last Name;
- Email;
- Company Name;
Please note that your information will be shared as needed with Representatives of ICH Members and Observers involved with ICH eCTD activities.
The Vendor Group kick-off meeting will be held on 17 July 2024, at 7.00 A.M. ET.
The vendor group is solely intended to facilitate collaborative discussion on the eCTD v4.0 Implementation Specification and timelines.
More information can be found on the ICH Official web site: ICH.
AND
ICH eCTD v4.0 package updated
The ICH eCTD v4.0 package has been updated in response to the change requests and/or discussion within the EWG after its initial release. There has been number of updates to the ICH IG and both the Support Documentation and the Orientation Material presentations have been updated. Additionally, as of May 2024, the Implementation Guide and Controlled Vocabulary documents were split into two different packages to enable Controlled Vocabulary Versioning.
More information can be found on the ICH Official web site: ICH.
11-06-2024
Planned maintenance of the PSUR Repository (NCAs only) on 18 June 2024, 18:00 CET
Due to planned maintenance, the PSUR Repository NCA UI and PSUR Repository NCA API will not be available for approximately 1 hour on Tuesday, 18 June 2024, after 18:00 CET. The maintenance is related to a technical upgrade and will not result in any changes of the features and functionalities of the system.
AND
Planned maintenance of the eSubmission systems on 19 June 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Wednesday, 19 June 2024, between 18:00 and 21:00:Common Repository Web-UI (relevant for NCAs only) and Common Repository API (relevant for NCAs only). During the same interval, the Gateway Filehandler will experience short delays in sending the acknowledgements of the processed submissions.
03-06-2024
PMS Product UI Now Live on the PLM Portal
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 (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 join the 3 June 2024 training session to prepare for registration & navigation of PUI.
17-05-2024
Updated PLM Portal Guide to Navigation is now available
Please find an updated version of the draft PLM Portal eAF Guide to Navigation here.
AND
New Paediatric submissions are mandatory via IRIS platform from 4 June 2024
Please note that from 4 June 2024, the following types of new paediatric submissions must be carried out via IRIS:
- Initial paediatric investigation plan (PIP)
- Modification of an agreed PIP
- Product-specific waiver
- Compliance check
- Annual report on paediatric deferred measures
- Confirmation of applicability of a class waiver, or inclusion of an indication within a condition
- Discontinuation of paediatric development.
To ensure a smooth transition to using the IRIS platform, it is essential that applicants prepare well in advance, including registering for IRIS, as described in the following document:
https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/iris-guide-registration-and-rpis_en.pdf
The gateway is open for ongoing paediatric procedures only.
15-05-2024
A new PLM Portal Home page
New, product specific tiles for electronic Product Information (ePI) and the Product Management Service (PMS) Product User Interface have been 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.
AND
Recommended use of web-based human variations eAF for all CAPs
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.
26-04-2024
Paediatric submissions to launch on IRIS platform from 4 June 2024
Please note that from 4 June 2024, the paediatric submissions must be carried out via IRIS. For more information please see the announcement.
24-04-2024
Register for the Information and Q&A session on updated CAPs in PLM Portal eAF, 7 May 2024
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.
23-04-2024
Successful CAPs data load under review, recommended use of interactive PDF extended
Updated Centrally Authorised Products (CAPs) data has been loaded to web-based (PLM Portal) eAF, where users will be able to see this data in their forms.
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.
19-04-2024
Updated VNeeS checker for v3.1.1 now available
An updated version of the VNeeS checker provided by Anses - ANMV is now available.
11-04-2024
Updated eAF v1.26.0.1 (Vet MAA) now available
An updated v1.26.0.1 Vet MAA eAF is now available on the eSubmission website.
A change has been implemented to fix a bug related to the navigation in the form after its finalisation.
It is recommended to use this latest form for new submissions. Please note that there is no version number change and that the release notes will be updated and published in the relevant section of the eAF page.
AND
electronic Application Forms (eAFs) not available for use between 11th and 16th April 2024 due to planned maintenance
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.
Please refer to the news published on 15 March 2024 for the complete details of the planned maintenance and we remind you that 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.
20-03-2024
Planned maintenance of the eSubmission systems on 25 March 2024, 18:00 CET
Due to planned maintenance, the following eSubmission systems will not be available on Monday 25 March 2024, between 18:00 and 21:00: Gateway XML delivery file user interface and Common Repository Web-UI (relevant for NCAs only).
The maintenance includes the introduction of a new field in the eSubmission Gateway XML delivery file user interface (EPITT number for pam-sda submissions), and other small bug fixes and improvements.
Previously created delivery files will not continue to work, please use the new version of the Gateway XML delivery file after the maintenance has completed.
Updated documentation will be published on the relevant pages of the eSubmission website.
For any further information, please contact EMA Service Desk.
15-03-2024
electronic Application Forms (eAFs) not available for use between 11th and 16th April 2024 due to planned maintenance
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:
- changes to product names;
- introduction of new medicinal products through splitting**;
- potential alterations to packages.
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
15-03-2024
Register for the eCTD v4.0 Vendor Workshop on 27 March 2024
The electronic Common Technical Document (eCTD) is the standard norm for industry submissions for over 20 years and currently implemented by regulators and industry in version 3.2.2. Version 4.0 of eCTD was published in December 2015 with its most recent Implementation Package v1.5 endorsed at the May 2022 ICH meeting.
This workshop, organised and facilitated by the eCTD v4.0 SME Group (EMA, NCAs and Industry), is intended for all eCTD Vendors that are interested in better understanding changes to the EU regional eCTD Specification. The event aims at fostering a discussion around the key sections of the new version of the Implementation Guide, the technical understanding of the implementation of the new standard, including the grouped submissions, document re-use and controlled vocabularies. At the moment, the focus will be on the Centralised Procedures only.
Moreover, during the workshop, the scope and timeline of the pilot, as well as the timeline for the updates of the Implementation Guide, will be discussed.
This session also offers an invaluable opportunity for participants to ask questions and provide feedback on pertinent matters.
Register for this workshop.
After registration you will receive a confirmation e-mail with the link and password to access the workshop. Please make sure to save those to be able to participate to the workshop.
15-03-2024
Planned maintenance of the Common Repository Torrent in the evening of 21 March 2024
Due to planned maintenance, the use of the Torrent files via client to download the content will not be possible on Thursday 21 March 2024, between 18:00 and 21:00. For any further information, please contact EMA Service Desk.
14-03-2024
eCTD v4.0 EU M1 Implementation Guide - draft Version 1.1 now available
A new draft version of the eCTD v4.0 EU M1 Implementation Guide is now available here for consultation. Future versions (together with EU Controlled Vocabularies and other annexes) will be published and announced on the eSubmission website.
29-02-2024
Updated eAF v1.26.0.1 (Vet MAA) now available
An updated v1.26.0.1 Vet MAA eAF is available starting with 29 February 2024, 18:00 CET.
A change has been implemented to add "United Kingdom (Northern Ireland)"" in the Member state selection in sections 2.4.1 and 2.4.4.
It is recommended to use this latest form for new submissions. Please note that there is no version number change and that the release notes will be updated and published in the relevant section of the eAF page.
For the UK, as from 1.1.2021, EU Law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland/NI.
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