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Introduction

To facilitate the submission of regulatory information concerning marketing authorisations application for medicinal products to National Competent Authorities and EMA as well as to streamline the business process, standards for electronic submissions have been developed.

For human medicinal products, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) developed an electronic exchange standard called electronic Common Technical Document (eCTD). This standard is based on “M4: The Common Technical Document (CTD)” in its various parts.

The current electronic version was developed by the eCTD Implementation Working Group and released as version 3.2 in February 2004. The European Union applies the eCTD Specification in the European region and has completed it with the European Module 1.

Preparation of the next major version (version 4.0) is now ongoing within the ICH.

For more information, please refer to the eCTD v.3.2, eCTD EU M1 specification and eCTD v.4.0 webpages.

For veterinary medicinal products, a specific EU standard, Veterinary Non-eCTD electronic Submissions (VNeeS), that is based on the EU Notice to Applicants format for veterinary applications, has been developed.
For more information, please refer to the Veterinary eSubmission webpage.

The EU standards and related guidance documents are developed and maintained by the different key user groups and approved by the eSubmission expert group before publication.

For technical support, visit the EMA Service Desk portal using your user credentials for a system hosted by EMA (except Eudravigilance). If you do not have an account or have forgotten your credentials, please click here.

For details on how to find us please click here.

eSubmission eAFRSS news feed

Previous news is available here

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What's New in eSubmission Today?

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17-11-2022

Updated PLM Portal Guide to eAF (DADI) Registration is now available

An updated version of the Portal (eAF) guide to registration is now available on PLM Portal eAF (DADI) webpage. The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. This update includes further details on the use of Multi Factor Authentication (MFA).

Following the release, users of the Human Variations eAF should expect continual work on improvements in the form of regular releases. These will be a mix of bug fixes, scheduled improvements, improvements based on user acceptance testing (UAT) feedback or that may be identified by users after the release and new features, such as additional structured data fields.

For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal. Please share any questions with us via eSubProgofficer@ema.europa.eu.

04-11-2022

Web-based Human Variations eAF (DADI) now live on the new Product Lifecycle Management Portal

EMA is pleased to announce the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) is now available on the new Product Lifecycle Management (PLM) Portal. This is a big, first milestone in the ongoing journey to improve the eAFs and related processes. EMA has been collaborating with the UNICOM consortium to develop the human variation form and other web-based forms.

Following the release, users of the Human Variations eAF should expect continual work on improvements in the form of regular releases. These will be a mix of bug fixes, scheduled improvements, improvements based on user acceptance testing (UAT) feedback or that may be identified by users after the release and new features, such as additional structured data fields.

As a reminder: the use of the new web-based form is optional. This release will not trigger a transition period towards mandatory use. The formal transition period will start when nationally authorised products (NAPs) and features supporting use cases covered will be added to the form. The current interactive PDF eAF will remain available until the end of the transition period.

The new PLM Portal will in due course host all eAFs. In the future it will also host the data input user interface for product management service (PMS) data and the interface to provide data for for electronic Product Information (ePI). The PLM Portal will develop over time to inform and support you in the use of these services. One new feature launched on the PLM portal is a chatbot through which you can ask questions about the web-forms and get quick answers.

More information on upcoming events and resources available to help users to get familiar with the new form and the new PLM Portal is available here.

31-10-2022

Updated Product Lifecycle Management Portal Guide to (DADI) eAF Registration is now available

An updated version of the PLM Portal (eAF) guide to registration is now available on PLM Portal eAF (DADI). The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the PLM Portal. Most of these steps are independent from the PLM Portal eAF and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems. Applicants are invited to register for the new PLM Portal with the support of this updated guide.

You will be able to sign into the portal after the go-live of the Human Variations electronic Application form (eAF) for CAPs.

For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal. Please share any questions with us via eSubProgofficer@ema.europa.eu.

26-10-2022

eSubmission Gateway XML delivery file update for Raw Data submissions

An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file (addition of new submission type for 'Raw data submission' (human domain only). Further information on the Raw data pilot submissions can be found here. Please note that this new submission type should only be used when it has been previously agreed that the product is taking part in the pilot. The details on the changes are provided in the related release notes which are available here and the updated user guide is available here.

Previously created delivery files should continue to work, however, it is always recommended to clear the cookies and the cache to ensure that the system works correctly.

eCTD EU Module 1 Specification now open for review and all stakeholders are invited to submit change requests on the specification - deadline extended until 1st November 2022

The Human Harmonisation Group has decided to open the eCTD EU Module 1 Specification for review and all stakeholders are invited to review the list of submitted change requests and, to submit new change requests on the specification.
Please find a list of submitted change requests and the template to submit any new change requests to the current version of the eCTD EU M1 specification. The comments should be submitted via email to EUM1Spec@ema.europa.eu by end of the day 1st of November 2022.

14-10-2022

Updated version of the eAF v1.26.0.0 (human variation) now available

An updated version 1.26.0.0 of the human variation eAFs is now available here. A single change has been implemented to emphasize the mandatory use of OMS for centralised procedure by updating the Declaration label in the Proposed section. There is a very limited impact to users of the forms. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human).

Please note that an updated EMA practical guidance on the eAF for Type IA and IB variations is now available and this updated version of the guide addresses the use of this important declaration.

It is strongly recommended to use this latest version (document properties date 3.10.2022). Please note that there is no version number change. Please note that the release notes are not published for this minor change at this time.

Web-based Human Variations eAF go-live details

EMA is pleased to inform that the web-based Human Variations electronic application form (eAF) for CAPs – often referred to by its former project name: DADI - will be available for use on 4 November 2022 on the new Product Lifecycle Management (PLM) Portal. EMA has been collaborating with the UNICOM consortium to develop the new web-form. To ensure full technical and business support services at go-live, release to the public is scheduled slightly later than the original target date of 31 October. This is due to European Holidays on November 1 and 2.

Following the release, users of the Human Variations eAF should expect continual work on improvements in the form of regular releases. These will be a mix of scheduled improvements, improvements based on user acceptance testing (UAT) feedback or that may be identified by users after the release and new features, such as additional structured data fields. Going live as scheduled and continually improving the form is the most effective route to having a high performing web-form in the shortest timeframe and it is in accordance with an Agile way of working.

As a reminder: this release will not trigger a transition period towards mandatory use. The formal transition period will start after the anticipated March 2023 release when nationally authorised products (NAPs) features will be also added to the form. The interactive PDF eAF will remain available until the end of the transition period.

The new PLM Portal will in due course host all web based eAFs, data input user interface for product management service (PMS) data and the interface to provide data for electronic Product Information (ePI). You can expect reference to Digital Application Dataset Integration (DADI) to be phased out over the coming weeks in favour of eAF and the PLM Portal.

We have the following resources to help you get familiar with the new form and the new environment:
  • Pre go-live:
    • Publication of the updated guides for portal registration and navigation (to be made available via the eSubmission website).
    • Human Variations Form go-live Q&A session: 27 October 2022 (14:00-15:00), Registration link.
  • Post go-live:
  • Please note an updated general Q&A document, including Q&A’s on PMS, and a training Q&A document addressing questions raised during earlier eAF trainings are now available. Please share any questions with us at eSubProgofficer@ema.europa.eu

    27-09-2022

    DADI Project Update

    System demo: digital application dataset integration (DADI) and Product Management Service (PMS) - Live broadcast available

    EMA has announced the 3rd public system demo of 2022. In this system demo, EMA will demonstrate developments of DADI project and the PMS service as well as other ongoing projects. The system demo will take place on Wednesday 28th September 2022 at 09:00-12:30 (CET). This demo will be presented via live broadcast to ensure that all interested colleagues are able to attend the session.

    No registration is required to follow the live broadcast on EMA's website, available from the event page. Kindly note the session will also be recorded and made available through EMA Corporate Website.

    Please share any questions on the above system demo with us at eSubProgofficer@ema.europa.eu.

    Update of the DADI Q&A document

    The DADI and PMS teams are pleased to announce that a joint DADI and PMS Q&A Document is now available here. Given their interdependencies, this updated version of Q&A document includes questions related to both DADI and PMS.

    Human variations form updated timeline

    Please find the September 2022 version of the DADI Human Variations Forms timeline, outlining the updated DADI BETA UAT timeframe. The UAT has started on 19th September and will end on the 30th September 2022.

    Recordings and documentation from the DADI training webinars held on 2nd September and on 26 July 2022 and Q&A webinar on the go-live held on 12th July 2022 now available

    The recording and the presentation from the DADI training webinar on 2nd September 2022 are now available and the recording from the training webinar held on 26th July 2022 is available here. The recording from the Q&A on go-live held on 12th July is also now available.

    eCTD EU Module 1 Specification now open for review and all stakeholders are invited to submit change requests on the specification

    The Human Harmonisation Group has decided to open the eCTD EU Module 1 Specification for review and all stakeholders are invited to review the list of submitted change requests and, to submit new change requests on the specification.
    Please find a list of submitted change requests and the template to submit any new change requests to the current version of the eCTD EU M1 specification. The comments should be submitted via email to EUM1Spec@ema.europa.eu by end of the day 25th of October 2022.

    02-08-2022

    Questions and Answers document from the public webinar “DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live” held on 12th July 2022

    The Q&A document from the public webinar is now available.

    27-07-2022

    The 1st DADI newsletter has been published on the EMA website

    The digital application dataset integration (DADI) newsletter, published four times a year, provides pharmaceutical companies and the national competent authorities (NCAs) in the EU updates on the progress of the DADI project.

    You can find the first issue of the newsletter here.

    Presentation from the public webinar “DADI Q&A Webinar - Variations form for Human Medicinal Products Go-live” held on 12th July 2022

    The presentation from the public webinar is now available.

    14-07-2022

    DADI eAF Portal Guide to Registration now available

    The Digital Application Dataset Integration (DADI) Network project team is pleased to announce the publication of the first version of the eAF Portal guide to registration on the DADI website.

    The guide aims to support the users of the eAF Portal in completing the registration steps before accessing the platform. Most of these steps are independent from the eAF Portal and correspond to those to obtain registration to use other European Medicines Agency (EMA) systems, such as Management Services for Substances, Products, Organisation and Referentials (SPOR).

    For any issues or technical support with EMA's IT systems, please raise a ticket with the EMA Service Desk portal.

    Invitation to register to the DADI eAF Training and Q&A webinars

    The Digital Application Dataset Integration (DADI) Network project will replace PDF electronic application forms (eAF) used for regulatory submissions with web-forms, making the future form-filling and submission-handling process more efficient.

    The variations form for Human medicinal products will be the first form to be released by DADI in October 2022. To effectively support stakeholders ahead of the go-live date, EMA is pleased to announce two new public eAF training and Q&A webinars.
    • 1st eAF training and Q&A webinar: 26 July 2022, 11:00-12:30 Central European Time (CET) - Registration link
    • 2nd eAF training and Q&A webinar: 2 September 2022, 11:00-12:30 Central European Time (CET) - Registration link
    These events are training webinars for industry and national competent authorities' stakeholders wishing to learn more about access management aspects related to the new portal and the procedure to fill in a web-based eAF at go-live.

    During the sessions, a demonstration focused on access management and the User Interface will be performed in order to showcase how to register and access the Portal, how to fill in the web-based eAF, select products and export the forms.
    Kindly note recordings from both training sessions will be made available after each event.
    Please share your questions on the above webinar with us at eSubProgofficer@ema.europa.eu.

    Recordings and documentation from the DADI public webinar held on 16th May and the System Demo held on 28th June 2022 now available

    The recording from the DADI public webinar on go-live and the Quarterly system demo (Q2 2022) are now available here for the 16th May and here for the 28th of June 2022. Documentations for the webinars are also available here.

    11-07-2022

    eSubmission Gateway Web Client - upgraded Syncplicity portal now in production

    The eSubmission Web Client portal has now been upgraded to Axway Syncplicity portal. Please access the new Web Client to send submissions to the EMA here.

    All previously registered eSubmission Gateway Web Client users should have now received an email from Axway with a link to reset your password for the production Web Client. Please see the Guidance on how to reset your password.

    07-07-2022

    DADI Human Variations eAF User Acceptance Testing (UAT) - Call for Volunteers

    In the context of the digitalisation of the Variations Application Form for Human Medicinal Products, the EMA is pleased to invite Applicants to participate in the UAT of the Digital Application Dataset Integration (DADI) Network project.

    UAT timeline and scope

    The DADI UAT is planned to be conducted between 5th and 16th September 2022. During that period, the production-like version of the electronic Application Forms (eAF) Portal will be open for testing. As recently communicated, please note that the scope of this UAT is limited to Centrally Authorised Products (CAPs). The UAT participants are expected to perform testing activities, by filling in electronic Application Forms as close as possible to real-life scenarios. Namely, this implies filling in an eAF for one or multiple CAPs, single scope or grouping of scopes from different variation procedure types (e.g., type IA or type IB), and to export the PDF output to be included in a submission.

    More information and how to register can be here.

    05-07-2022

    eSubmission Gateway Web Client upgrade - Syncplicity go-live for production environment on this weekend (8th - 10th July 2022)

    As previously published, the EMA is in the process of upgrading our current Axway Gateway solution.
    Please note that migration of all users in the Production System will be done this weekend, starting from Friday, 8 July 2022, at 17:00 CEST until Sunday, 10 July 2022, at 18:00 CEST. Should this need to be postponed, an update will be published on this webpage.

    Please note that registered production environment users will receive an email from Axway Syncplicity with a link to reset your password for the production environment. Please see the guidance on how to reset your password.

    In the view of the update for Gateway to Gateway users only, we have requested you to make the required changes to update your firewall rules in line with the gateway connections document. If you use the Gateway-to-Gateway connection (not relevant to Web Client users), please implement the required changes by Friday, 8 July 2022, at 17:00 CEST to avoid any business disruption.

    DADI Human Variations eAF revised go-live scope

    EMA will launch the eAF variations web form in October 2022. This is a first release of the web-based variation form for human medicinal products that will be improved and expanded in subsequent releases in 2023. This progressive release model follows the Agile development model of the Agency.

    The scope of the October 2022 go-live will be limited to Centrally Authorised Products (CAPs). EMA made this decision due to the complexity in synchronisation of the data between xEVMPD and PMS.
    A subsequent release of the form in March 2023 will support all types of EU variation procedures (CAPs and NAPs).

    More information is available here.

    15-06-2022

    eSubmission Gateway Web Client upgrade - External UAT for all XCOMP users now open

    The issues relating to preparations for the external UAT have been solved and all eSubmission Web Client XCOMP users are now invited to start user acceptance testing (XCOMP environment). Please refer to the Guidance on how to submit using Syncplicity Web Client.

    The migration of all existing XCOMP environment users to Syncplicity was done on Wednesday 8th of June 2022 - previously registered XCOMP users have received an email from Axway Syncplicity with a link to reset password for the XCOMP (test) environment. Please note that this resetting of the password has no impact in the password in production eSubmission Gateway Web Client. Please see the guidance on how to reset your password.

    There is no need to register for the UAT. Please provide any feedback via the EMA Service Desk as soon as possible, but latest by Wednesday 22nd June 2022.

    It is currently anticipated by Axway that the go-live of the new Web Client (Syncplicity) will be in take place in late June 2022. Date is yet to be confirmed. Before the go-live in production, the 'sun Java' which is only available in Internet Explorer is still required.

    14-06-2022

    A new version of the eSubmission Gateway XML delivery file is now available

    An updated version of the eSubmission Gateway XML delivery file user interface is now available here. The new version provides an update of the framework for the delivery file user interface for both, the eSubmission Gateway delivery file UI and the PSUR Repository UI. The update is mainly technical, providing a slightly different look and feel. Additionally, 2 new submission types; Companion Diagnostics Consultation and Follow-up Companion Diagnostics consultation have been added into the Gateway Delivery file UI human domain. No other functional changes have been introduced in the user interface.

    Release notes and an updated user guide are available here.

    A new version of the PSUR Repository Industry UI (xml delivery file UI) is now available

    An updated version of the PSUR Repository Industry UI (xml delivery file user interface) is now available here. The new version provides an update of the framework for the delivery file user interface the PSUR Repository UI. The update is mainly technical, providing a slightly different look and feel.

    Additionally, the only technical change is to limit the submission format to eCTD which was done in the view of the mandatory use of eCTD since January 2019.

    Release notes and an updated user guide are available here.

    Updated versions of the eAF v1.26.0.0 (bug fix version) now available

    Updated versions 1.26.0.0 of the human and veterinary variation eAFs are now available here.
    The changes implemented in this version are business rule corrections only, relating to mandatory use of OMS for centralised procedure and business rule in section 4b Paediatrics in the human variation form. There is a very limited impact to users of the forms. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human) and 28th January 2022 (veterinary).

    It is strongly recommended to use this latest version (document properties date 30.05.2022).
    Please note that there is no version number change.

    More details can be found from the release notes available here.

    10-06-2022

    eSubmission Gateway Web Client upgrade - Migration of all (XCOMP) users to Syncplicity ongoing

    The issues relating to preparations for the external UAT have been solved and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days (XCOMP environment). Please note that internal testing is still ongoing, and it is recommended that external testers do not start testing yet.

    The migration of all existing XCOMP environment users to Syncplicity was done on Wednesday 8th of June 2022 - please note that registered XCOMP users have received an email from Axway Syncplicity with a link to reset your password for the XCOMP (test) environment. Please note that this resetting of the password has no impact in the password in production eSubmission Gateway Web Client. Please see the guidance on how to reset your password.

    The details on how to send test submissions will be published as soon as the user guide becomes available once the migration activities have been finalised.

    There is no need to register for the UAT, and the link to the system will be provided via this website.

    It is currently anticipated by Axway that the go-live of the new Web Client (Syncplicity) will be in take place in late June. Date is yet to be confirmed. Until then, the 'sun Java' is still required (only available in IE).

    eSubmission Gateway Delivery file UI and the PSUR Repository MAH user interface - technical update go-live postponed until Tuesday 14th June 2022

    The eSubmissions and the PSUR Repository team has been working on an update of the framework for the delivery file user interfaces for both the eSubmission Gateway delivery file UI and the PSUR Repository UI.

    These updates are mainly a technical updates only providing a slightly different look and feel. Additionally, 2 new submission types; Companion Diagnostics Consultation and Follow-up Companion Diagnostics consultation have been added in to the Gateway Delivery file UI. There are no other functional changes to the MAH user interface.

    This updated user interface will be deployed in production on 14th of June 2022.

    Updated versions of the eAF v1.26.0.0 (bug fix version) will be released on Tuesday 14th June 2022

    Updated versions 1.26.0.0 of the human and veterinary variation eAFs will be released on the eAF website on Tuesday 14th June 2022.
    The changes implemented in this version are business rule corrections only, relating to mandatory use of OMS for centralised procedure and business rule in section 4b Paediatrics in the human variation form. There is a very limited impact to users of the forms. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human) and 28th January 2022 (veterinary).

    It is strongly recommended to use this latest version (document properties date 30.05.2022). Please note that there is no version number change.

    More details can be found from the release notes available here.

    08-06-2022

    DADI Conceptual Data Models now available

    Updated FHIR mapping now available

    The updated excel sheet listing all fields in the Variation and Medicinal Product has been published on the DADI website on the 23rd of May. The Conceptual Data Models for the human variation form FHIR message and the medicinal product in a variation FHIR message are now also available on the DADI website.
    The example of the FHIR message is available on the EU Network website only (due to commercially confidential data).

    For any questions, please contact the DADI project team via via the EMA Service Desk. (Please select option “Ask a question” and including in the subject “DADI Q&A”).

    eSubmission Gateway Web Client upgrade

    The EMA is in the process of upgrading our current Axway Gateway solution.
    The Gateway tool provider Axway is currently facing some issues with the new tool, however it is expected that the testing by external users can start within next couple of days.
    Details and updated user guide will be published to support testing.

    eSubmission Gateway Delivery file UI - technical update go-live 10th June 2022

    The eSubmissions team has been working on an update of the framework for the delivery file user interface. This is mainly a technical update only providing a slightly different look and feel. Additionally, 2 new submission types; Companion Diagnostics Consultation and Follow-up Companion Diagnostics consultation have been added. There are no other functional changes to the MAH user interface.

    This updated user interface will be deployed in production on 10th of June 2022.

    PSUR Repository MAH user interface - technical update go-live 10th June 2022

    The PSUR Repository team has been working on an update of the framework for the user interface. This is a technical update only providing a slightly different look and feel, however, there are no major functional changes to the MAH user interface.
    This updated user interface will be deployed in production on 10th of June 2022.

    24-05-2022

    DADI Project Update

    Human variations forms updated timeline & revised go-live scope

    Following the news published in February 2022 on the updated timeline for the release of DADI web-based variations forms for Human medicinal products further details on the timeline leading to go-live and go-live scope are now available here.

    Updated FHIR mapping now available

    An updated excel sheet listing all fields in the Variation form and the Medicinal Product is now available here. The FHIR messages relating to the latest mapping will be published on the EU Network website and once all confidential data has been redacted, they will also be published on the DADI website (timing TBC).

    For any questions, please contact the DADI project team via via the EMA Service Desk. (Please select option “Ask a question” and including in the subject “DADI Q&A”).

    Presentation from the public webinar “Variations Form for Human Medicinal Products - What will happen at Go-Live” held on 16th May 2022

    The presentation from the public webinar is now available.

    eSubmission Gateway Web Client upgrade

    The EMA is in the process of upgrading the current Axway Gateway solution.
    The Gateway tool provider Axway is currently facing some issues with the tool and this has caused a delay in the start of the User Acceptance Testing (UAT). Once these Syncplicity issues are resolved, Axway will propose a new timeline for the UAT and a date will be announced for the go-live in production.

    Update of IP addresses for Gateway to Gateway connections

    As part of an upcoming eSubmission Gateway upgrade which affects the Gateway to Gateway submission, the EMA will be changing the IP addresses of the AS2 Gateway connections. To ensure smooth transition, all current eSubmission Gateway to Gateway users are advised to update firewall rules in line with the gateway connections document. No other configuration changes are required as part of this upgrade.
    This IP address range change does not affect the Web Client users.

    If you have any questions on the upgrade, contact us using the EMA Service Desk.

    eSubmission Gateway Delivery file UI - technical update

    The eSubmissions team has been working on an update of the framework for the delivery file user interface. This is mainly a technical update only providing a slightly different look and feel. Additionally, 2 new submission types; Companion Diagnostics Consultation and Follow-up Companion Diagnostics consultation have been added. There are no other functional changes to the MAH user interface.

    The updated user interface will be deployed in production once the internal user acceptance testing has been finalised (exact date TBC).

    An updated user guide and release notes will be published at the time of the go live.

    PSUR Repository MAH user interface - technical update

    The PSUR Repository team has been working on an update of the framework for the user interface. This is a technical update only providing a slightly different look and feel. It should also be noted that the option to select submission format NeeS has been disabled in the view of mandatory use of eCTD for all procedure types since 1st January 2019. There are no other functional changes to the MAH user interface.
    The updated user interface will be deployed in production once the internal user acceptance testing has been finalised (exact date TBC).

    An updated user guide and release notes will be published at the time of the go live.

    28-04-2022

    Invitation to register to DADI-PMS Webinar - “Variations Form for Human Medicinal Products - What will happen at Go-Live”, 16/05/22 h. 10:00-12:00 (CET)

    EMA is pleased to announce a new public webinar on the Digital Application Dataset Integration (DADI) Network Project Human Variations web-form go-live and its interaction with Product Management Service (PMS). The event will take place on 16 May 2022 at 10:00-12:00 Central European Time (CET).

    More details are available here.

    DADI-PMS Webinar Agenda - Variations Form for Human Medicinal Products - What will happen at Go-Live

    26-04-2022

    Updated versions of the eAF v1.26.0.0 (bug fix version) now available

    Updated versions 1.26.0.0 of all eAFs are now available on the eAF website here. An updated human and veterinary MAA forms, Variation forms and the updated Renewal form are ready for immediate use. The changes implemented in this version are bug fixes and business rule corrections only and there is a limited impact to users. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human) and 28th January 2022 (veterinary).
    It is strongly recommended to use this latest version (document properties date 26.04.2022). Please note that there is no version number change.

    More details can be found from the release notes available here.

    21-04-2022

    eSubmission Gateway Web Client upgrade - Migration of all (XCOMP) users to Syncplicity starting now

    The preparations for the external UAT are almost finalised and it is now expected that the eSubmission Web Client users can start the user acceptance testing within the next couple of days (XCOMP environment). The link to the test system and details on how to send test submissions will be published as soon as they become available.

    There is no need to register for the UAT, and the link to the system will be provided via this website.

    The migration of all existing XCOMP environment users to Syncplicity starting today - please note that you will be receiving an email from Axway Syncplicity with a link to reset your password for the XCOMP (test) environment. This resetting of the password has no impact in the password in production eSubmission Gateway Web Client.

    The vgateway (old XCOMP environment) is currently not accessible.

    The new Web Client (Axway Syncplicity) will be implemented in production environment in May 2022 following successful user acceptance testing.

    Clarification on Variations Not Requiring Assessment (VNRA) availability in the Common Repository (vet domain)

    Variations Not Requiring Assessment (VNRAs) are procedures only dealt with within the Union Product Database (UPD), without involvement of the rapporteurs. However, to continue to have a complete overview of a product life cycle including all post-authorisation procedures, VNRAs for Centrally Authorised Products will also be available in the Common repository, for reference only.

    Updated General FAQ relating to eSubmission for Veterinary Applications is now available

    The General FAQ relating to eSubmission for Veterinary Applications has been updated and is now available here.

    A draft eCTD v4.0 implementation timeline

    A draft timeline for the implementation of eCTD v4.0 in the EU was published in the ICH website in January 2022. This draft timeline is now also available on the eCTD v4.0 page here.

    31-03-2022

    Recordings from the DADI public webinars held on 18th and 25th January 2022 now available

    The recordings from both DADI public webinars held in January are now available here for the 18th and here for the 25th of January 2022.

    31-03-2022

    Updated versions of the eAF v1.26.0.0 (bug fix version) now available

    Updated versions 1.26.0.0 eAFs are now available on the eAF website here. An updated human and veterinary MAA forms, Renewal form and veterinary variation form are ready for immediate use. The changes implemented in this version are minor bug fixes only and they do not affect most users. The use of the v1.26.0.0 is mandatory since 1st January 2022 (human) and 28th January 2022 (veterinary) and the users can select if they wish to continue using the previously published version or the updated version (there is no version number change or any changes to the Data Exchange Standard (DES)).

    More details can be found from the release notes available here.

    Updated version of the eSubmission Gateway error codes document now available

    An updated version of the eSubmission Gateway Error codes document is now available here.
    The error codes document is useful to find out more details on why your submission via the eSubmission Gateway has failed.

    eSubmission Gateway Web Client upgrade - UAT planned for April 2022

    The EMA eSubmission team is pleased to announce that a project to upgrade the eSubmission Gateway Web Client is ongoing and the updated version of the Web Client (Axway Syncplicity) will be implemented in May 2022 subject to successful user acceptance testing planned to take place in April 2022.
    More details and the call for volunteers to take part in the UAT will be published soon.

    10-03-2022

    Digital Application Dataset Integration (DADI) Network Project Technical Webinar (FHIR) 25/01/2022 - Presentation and the FHIR mapping and examples now available

    Please find the presentation and the FHIR mapping & examples the webinar on "Common factors in the Fast Healthcare Interoperability Resources (FHIR) data standard for Art57(2) and eAF" in the following link. Please note that the recording from the webinar will be published as soon as it becomes available.

    And

    System demo: digital application dataset integration (DADI) and Product Management Service (PMS) - Live broadcast available

    EMA has announced the first public system demo of 2022. In this system demo, EMA will demonstrate developments of DADI project and the PMS service. The system demo will take place on Tuesday 15 March 2022 at 09:00-11:00 (CET). As the original WebEx webinar has reached maximum registration, the EMA team is pleased to inform you that a live broadcast will be available on the day to allow additional interested colleagues to attend the session.

    No registration is required to follow the live broadcast on EMA's website, available from the event page. Kindly note the session will also be recorded and made available through EMA Corporate Website.

    Please share any questions on the above system demo with us at eSubProgofficer@ema.europa.eu.

    And

    eSubmission Gateway Web Client upgrade planned for Spring 2022

    The EMA eSubmission team is pleased to announce that a project to upgrade the eSubmission Gateway Web Client is ongoing and the updated version of the Web Client (Axway Syncplicity) will be implemented in May 2022 subject to successful user acceptance testing planned to take place in April 2022.

    This upgrade will result in need for an update of the user passwords to allow access to the updated system. Further details participation in the UAT and on the steps required from existing users will be published in advance of the change.

    17-02-2022

    DADI Project updated Questions and Answers document now available

    The Digital Application Dataset Integration (DADI) Network Project team is pleased to announce that an updated version of the DADI Questions and Answers documents is now available here.

    For general inquiries, please contact the DADI project team via eSubProgofficer@ema.europa.eu. For questions or comments around the content of this Q&A document, please raise a ticket (by selecting “Ask a question” and including in the subject “DADI Q&A”) via the EMA service desk.
    If you have a technical question about the DADI project, please raise a ticket (by selecting “Ask a question” and including in the subject “DADI”) via the EMA service desk.

    Reminder on the mandatory use of OMS in Centralised Procedure

    The use of Organisation Management Service (OMS) data became mandatory for Centrally Authorised Product applications as of 1st November 2021.
    Since then, Centralised Procedure application submissions not using OMS data, are being filtered out during EMA validation and sent back to the applicant for remedial action. For applicants and Marketing Authorisation Holders, remedial action includes populating data in the application form before resubmitting the updated application form. In addition, it may mean registering or enriching OMS data to make it available for use in the form.
    Although most of the free text address fields in eAFs have been removed for Centralised Procedure applications, the EMA has noted that some applicants are still not registering their organisation data in OMS and/or are misusing the “proposed” section of the Variation form. Please note that it is very important to make use of the 'address' part of the 'proposed' field for the organisation addresses. The address details should not (in most cases) be included in the'free text' field for proposed.

    It is important to update OMS first and then select the 'updated' OMS information in 'proposed' field, the 'present' field can, in cases where the OMS entry has been updated, be filled in manually.

    In order to avoid the risk of delaying the processing of their applications EMA urges applicants to: follow the instructions provided in Questions and Answers about OMS, register OMS data, i.e. organisational information, in advance of any forthcoming application submissions consider the turnaround time for OMS change request processing when planning to submit applications.

    If you have any questions on the use of OMS in general or use of OMS in the eAFs, please contact us using the EMA service desk.

    11-02-2022

    Technical issue on the eAF webpage affecting availability of the latest versions of the eAF v1.26.0.0 has been fixed

    The updated versions 1.26.0.0 eAFs (Veterinary MAA and variation, human variation) were published on the eAF website on 20th of January 2022.
    A technical issue has been identified which means that these latest versions were replaced by earlier versions (at some point around 5th of February). The issue has been now fixed and the latest version of the forms are now again available, but please note that if you have downloaded/used an eAF from the eAF website recently, please check the document properties to ensure that you are using the correct, latest version dated 17/01/2022.
    For any issues with the eAFs, or any issues in relation to the VMP-Reg, please raise a call via the EMA service desk.

    04-02-2022

    DADI Project Update - Updated timeline for the release of Human variations forms

    Following the announcement on the revised timeline made during the first Digital Application Dataset Integration (DADI) Network Project public webinar held on 18 January 2022, an updated timeline for the release of DADI web-based variations forms for Human medicinal products, including key milestones, is now available here.

    And

    Presentation from the first DADI public webinar held on 18 January 2022 now published

    Please find the presentation from the webinar available at the following link. Please note that the recording from the webinar will be published as soon as it becomes available.

    28-01-2022

    Veterinary Medicinal Products Regulation (Regulation (EU 2019/6) enters into force – updated eSubmission systems/forms now available for mandatory use

    eAF

    The use of the updated version of 1.26.0.0 eAFs is now mandatory for all new veterinary variations and marketing authorisation applications. Please note that there is no transitional period and the v1.25.0.0 cannot be used for any new procedures starting after 28th January 2022.

    The version 1.25.0.0 has now been removed from the website, however, it should be noted that the version of the form should not be changed during an ongoing procedure. This also applies to the veterinary procedures which have started prior to 28th of January 2022.

    eSubmission Gateway XML delivery file

    An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a large number of changes to the delivery files for Veterinary submissions reflecting the requirements/changes from the VMP-Reg (e.g. addition of new submission types, removal of submission types/submission units that are no longer relevant, update of available business units in relation to submission types for which no 'new applications' can be made once the new legislation is in force and addition of new values for Submission format dropdown menu).

    More details can be found from the release notes and the technical documentation available here.

    Users should note that the delivery files created prior to the new release will not work after the go live.

    Common Repository (NCAs only)

    An updated version of the Common Repository User interface is now available. This new version reflects changes introduced by the VMP-Reg (addition of new cabinets for VAMF and VPTMF)

    20-01-2022

    Updated versions of the eAF v1.26.0.0 now available

    Updated versions 1.26.0.0 eAFs are now available on the eAF website. An updated human variation form is ready for immediate use. The change implemented in this version is a minor business rule change only and it will not affect most users. The use of the v1.26.0.0 is mandatory since 1st January 2022 and the users can select if they wish to continue using the previously published version or the updated version.

    Updated forms for veterinary applications are available for applicants and MAHs to familiarise themselves with the updated forms prior to the mandatory use of this version for veterinary submissions from 28th of January 2022. Please note that there will be no transitional period once these forms go-live on the 28th of January. The v1.25.0.0 cannot be used for any new procedures starting after 28th January 2022.

    The main changes in this updated version of the veterinary forms (maa and variation) relate to the implementation of the Regulation (EU) 2019/6 for Veterinary Medicinal Products and the changes are those that were previously indicated as known issues in the release notes and other issues that were raised during the UAT and other issues that have been discovered by users since the publication of the forms on the 1st of December 2021.

    The version 1.26.0.0 cannot be used for procedures prior to 28th January 2022, however, in the view of significant changes in the forms it is strongly recommended that applicants will carefully review the updated forms (maa and variation) prior to the mandatory use deadline in order to identify and report any issues in the implementation and thus allowing an opportunity to fix any issues found prior to 28th January 2022. The version 1.25.0.0 will remain available for use for veterinary procedures (maa and variation) until the mandatory use of v1.26.0.0

    More details can be found from the release notes and the technical documentation available here.

    Applicants are reminded that the version of the form should not be changed during an ongoing procedure. This also applies to the veterinary procedures which have started prior to 28th of January 2022, it is important to note that the version of the form must not be changed during an ongoing procedure.

    For any issues with the eAFs, or any issues in relation to the VMP-Reg, please raise a call via the EMA service desk.

    18-01-2022

    A new version of the eSubmission Gateway XML delivery file is now available

    An updated version of the eSubmission Gateway XML delivery file user interface is now available. This update has introduced a small change to the delivery file (addition of new submission description 'Raw data pilot submission' for MAA 'additional information' (human domain only). Further information on the Raw data pilot submissions will be published soon and this new submission description should only be used when it has been previously agreed that the product is taking part in the pilot. The details on the changes are provided in the related release notes which are available here and the updated user guide is available here.

    Previously created delivery files should continue to work, however, it is always recommended to clear the cookies and the cache to ensure that the system works correctly.

    14-01-2022

    Digital Application Dataset Integration (DADI) Network Project Webinar 18/01/2022 - Live broadcast available

    In a previous news published on 10 December 2021 EMA announced the upcoming webinar ”Introducing DADI: The Digital Application Dataset Integration Network Project to replace electronic application forms” on 18 January 2022 at 10:30-12:00 Central European Time (CET). As the original WebEx webinar has reached maximum registration, the DADI Network Project team is pleased to inform you that a live broadcast will be available on the day to allow additional interested colleagues to attend the session. The updated guidance enters into force 1st February 2022.

    No registration is required to follow the live broadcast on EMA's website available from the event page and from EMA's broadcasting channel

    At certain points throughout this session, participants will be able to ask questions and give their input via the audience interaction tool Slido. Interaction via Slido is voluntary, and you may opt to remain anonymous. If you choose to use Slido, you consent to the processing of your personal data as explained in the EMA Data Privacy Statement for Slido

    Kindly note the session will also be recorded and made available through EMA Corporate Website.

    Thank you for forwarding this message to your affiliated Members who wish to participate.

    Please share any questions on the above webinar with us at eSubProgofficer@ema.europa.eu.

    22-12-2021

    Updated EU Harmonised technical eCTD guidance now available

    An updated version of the EU Harmonised technical eCTD guidance and the related release notes are now available here. The updated guidance enters into force 1st February 2022.

    And

    Final, updated Veterinary eSubmission Guideline and other relevant veterinary eSubmission documents are now available

    An updated version of the Veterinary eSubmission Guideline and other relevant veterinary eSubmission documents updated to reflect the VMP-Reg are now available here.

    And

    The EMA is closed 23 December 2021 to 3 January 2022 inclusive.

    The EMA IT service desk closes at 18:30 (CET) on 22 December 2021.
    A skeleton service will be available on 23rd, 27th, 28th, 29th, 30th and 31st (half day) December 2021, as well as on 3rd January 2022.
    Please note that if the queries are complex or require specific expertise they may not be resolved until the service desk returns to normal service on 4 January 2022.

    There will be no regulatory procedural support available during the EMA office closure.

    We would like to advise to send all planned in December submission in timely manner considering limited availability of IT service desk during upcoming Christmas holiday.

    10-12-2021

    Invitation to register to the Digital Application Dataset Integration (DADI) Network Project Webinars

    The Digital Application Dataset Integration (DADI) Network Project to replace electronic application forms is pleased to announce it's first public webinars which will take place on 18 January 2022, h. 10:30-12:00 Central European Time (CET) and on 25 January 2022, h. 10:30-12:00 Central European Time (CET).

    Read more details here.

    01-12-2021

    eAF v1.26.0.0 now available

    New version 1.26.0.0 of all eAFs is now available on the eAF website. The forms for human applications (maa, variation and renewal) are ready for immediate use. The use of the v1.26.0.0 for human procedures becomes mandatory after a short one-month transitional period on 1st January 2022. The version v1.25.0.0 of the human forms has been removed from the eAF website, however users can continue to submit applications using this version until the end of December 2021.

    The main change in this version of the forms for human use relate to the mandatory use of OMS for Centralised Procedure applications. This version of the forms removes the free text fields in the forms when EU authorisation/Centralised Procedure is selected. Additionally, a bug fix relating to Medical Device section in the variation form has been provided.

    The forms for veterinary applications are available for applicants and MAHs to familiarise with the updated forms prior to the mandatory use of this version for veterinary submissions from 28th of January 2022. Please note that there will be no transitional period once these forms go-live on the 28th of January. The v1.25.0.0 cannot be used for any new procedures starting after 28th January 2022.

    The main changes in this version of the veterinary forms (maa and variation) relate to the implementation of the Regulation (EU) 2019/6 for Veterinary Medicinal Products.

    The version 1.26.0.0 cannot be used for procedures prior to 28th January 2022, however, in the view of significant changes in the forms it is strongly recommended that applicants will carefully review the form prior to the mandatory use deadline in order to identify and report any issues in the implementation and thus allowing an opportunity to fix any issues found prior to 28th January 2022.
    The version 1.25.0.0 will remain available for use for veterinary procedures (maa and variation) until the mandatory use of v1.26.0.0.

    More details can be found from the release notes and the technical documentation available here.

    Applicants are reminded that the version of the form should not be changed during an ongoing procedure. This also applies to the veterinary procedures which have started prior to 28th of January 2022, it is important to note that the version of the form must not be changed during an ongoing procedure.

    For any issues with the eAFs, or any issues in relation to the VMP-Reg, please raise a call via the EMA service desk.

    11-11-2021

    Essential maintenance to PSUR and eSubmission Gateway

    Please note that PSUR and eSubmission Gateway File Handler will be unavailable from Friday 12/11/2021 after 18:00, until Monday 15/11/2021 morning 8:00, due to essential maintenance. EMA gateway will, however, remain available for all communities throughout and any files submitted during that time will be queued for processing when the work is complete.

    If you have any questions, please contact the IT service desk.

    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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