eSubmission: Projects

Due to planned maintenance, the Common Repository Web User Interface (relevant for NCAs only) will not be available on Wednesday 9 July 2025, between 18:00 and 20:00.

The PLM portal FHIR XML version was updated to 2.2.3. The new version introduces the following changes:

• There’s a new extension in (sub)Task.code.coding[system=https://spor.ema.europa.eu/v1/lists/100000152091].extension[system=http://ema.europa.eu/fhir/termName].valueString containing the full name of the scope. For example: “B.II.e.7.a Deletion of a supplier”, instead of “B.II.e.7.a”
• The DataCarrierIdentifier identifier was moved from PackagedProductDefinition.package.identifier to PackagedProductDefinition.identifier

The Release notes can be found here.

The next upgrade of the PLM Portal FHIR XML (2.2.4) is currently planned for the end of July 2025, and the date will be confirmed in due time. The version 2.2.4 will introduce a change on the HTTP protocol of the links referenced in the FHIR message. The recommended FHIR protocol is HTTP, therefore all the links currently using HTTPS will be changed to HTTP.

The electronic Common Technical Document (eCTD) v4.0 team is pleased to launch Step 2 of the eCTD v4.0 Technical Pilot, for Centrally Authorised Products (CAP). Please note that the participation is very limited and the participants will be selected based on the readiness and compliance with the scenarios and focus described below.
We would like to invite interested MAHs to provide details of their proposed products, scenarios and very importantly the name of the eCTD v4.0 tool, by 15 July by email to eCTD4consultation@ema.europa.eu. Upon confirmation from EMA will send details on how the test packages can be submitted

Important notes

all the test submissions from Step 2 will be processed in an EMA Test environment and the submission channel will not be EMA Gateway
a first draft of the validation criteria will be published in the upcoming weeks, and the initial test submissions of Step 2 will not go through a “standard” validation

The main scenarios below will be followed, but please send your proposals for different/new scenarios when expressing your interest to participate:

Scenario 1. Initial MAA (sequence 1); EMA will prioritise for processing those MAHs who can resubmit sequence 1 for an existing/already authorised CAP (previously created in eCTD 3.2.2, sequence 0000, even if currently is not a valid product anymore), and now re-created/converted (fully or partially) in eCTD v4.0.

controlled vocabularies
different file formats
multiple pack sizes, manufacturers

Scenario 2. Initial MAA (sequence 1) for a Duplicate product sent in scenario 1 (the Duplicate product can be a mock product; this will facilitate early testing of Grouped submissions functionality, which is planned for Step 3)

Document reuse
different file formats

Scenario 3. Validation responses (starting with sequence 2), responses

Document lifecycle management (replace context of use (one to one, one to many and many to one), delete)
Updating keywords, priority numbers, and document titles
Regulatory activity (Submission and related sequences for 1 regulatory activity)

Scenario 4. Post authorisation activities (different procedure types and multiple sequences related to the products sent in sequence 1)

Document lifecycle management (replace context of use (one to one, one to many and many to one), delete)
Updating keywords, priority numbers, and document titles
Parallel regulatory activities

In Step 2 (the planned initial duration of this step is 2 months: 15 July – 15 September, subject to extension if necessary) of the eCTD v4.0 of the technical pilot there will be no focus on Grouped submissions functionality, forward compatibility. These will be tested in Step 3, planned for late Q3 2025.

Please note: all the communication will take place over email and depending on the number of test packages received and EMA eCTD v4.0 team availability, there might be a delay in the response time.

Training session on Human variations web-based electronic Application Form (eAF) for non-CAPs - 1 July 2025 10:00 - 11:30 Amsterdam time (CEST)

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. The details can be found on the event page.

Starting from end of May 2025 EMA recommends the use of the PLM Portal web-based eAF for all non-CAPs human variations, where possible. This training aims to support users with the adoption of the web-based eAF and to showcase new functionalities, user experience and user interface improvement.

An updated version of the Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.7 released to production on 23 June 2025 are now available on PLM Portal and on the PLM Portal eAF web page

An updated draft version of the PLM Portal eAF guide to navigation is now available. The guide to navigation contains part of the new UI/UX design, and more updates will be added in future versions of the guide.

An updated version of the Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.6 released to production on 10 June 2025 are now available on PLM Portal and on the PLM Portal eAF web page

Due to planned maintenance, the PSUR Repository (Industry access) will not be available today between 18:00 and 19:30. For any further information, please contact EMA Service Desk

Reminder: Due to planned maintenance, the PSUR Repository (Industry access) will not be functional during 20 - 22 June 2025. During this downtime, the PSUR packages that are submitted through the EMA gateway will not be processed. During the week 23 - 27 June 2025, the PSUR Repository and the PSUR submissions will be closely monitored, and even though all the potential scenarios were carefully considered, unforeseen disruptions could occur during this week. To avoid any delays in sending the PSUR packages, it is highly recommended to submit the packages a few days before the 20th of June 2025.
For further details, please follow the EMA Service Desk and eSubmissions.

Due to planned maintenance, the PSUR Repository (Industry access) will not be functional during 20 - 22 June 2025. During this downtime, the PSUR packages that are submitted through the EMA gateway will not be processed.
During the week 23 - 27 June 2025, the PSUR Repository and the PSUR submissions will be closely monitored, and even though all the potential scenarios were carefully considered, unforeseen disruptions could occur during this week.
To avoid any delays in sending the PSUR packages, it is highly recommended to submit the packages a few days before the 20th of June 2025.
For further details, please follow the EMA Service Desk and eSubmissions.

A new version of the EU eCTD M1 Specification, version 3.1.1 , is now published on the eSubmission website . The version 3.1.1 sees the introduction of a small number of changes in the specification, related to the tracking table for EDQM and new examples of product numbers and procedure numbers for work-sharing and super-grouping. The changes are reflected in the Release Notes .

A new version of the validation criteria v8.2 has been published on the eSubmission website. The version is related to the EU Module 1 Specification version 3.1.1 and should be used in case of submitting a new sequence according to EU M1 specification v3.1.1. The new validation criteria will be used for the technical validation for all v3.1.1 electronic submissions received as of 1 December 2025 to the NCAs and EMA. The changes are reflected in the Release Notes.

A new version of the Harmonised guidance eCTD 6.0.1 was published together with the new version of the specification and the validation criteria

During the initial period of 4 months from 2 June 2025 to 30 September 2025, applicants can only submit eCTD format submissions compliant with EU M1 v3.1 and validation criteria version 8.1.

From 1 October 2025 eCTDs compliant with EU M1 v3.1 or v3.1.1 and validation criteria v8.1 or v8.2 are accepted.

From 1 December 2025 only eCTDs compliant with EU M1 v3.1.1 and validation criteria v8.2 are accepted.

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.5 released to production on 26 May 2025 are now available on PLM Portal and on the PLM Portal eAF web page

Due to planned maintenance, the following eSubmission systems will not be available on Friday 23 May 2025, between 18:00 and 19:00: PSUR Repository (relevant for NCAs only).

Recommended use of web-based Human variations electronic Application Forms (eAFs) for non-CAPs

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. This is aligned with the timeline and the roadmap towards mandatory use of the PLM Portal web-based eAF for all human variations.

Please note that the interactive PDF eAF remains available for use for all variation procedures and while the PLM Portal eAF is now recommended for use for all procedure types, there are some technical limitations, and in these cases you might need to use the interactive pdf forms. Consult the guidance and the release notes.

Please report any production issues through the EMA ServiceDesk - Incident. Any change request or other generic questions, recommendations, improvement suggestions please raise them through EMA ServiceDesk - Request

PLM Portal web-based eAF use levels:
Optional Use: Both the interactive PDF and the web-based eAF are available. Applicants may choose either format, and no preference is expressed.
Recommended Use: The use of the web-based eAF is encouraged. However, applicants may continue to use the interactive PDF if they are not yet ready to adapt their internal processes.
Strongly Recommended Use: The web-based eAF should be used in most cases. The interactive PDF should only be used if specific constraints prevent the use of the web-based eAF (e.g., technical issues or missing features).
Mandatory Use: The use of the web-based eAF is required. Submissions using the interactive PDF will not be accepted. Mandatory use will only be introduced after a formally announced transition period.

* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.4 released to production on 13 May 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

Please note that a small number of products are affected by a synchronisation issue with PMS and the forms where they are used cannot be exported and finalised. Once added the products in the eAF, export the form and should you see the message "Data refresh cannot be completed. Aborting the operation. Please retry again", please use the interactive PDF instead. The teams are working on fixing this issue and a new message will be published once it is resolved.

Additionally, the PLM portal FHIR XML version was updated to 2.2.2. The new version introduces the following change: there is a new element in the Organisation, called "alias", which contains (if existing) the selected alternative company name: <alias value="alternative company/organisation name" />

eAF v1.27.0.1 (Human Variation, interactive PDF) now available, for use from 1 May 2025

A new version of the interactive PDF Human Variation eAF v.27.0.1 was published today, 6th of May 2025, bringing a small change in the exported XML data. No other changes are introduced. It is highly recommended to use this latest version of the form.

Reminder:
A new version of the Human Variation eAF v1.27.0.1 is now available on the eAF website. The version should be used starting with 1^st of May 2025. The version allows the selection of Reference Member State and Concerned Member State(s) when the type of authorisation is 'National Authorisation' and the type of application is 'Super-grouping'.

It is mandatory to use version 1.27.0.1 for all new Human Variation procedures. The version 1.27.0.0 for Human Variations will be removed from the eAF website, however, users can continue to submit applications using this version for ongoing procedures. Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.3 released to production on 28 April 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

Please note that a small number of products are affected by a synchronisation issue with PMS and the forms where they are used cannot be exported and finalised. Once added the products in the eAF, export the form and should you see the message "Data refresh cannot be completed. Aborting the operation. Please retry again", please use the interactive PDF instead. The teams are working on fixing this issue and a new message will be published once it is resolved.

Due to planned maintenance, the following eSubmission systems will not be available on Wednesday 30 April 2025, between 18:00 and 20:00: eSubmission website, PSUR Repository, Gateway Filehandler, Delivery File UI, Registration Gateway.

Reminder for PSUSA procedures: new requirement for Word version of the initial PSURs and RSI responses

When submitting initial PSUR or RSI responses for a PSUSA procedure, the marketing authorisation holders (MAHs) are also required to systematically provide Word versions of the submitted initial PSURs and RSI responses, as part of the Working Documents folder.

When submitted with an eCTD, the Working Documents should always be provided in a separate folder called "xxxx-workingdocuments" on the same submission zip package containing the eCTD, where the number (xxxx) matches the number of the eCTD sequence being submitted.

Any deviation will lead to a failed submission, and the package will have to be resubmitted with the correct naming. For example, if sending sequence "0007", which contains working documents, the separate folder should be named "0007-workingdocuments".

A new version of the Human Variation eAF v1.27.0.1 is now available on the eAF website. The version can be used starting with 1^st of May 2025. The version allows the selection of Reference Member State and Concerned Member State(s) when the type of authorisation is 'National Authorisation' and the type of application is 'Super-grouping'.

It is mandatory to use version 1.27.0.1 for all new Human Variation procedures. The version 1.27.0.0 for Human Variations will be removed from the eAF website, however, users can continue to submit applications using this version for ongoing procedures. Applicants are reminded that the version of the form should not be changed during an ongoing procedure.

PSUSA procedures: new requirement for Word version of the PSURs and RSI responses

When submitting PSUR or RSI responses for a PSUSA procedure, the marketing authorisation holders (MAHs) are also required to systematically provide Word versions of the submitted PSURs and RSI responses, as part of the Working Documents folder.

Reminder
When submitted with an eCTD, the Working Documents should always be provided in a separate folder called "xxxx-workingdocuments" on the same submission zip package containing the eCTD, where the number (xxxx) matches the number of the eCTD sequence being submitted.

Due to planned maintenance, the Common Repository Web User Interface and API (relevant for NCAs only) and the PSUR Repository Industry access and NCA access will not be available on Wednesday 23 April 2025, between 18:00 and 20:00. For any further information, please contact EMA Service Desk.

Update on web-based Human variations electronic Application Forms (eAFs) timeline

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.

During Q1 2025, we announced that the human variation web-based eAF was open for first use for non-Centrally Authorised Products (non-CAPs) through the PLM Portal, allowing Marketing Authorisation Holders to use the web-based application form for all EU variation procedures, including submission to the NCAs.

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.2 released to production on 31 March 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

In the most recent validation criteria (version 8.1) for EU eCTD M1 specification, the rules 15.11 and 15.12 referring to the tracking table being mandatory for all submission types were updated. However, these rules do not apply to EDQM submissions; a new version of the EU eCTD M1 package will be published at a later stage.

In the meantime, for EDQM submissions, you can submit the packages even if the validation does not pass for rules 15.11 and 15.12.

Due to planned maintenance and the activation of the Common Repository API MFA, the Common Repository Web User Interface and API (relevant for NCAs only) will not be available on Monday 31 March 2025, between 18:00 and 22:00.

Due to planned maintenance, the Common Repository Web User Interface and API (relevant for NCAs only) and PSUR Repository Web User Interface and API (relevant for NCAs only) will not be available on Monday 24 March 2025, between 18:00 and 22:00

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.1 released to production on 17 March 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.2.0.0 released to production on 06 March 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

Due to planned maintenance, the PSUR Repository API (relevant for NCAs only) will not be available on Friday 7 March 2025, between 18:00 and 19:00.

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 PLM portal FHIR XML version was updated to 2.2.1. The new version introduces the following change: the <meta> node will contain a new profile value (<profile value=http://ema.europa.eu/fhir/definition/fhir-export/2.2.1.0 />) and the "Bundle-variation" will lose the 4th digit in the XML.

Due to planned maintenance, improvements in the Delivery File User Interface and for the Multi Factor Authentication go-live in Common Repository (relevant for NCAs only) and PSUR Repository (relevant for NCAs only), the following eSubmission systems will not be available on Tuesday 4 March 2025, between 18:00 and 22:00: Common Repository (Web User Interface and API), PSUR Repository (Web User Interface and API), Gateway Filehandler, Delivery File User Interface.

Due to planned maintenance and in preparation to the MFA activation, the following eSubmission systems will not be available on Thursday 27 February 2025, between 18:00 and 22:00: Common Repository Web User Interface and Common Repository API (both applicable for NCAs only).

Planned maintenance of PSUR Repository (Industry access) on 28 January 2025, 18:00 CET

Due to planned maintenance, the PSUR Repository (Industry access) will not be available on Friday 28 February 2025, between 18:00 and 20:00.

An updated version of the PLM Portal eAF Release Notes reflecting bug fixes and updates to web eAF made in the version 1.1.1.4 released to production on 18 February 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

As of 29 January 2025, the European Shortages Monitoring Platform (ESMP) is fully operational . In addition to the routine shortage reporting by marketing authorisation holders (MAHs) of centrally authorised products (CAPs), launched in November 2024, the full scope of functionalities of the ESMP is available for crisis and MSSG-led preparedness reporting, for both MAHs and national competent authorities (NCAs). These newly released functionalities will be active in ESMP in crises and preparedness situations for affected MAHs of CAPs and non-CAPs according to the list of medicines published for the specific situations.

The ESMP will enable information exchange for prevention, identification and management of shortages to ensure medicines are available for patients in the EU and EEA.

A dedicated training session for all MAHs will be held on 19 February 2025 from 10:00-12:30 CET. Registration is available here (MAH training registration - WebEx) and more information is available on the training event page on EMA's corporate website. The session will be live broadcast and a recording will be published on the event page.

Further, EMA organises a Q&A session for CAP MAHs on the routine CAP shortage reporting functionalities on 25 February 2025, 10:00 - 11:00 CET. Find more information here on the Q&A clinic (event page) and registration is available via this link (Q&A for CAP MAHs - WebEx). The session will be recorded, and the recording will be made available on the event page.

Finally, please note that all relevant and continuously updated ESMP materials can be found on the ESMP webpage on the EMA website.

Production go-live for submissions of human variations web-based eAFs for non-CAPs

As previously announced through our Product Lifecycle Management (PLM) newsletter (27/01/2025) 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.

Please note that the interactive PDF eAF remains available for use for all variation procedures and while the PLM Portal eAF is now available for use for all procedure types, there are some technical limitations, and in these cases the applicants are requested to use the interactive pdf forms.

* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.1.1.3 released to production on 3 February 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

The PLM portal FHIR XML version was updated to 2.2.0, however no change affecting the web-based eAF XML was introduced. The Release notes can be found here.

Due to planned maintenance, the Common Repository (User interface and API) will not be available on Wednesday 5 February 2025, between 18:00 and 20:00. For any further information, please contact EMA Service Desk.

The Product Management Service (PMS) User Interface (PUI) edit functionalities - live on the Product Lifecycle Management (PLM) portal - are now available for Industry users.

Note that the write access is for now limited to pack size and manufacturer data for non-Centrally Authorised Products* (non-CAPs). This data is indeed required for the shortage reporting via the European Shortages Monitoring Platform (ESMP), which went live with full functionalities on 29 January 2025.

Please consult this news article for full PMS roadmap and a recap of key current and future actions for MAHs.

* Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP)

The Human Variation form v1.27.0.0 was updated on the 29 January 2025. The change follows the recent update of the new variation regulation; in the Declaration section in the parallel procedures sub-section, the table with the product/procedure details has been removed.

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.

An updated version of the PLM Portal eAF Release notes reflecting bug fixes and updates to web eAF made in the version 1.1.1.2 released to production on 20 January 2025 are now available on PLM Portal and on the PLM Portal eAF web page.

In the most recent validation criteria (version 8.1) for EU eCTD M1 specification, the rules 15.11 and 15.12 referring to the tracking table being mandatory for all submission types were updated. However, these rules do not apply to EDQM submissions, and therefore a further communication and potential update of the EU eCTD M1 package will be published. In the meantime, for EDQM submissions, you can use the previous validation criteria package (7.1).

An updated version of the EU eCTD v4.0 Controlled Vocabularies is now available here. The updated package contains the missing list (territorial authority) and the unused list was removed (dosage form category).

Due to planned maintenance, the following eSubmission systems will not be available on Tuesday 14 January 2025, between 18:00 and 19:30: Gateway XML delivery file user interface, Gateway Filehandler, PSUR Repository Web-UI. For any further information, please contact EMA service desk.