07 March 2025
Purpose and Context
EMA is pleased to announce the web-based Human Variations electronic application form (eAF) for Centrally Authorised Products (CAPs) has gone live on 4th November 2022, on the new Product Lifecycle Management (PLM) Portal. This is a big, first, milestone in the ongoing journey to improve the eAF and related processes. EMA has been collaborating with the UNICOM consortium to develop the human variation form and other new web-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.
Following a successful updated product load in April 2024, the use of the web-based eAF is now strongly recommended for all Centralised Procedure variation applications (where possible). Please note that small number of limitations still exists in the system, however, the use of the web-based form should start becoming the first option and the use of the interactive pdf should be only in cases where the use of the web-based form is not yet possible/feasible in the view of limitations.
The eAF team is pleased to announce that the PLM Portal web based eAFs can be used for all EU products and procedures starting from 11 February 2025. Please follow user guidance, the current release notes and EMA announcements in relation to any known technical limitations.
The formal transition period will start when nationally authorised products (NAPs) and features supporting all use cases covered by the interactive pdf eAF 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 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.
This document lists and briefly describes the new features and fixed issues included in the release of the PLM Portal.
The most recent release appears first.
About this document
This document lists and briefly describes the new features and fixed issues included in each release of the PLM Portal.
The most recent release appears first.
The known issues are categorised per component or business process of the system so that users can easily identify which issues are relevant for them. The components currently used are:
Component | Short Description |
PLM Portal | This component relates to the website, the UI (user interface) |
Human Variations eAF | The business process where MAH’s create and edit their variation eAF (electronic application form) on the PLM Portal |
The PDF that is available for download after the completion of an application | |
FHIR XML | The FHIR xml file attached to exported PDF |
For additional information on the PLM portal see this:
- If you encounter any issue that is not addressed by the above, visit the EMA Service Desk portal: https://support.ema.europa.eu/esc
- For more general information, please visit: https://esubmission.ema.europa.eu/cessp/cessp.htm
Version: 1.2.0.0 (Release date 06/03/2025)
Version Goal: Integrity Stamp, Proof of payment improvements
Date: 06/03/2025
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.2.0.0 | This release note is for the version 1.2.0.0 release go-live 06/03/2025 |
New stories released in this version
| ID | Description | Comments |
| 219351 | Integrity Stamp | The integrity stamp was deployed to production.
|
| 233025 234197 | Proof of payment improvements | The experience of the user with the proof of payment section was improved by separating the Yes/No options for the proof of payment and by applying several performance enhancements |
Coming soon/we are currently working on
| ID | Short description |
| Various | Performance improvements e.g. Finalisation section – implementation postponed |
| 210325 | Present and Proposed section re-design and performance improvements implementation of the remaining features/functions. Expected deployment: Q1 2025 |
| Various | Analysis of the next set of structured changes e.g. ATC code, Medical Device |
Known Issues and Limitations
| ID | Short description |
| 230186 | The ATC code added in the Present and Proposed using the ATC code popup is not completely functional, and the display in the PDF is not correct. Any changes in the ATC code must be done in the standard Present and Proposed boxes |
| 185709 | Allow the selection of an ‘Alternative’ organisation name in the eAF (displayed on the pdf) |
| Known issue | When exporting the pdf, the export is intermittently not triggered on the first attempt but might require multiple attempts before succeeding. |
| Known issue | Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD. |
| Known issue | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known issue | In Medical Device section the ‘EU authorised representative’ option is missing Workaround: use the interactive pdf eAF for variations where section 4d needs to be filled in |
| Known issue | The selections from the Medical Device section 4d. are not correctly reflected in the pdf export in some cases. Please note: for variation applications indicating a change in the device in section 4d. please consider using the interactive pdf eAF. |
| Known issue | Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish |
| Known issue | Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German |
| Known issue | In section Type(s) of Change(s) – scope selection: known issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided. |
| Known limitation | 23965 - Conditions and documentation are presented in different order from the variation classification guideline |
| Known limitation | Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss. |
| Known limitation | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted – will be resolved with the new present and proposed design |
| Known limitation | 22845 – Deletion of Application Form is not yet available |
| Known limitation | 23545 - Performance issues Number of sections take very long to open or to display the changes/selections made by the user; for example in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc. |
| Known limitation | 23963 - Finalisation: Annexed document and Declaration Section are presented in random order |
Version: 1.1.1.4 (Release date 18/02/2025)
Version Goal: Proof of payment improvements, Product selection improvement, Bug fixes
Date: 18/02/2025
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.1.1.4 | This release note is for the version 1.1.1.4 release go-live 18/02/2025 |
New stories released in this version
| ID | Description | Comments |
| 226938 | Product selection: search product number of rows | In the product selection page, the number of rows can not be changed to 500 entries. Other minor improvements were implemented on this page |
| 226666 | Proposed changes | Improvements were implemented for the auto-save of the information added in the present-proposed and a prompt to ask the user if the changes should be saved |
| 233162 | Procedural information | The member state in the contact person window is now mandatory |
| 231898 | Finalisation | A bug related to the printing twice of the additional signatory was fixed |
| 229986 | NCA access – Authorisation status | In the View available products window, the NCA users can now see the autrhorisation status |
| 229531 | Procedural information – Contact person | A bug related to adding maximum one contact person for a form with CAPs only was fixed |
| 234220 | Finalisation – Proof of payment | Fixes were made in the Proof of Payment section related to the appearance in various scenarios of the Member states |
| 234062 | Bug fix - Additional Information: RO Form shows section failed after submission | A bug related to the “Additional information” section appearing only after finalising the form and marked as “Incomplete” (the form becomes “RO” (Read-Only)) was fixed |
Coming soon/we are currently working on
| ID | Short description |
| Various | Performance improvements e.g. Finalisation section – implementation postponed |
| 210325 | Present and Proposed section re-design and performance improvements implementation of the remaining features/functions. Expected deployment: Q1 2025 |
| 219351 Development finalised – pending production deployment | eAF integrity stamp: Upon Finalising the application form, a digital signature confirming that the form has been exported from the PLM Portal is placed on the pdf export by the system. Important note: The integrity stamp is a digital signature which is placed in the pdf export automatically by the system when the application form is Finalised. It is planned that once this feature is rolled out, it will become mandatory to ‘Finalise’ the forms meaning that if an eAF is submitted without the stamp it is likely to lead to rejection of the form and request to resubmit with a ‘Finalised’ form. Please note that it is possible to include an additional, company specific ‘Digital signature’ in the exported, Finalised eAF pdf form after the automated system integrity stamp has been added. Other types of signatures, such as image of a signature and adobe signature cannot be included in the form after the integrity stamp has been added by the system. Expected deployment: Q1 2025 |
| Various | Analysis of the next set of structured changes e.g. ATC code, Medical Device |
Known Issues and Limitations
| ID | Short description |
| 230186 | The ATC code added in the Present and Proposed using the ATC code popup is not completely functional, and the display in the PDF is not correct. Any changes in the ATC code must be done in the standard Present and Proposed boxes |
| 185709 | Allow the selection of an ‘Alternative’ organisation name in the eAF (displayed on the pdf) |
| Known issue | When exporting the pdf, the export is intermittently not triggered on the first attempt but might require multiple attempts before succeeding. |
| Known issue | Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD. |
| Known issue | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known issue | In Medical Device section the ‘EU authorised representative’ option is missing Workaround: use the interactive pdf eAF for variations where section 4d needs to be filled in |
| Known issue | The selections from the Medical Device section 4d. are not correctly reflected in the pdf export in some cases. Please note: for variation applications indicating a change in the device in section 4d. please consider using the interactive pdf eAF. |
| Known issue | Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish |
| Known issue | Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German |
| Known issue | In section Type(s) of Change(s) – scope selection: known issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided. |
| Known limitation | 23965 - Conditions and documentation are presented in different order from the variation classification guideline |
| Known limitation | Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss. |
| Known limitation | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted – will be resolved with the new present and proposed design |
| Known limitation | 22845 – Deletion of Application Form is not yet available |
| Known limitation | 23545 - Performance issues Number of sections take very long to open or to display the changes/selections made by the user; for example in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc. |
| Known limitation | 23963 - Finalisation: Annexed document and Declaration Section are presented in random order |
Version: 1.1.1.3 (Release date 03/02/2025)
Version Goal: Proof of payment
Date: 03/02/2025
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.1.1.3 | This release note is for the version 1.1.1.3 release go-live 03/02/2025 |
New stories released in this version
| ID | Description | Comments |
| 207009 | Proof of Payment section: business rules fixes and non-CAP procedure support It is now possible to indicate different payment details for variations for countries with pre-payment and countries with billing details | For CAP only variations where procedure type is Type I, the proof of payment section is now hidden. For EMA led mixed CAP/MRP/DCP application, it is now possible to indicate payment details for the relevant member states. Please note that the value European Union should not be selected for Type I variations. Known issues/limitations: Variations containing products authorised through National authorisation (NP) and with a mix of CAPs and NP products, it is currently not possible to use the form. |
| 228315 | Declaration section: Hide the parallel procedures product grid in all possible scenarios | The grid where the details of the product(s) and procedure(s) is no longer required and has been removed for all procedures. |
| 229531 | Procedural information: Contact for applications with CAPs | A bug related to the contact person for CAPs was fixed (only one contact person can be added for the EU) |
| 230961 | Proposed Changes: Create/Edit modal should display Filter, not a search | In the proposed changes, the filter box now shows “Filter” instead of “Search” |
Coming soon/we are currently working on
| ID | Short description |
| Important note to all PLM Portal users | Due to an identified issue with ingredient data on the PLM Portal, the following medicinal product were removed from the Product Lifecycle Management Portal from 13 to 17 January 2025: all ingredients and their strengths, Pharmaceutical products and routes of administration, Package Items, Package Item Materials, Package Manufactured Items, ATC codes. From 20 January 2025, the removed data was re-uploaded in phases and all Centrally Authorised Products’ (CAPs) data and non-CAPs is now available. |
| Various | Performance improvements e.g. Finalisation section – implementation postponed |
| 210325 | Present and Proposed section re-design and performance improvements implementation of the remaining features/functions. Expected deployment: Q1 2025 |
| 219351 Development finalised – pending production deployment | eAF integrity stamp: Upon Finalising the application form, a digital signature confirming that the form has been exported from the PLM Portal is placed on the pdf export by the system. Important note: The integrity stamp is a digital signature which is placed in the pdf export automatically by the system when the application form is Finalised. It is planned that once this feature is rolled out, it will become mandatory to ‘Finalise’ the forms meaning that if an eAF is submitted without the stamp it is likely to lead to rejection of the form and request to resubmit with a ‘Finalised’ form. Please note that it is possible to include an additional, company specific ‘Digital signature’ in the exported, Finalised eAF pdf form after the automated system integrity stamp has been added. Other types of signatures, such as image of a signature and adobe signature cannot be included in the form after the integrity stamp has been added by the system. Expected deployment: Q1 2025 |
| Various | Analysis of the next set of structured changes e.g. ATC code, Medical Device |
Known Issues and Limitations
| ID | Short description |
| 230186 | The ATC code added in the Present and Proposed using the ATC code popup is not completely functional, and the display in the PDF is not correct. Any changes in the ATC code must be done in the standard Present and Proposed boxes |
| 185709 | Allow the selection of an ‘Alternative’ organisation name in the eAF (displayed on the pdf) |
| Known issue | When exporting the pdf, the export is intermittently not triggered on the first attempt but might require multiple attempts before succeeding. |
| Known issue | Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD. |
| Known issue | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known issue | In Medical Device section the ‘EU authorised representative’ option is missing Workaround: use the interactive pdf eAF for variations where section 4d needs to be filled in |
| Known issue | The selections from the Medical Device section 4d. are not correctly reflected in the pdf export in some cases. Please note: for variation applications indicating a change in the device in section 4d. please consider using the interactive pdf eAF. |
| Known issue | Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish |
| Known issue | Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German |
| Known issue | In section Type(s) of Change(s) – scope selection: known issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided. |
| Known limitation | 23965 - Conditions and documentation are presented in different order from the variation classification guideline |
| Known limitation | Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss. |
| Known limitation | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted – will be resolved with the new present and proposed design |
| Known limitation | 22845 – Deletion of Application Form is not yet available |
| Known limitation | 23545 - Performance issues Number of sections take very long to open or to display the changes/selections made by the user; for example in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc. |
| Known limitation | 23963 - Finalisation: Annexed document and Declaration Section are presented in random order |
Version: 1.1.1.2 (Release date 20/01/2025)
Version Goal: Updated present and proposed section
Date: 20/01/2025
Environment: production
Version content (testable functionalities/use cases)
Version content
New stories released in this version
Coming soon/we are currently working on
Known Issues and Limitations
Date: 20/01/2025
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.1.1.2 | This release note is for the version 1.1.1.2 release go-live 20/01/2025 |
New stories released in this version
| ID | Description | Comments |
| 228208 230244 230245 230256 230754 | Present and proposed improvements/bug fixes | Improvements and bugs in the Present and Proposed section were deployed:
|
Coming soon/we are currently working on
| ID | Short description |
| Important note to all PLM Portal users | Due to an identified issue with ingredient data on the PLM Portal, the following medicinal product data will be removed from the Product Lifecycle Management Portal from 13 to 17 January 2025:
In practice, for PLM Portal web-based eAF users this means that fields containing this information will be empty in the eAFs generated from the PLM Portal during this period. The missing data is not expected to impact the users of the eAF for variations for Centrally Authorised Products; and eAFs submitted with empty fields where the data is ‘missing’ due to the data cleansing exercise will not be rejected. We kindly request you not to report missing data/data issues in the eAF via the EMA Service desk during this period. This means that PLM Portal eAF users should be able to continue to use the web-based form during this period unless unexpected issues, that were not found during testing, are found once the data cleansing process starts. However, users should note that the interactive pdf eAF is available for use for all variation procedures and applicants may feel more comfortable using the pdf eAF. From 20 January 2025, the removed data will be re-uploaded in phases:
|
| Various | Performance improvements e.g. Finalisation section – implementation postponed |
| 207009 | Proof of Payment section: business rules fixes and non-CAP procedure support It is currently not possible to indicate different details for non-CAP WS variations for countries with pre-payment and countries with billing details Expected deployment: Q1 2025 |
| 210325 | Present and Proposed section re-design and performance improvements implementation of the remaining features/functions. Expected deployment: Q1 2025 |
| 219351 Development finalised – pending production deployment | eAF integrity stamp: Upon Finalising the application form, a digital signature confirming that the form has been exported from the PLM Portal is placed on the pdf export by the system. Important note: The integrity stamp is a digital signature which is placed in the pdf export automatically by the system when the application form is Finalised. It is planned that once this feature is rolled out, it will become mandatory to ‘Finalise’ the forms meaning that if an eAF is submitted without the stamp it is likely to lead to rejection of the form and request to resubmit with a ‘Finalised’ form. Please note that it is possible to include an additional, company specific ‘Digital signature’ in the exported, Finalised eAF pdf form after the automated system integrity stamp has been added. Other types of signatures, such as image of a signature and adobe signature cannot be included in the form after the integrity stamp has been added by the system. Expected deployment: Q1 2025 |
| Various | Analysis of the next set of structured changes e.g. ATC code, Medical Device |
Known Issues and Limitations
| ID | Short description |
| 230186 | The ATC code added in the Present and Proposed using the ATC code popup is not completely functional, and the display in the PDF is not correct. Any changes in the ATC code must be done in the standard Present and Proposed boxes |
| 185709 | Allow the selection of an ‘Alternative’ organisation name in the eAF (displayed on the pdf) |
| Known issue | When exporting the pdf, the export is intermittently not triggered on the first attempt but might require multiple attempts before succeeding. |
| Known issue | Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD. |
| Known issue | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known issue | In Medical Device section the ‘EU authorised representative’ option is missing Workaround: use the interactive pdf eAF for variations where section 4d needs to be filled in |
| Known issue | The selections from the Medical Device section 4d. are not correctly reflected in the pdf export in some cases. Please note: for variation applications indicating a change in the device in section 4d. please consider using the interactive pdf eAF. |
| Known issue | Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish |
| Known issue | Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German |
| Known issue | In section Type(s) of Change(s) – scope selection: known issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided. |
| Known limitation | 23965 - Conditions and documentation are presented in different order from the variation classification guideline |
| Known limitation | Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss. |
| Known limitation | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted – will be resolved with the new present and proposed design |
| Known limitation | 22845 – Deletion of Application Form is not yet available |
| Known limitation | 23545 - Performance issues Number of sections take very long to open or to display the changes/selections made by the user; for example in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc. |
| Known limitation | 23963 - Finalisation: Annexed document and Declaration Section are presented in random order |
Version: 1.1.1.1 (Release date 07/01/2025)
Version Goal: Updated present and proposed section, further variation regulation updates, multiselect application contact person and bug fixes
Date: 07/01/2025
Environment: production
Version content (testable functionalities/use cases)
Version content
New stories released in this version
Coming soon/we are currently working on
Known Issues and Limitations
Date: 07/01/2025
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.1.1.1 | This release note is for the version 1.1.1.1 release go-live 07/01/2025 |
New stories released in this version
| ID | Description | Comments |
| 227233 | Export: User cannot export and gets error ‘Data refresh cannot be completed’ | A bug related to pdf export has been fixed. Please note that if you experience issues with ‘Export’ function, please try to repeat the ‘Export’. It is possible that up to 3 or 4 attempts are needed before the export is triggered in some cases. |
| 228697 | Procedural Information: User not able to save the ‘Application form Contact person’ details | A bug related to saving application form contact person has been fixed. It is now possible to add and save the contact person details in the form. Known issue: Due to a bug the system allows users to add multiple contact persons for applications containing CAPs however, the validation rule preventing adding multiple contact persons is in place, but not visible. If you are getting a persistent error when ‘Finalising’ the form and the error points to Procedural Information section, please ensure that you have included only 1 application contact person for applications containing at least 1 Centrally Authorised Product. |
| Bugs: 227076 225964 226673 223452 226154 (to address bugs implemented in: 210325) | Present and Proposed section – Implement new functionality | Partial implementation of the improved Present and Proposed section with new User Interface (UX) designs. This is fixing the known issue/bug:
|
| 229512 | Finalisation: PDF – the text included in the Notes box is not displayed in the exported pdf | The text included in the Notes field in the parallel procedures section is now displayed in the pdf export of the eAF |
| 226690 | Finalisation: Parallel variations section label updated | The section header (label) has been updated to reflect the business requirement: Declaration of the application about the submission(s) of the same variation (or group of variations) in other Member States / EMA |
| 224122 | Product selection: only 5 product fields are shown in View selected products view | A bug in the table displaying selected products has been fixed and all selected products are now displayed (pagination available where list exceeds number of rows on the page) |
| 205988 | Product selection: the product search is not working properly (filter for authorised dose form) | A bug in the product selection with filter ‘authorised dose form’ has been fixed |
Coming soon/we are currently working on
| ID | Short description |
| Important note to all PLM Portal users | Due to an identified issue with ingredient data on the PLM Portal, the following medicinal product data will be removed from the Product Lifecycle Management Portal from 13 to 17 January 2025:
In practice, for PLM Portal web-based eAF users this means that fields containing this information will be empty in the eAFs generated from the PLM Portal during this period. The missing data is not expected to impact the users of the eAF for variations for Centrally Authorised Products; and eAFs submitted with empty fields where the data is ‘missing’ due to the data cleansing exercise will not be rejected. We kindly request you not to report missing data/data issues in the eAF via the EMA Service desk during this period. This means that PLM Portal eAF users should be able to continue to use the web-based form during this period unless unexpected issues, that were not found during testing, are found once the data cleansing process starts. However, users should note that the interactive pdf eAF is available for use for all variation procedures and applicants may feel more comfortable using the pdf eAF. From 20 January 2025, the removed data will be re-uploaded in phases:
|
| Various | Performance improvements e.g. Finalisation section – implementation postponed |
| 207009 | Proof of Payment section: business rules fixes and non-CAP procedure support It is currently not possible to indicate different details for non-CAP WS variations for countries with pre-payment and countries with billing details Expected deployment: Q1 2025 |
| 210325 | Present and Proposed section re-design and performance improvements implementation of the remaining features/functions. Expected deployment: Q1 2025 |
| 219351 Development finalised – pending production deployment | eAF integrity stamp: Upon Finalising the application form, a digital signature confirming that the form has been exported from the PLM Portal is placed on the pdf export by the system. Important note: The integrity stamp is a digital signature which is placed in the pdf export automatically by the system when the application form is Finalised. It is planned that once this feature is rolled out, it will become mandatory to ‘Finalise’ the forms meaning that if an eAF is submitted without the stamp it is likely to lead to rejection of the form and request to resubmit with a ‘Finalised’ form. Please note that it is possible to include an additional, company specific ‘Digital signature’ in the exported, Finalised eAF pdf form after the automated system integrity stamp has been added. Other types of signatures, such as image of a signature and adobe signature cannot be included in the form after the integrity stamp has been added by the system. Expected deployment: Q1 2025 |
| Various | Analysis of the next set of structured changes e.g. ATC code, Medical Device |
Known Issues and Limitations
| ID | Short description |
| 185709 | Allow the selection of an ‘Alternative’ organisation name in the eAF (displayed on the pdf) |
| Known issue | When exporting the pdf, the export is intermittently not triggered on the first attempt but might require multiple attempts before succeeding. |
| Known issue | Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD. |
| Known issue | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known issue | In Medical Device section the ‘EU authorised representative’ option is missing Workaround: use the interactive pdf eAF for variations where section 4d needs to be filled in |
| Known issue | The selections from the Medical Device section 4d. are not correctly reflected in the pdf export in some cases. Please note: for variation applications indicating a change in the device in section 4d. please consider using the interactive pdf eAF. |
| Known issue | Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish |
| Known issue | Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German |
| Known issue | In section Type(s) of Change(s) – scope selection: known issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided. |
| Known limitation | 23965 - Conditions and documentation are presented in different order from the variation classification guideline |
| Known limitation | Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss. |
| Known limitation | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted – will be resolved with the new present and proposed design |
| Known limitation | 22845 – Deletion of Application Form is not yet available |
| Known limitation | 23545 - Performance issues Number of sections take very long to open or to display the changes/selections made by the user; for example in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc. |
| Known limitation | 23963 - Finalisation: Annexed document and Declaration Section are presented in random order |
Version: 1.1.1.0 (Release date 09/12/2024)
Version Goal: Updated present and proposed section, further variation regulation updates, multiselect application contact person and bug fixes
Date: 09/12/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
New stories released in this version
Coming soon/we are currently working on
Known Issues and Limitations
Date: 09/12/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.1.1.0 | This release note is for the version 1.1.1.0 release go-live 09/12/2024 |
New stories released in this version
| ID | Description | Comments |
| 222840 | Procedural information: Change in calculation for type of application (for CAPs) | The business rules related to the calculation of type of application have been updated to correctly reflect single/grouping/workharing/super-grouping |
| 210325 | Present and Proposed section – Implement new functionality | Partial implementation of the improved Present and Proposed section with new User Interface (UX) designs Known issues and bugs:
|
| 173444 | Application Contact ‘Member State’ multi-selection for non-CAPs | For non-CAP variations it is now possible to indicate the same application contact person using new multiselect option for member state |
| 217411 | Updates related to ‘Parallel Procedures’ section/other changes reflecting amended variation regulation (e.g. mandatory worksharing) | The business rules have been updated and the Declaration on parallel variations has been updated. Note:
|
Coming soon/we are currently working on
| ID | Short description |
| Various | Performance improvements e.g. Finalisation section – implementation postponed |
| 207009 | Proof of Payment section: business rules fixes and non-CAP procedure support Expected deployment: Q1 2025 |
| 210325 | Present and Proposed section re-design and performance improvements implementation of the remaining features/functions. Expected deployment: Q1 2025 |
| eAF integrity stamp: Upon Finalising the application form, a digital signature confirming that the form has been exported from the PLM Portal is placed on the pdf export by the system Expected deployment: Q1 2025 | |
| Various | Analysis of the next set of structured changes e.g. ATC code, Medical Device |
Known Issues and Limitations
| ID | Short description |
| 185709 | Allow the selection of an ‘Alternative’ organisation name in the eAF (displayed on the pdf) |
| 217411 | Updates related to ‘Parallel Procedures’ section/other changes reflecting amended variation regulation (e.g. mandatory worksharing) – Harmonisation section is currently not displayed in the web UI |
| Known issue | When exporting the pdf, the export is intermittently not triggered on the first attempt but might require multiple attempts before succeeding. |
| Known issue | Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD. |
| Known issue | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known issue | In Medical Device section the ‘EU authorised representative’ option is missing |
| Known issue | The selections from the Medical Device section 4d. are not correctly reflected in the pdf export in some cases. Please note: for variation applications indicating a change in the device in section 4d. please consider using the interactive pdf eAF. |
| Known issue | Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish |
| Known issue | Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German |
| Known issue | In section Type(s) of Change(s) – scope selection: known issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided. |
| Known limitation | 23965 - Conditions and documentation are presented in different order from the variation classification guideline |
| Known limitation | Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss. |
| Known limitation | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted – will be resolved with the new present and proposed design |
| Known limitation | 22845 – Deletion of Application Form is not yet available |
| Known limitation | 23545 - Performance issues Number of sections take very long to open or to display the changes/selections made by the user; for example in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc. |
| Known limitation | Proof of Payment section: It is currently not possible to indicate different details for non-CAP WS variations for countries with pre-payment and countries with billing details |
| Known limitation | 23963 - Finalisation: Annexed document and Declaration Section are presented in random order |
| Product data quality/duplication of data | Product select screen shows 0/0 product presentation – this issue is derived from product duplication error caused by the system/incorrect data entry in xEVMPD leading to data error in PMS |
Version: 1.1.0.3 (Release date 25/11/2024)
Version Goal: New variation regulation updates and bug fixes
Date: 25/11/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.1.0.3 | This release note is for the version 1.1.0.3 release go-live 25/11/2024 |
Issues fixed in this version
| ID | Description | Comments |
| 207011 | New variation regulation e.g. super-grouping rules for non-CAPs | The business rules related to the super-groupings have been updated to reflect the amended variation regulation |
| 137105 | Contact person tooltip for CAPs | For CAPs, the instructions on the form on how to use the contact person field for procedures managed in IRIS were updated |
| 218049 | Bug – newly added package | A bug related to newly added Packaged Product not showing up in PDF was fixed |
| 211888 | Error message updated | The error message shown when there are product data issues with the selected products was updated. |
Coming soon/we are currently working on
| ID | Short description |
| 173444 | Application contact for non-CAPs should be multiselect. It is currently not possible to select the same contact person for more than 1 Member State, in case the same contact person if used for multiple member states the section needs to be repeated. |
| 217411 | Updates related to ‘Parallel Procedures’ section/other changes reflecting amended variation regulation (e.g. mandatory worksharing) |
| Various | Performance improvements e.g. Finalisation section |
| 207009 | Proof of Payment section: business rules fixes and non-CAP procedure support Expected deployment: Q1 2025 |
| Various | Present and Proposed section re-design Expected deployment: Q1 2025 |
| eAF integrity stamp: Upon Finalising the application form, a digital signature confirming that the form has been exported from the PLM Portal is placed on the pdf export by the system Expected deployment: Q1 2025 | |
| Various | Analysis of the next set of structured changes e.g. packages, manufacturers etc |
Known Issues and Limitations
| ID | Short description |
| 185709 | Allow the selection of an ‘Alternative’ organisation name in the eAF (displayed on the pdf) |
| Known issue | When exporting the pdf, the export is intermittently not triggered on the first attempt but might require multiple attempts before succeeding. |
| Known issue | Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD. |
| Known issue | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known issue | In Medical Device section the ‘EU authorised representative’ option is missing |
| Known issue | The selections from the Medical Device section 4d. are not correctly reflected in the pdf export in some cases. Please note: for variation applications indicating a change in the device in section 4d. please consider using the interactive pdf eAF. |
| Known issue | Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish |
| Known issue | Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German |
| Known issue | In section Type(s) of Change(s) – scope selection: known issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided. |
| Known limitation | 23965 - Conditions and documentation are presented in different order from the variation classification guideline |
| Known limitation | Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss. |
| Known limitation | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted – will be resolved with the new present and proposed design |
| Known limitation | 22845 – Deletion of Application Form is not yet available |
| Known limitation | 23545 - Performance issues Number of sections take very long to open or to display the changes/selections made by the user; for example in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc. |
| Known limitation | Proof of Payment section: It is currently not possible to indicate different details for non-CAP WS variations for countries with pre-payment and countries with billing details |
| Known limitation | 23963 - Finalisation: Annexed document and Declaration Section are presented in random order |
| Product data quality/duplication of data | Product select screen shows 0/0 product presentation – this issue is derived from product duplication error caused by the system/incorrect data entry in xEVMPD leading to data error in PMS |
Version: 1.1.0.2 (Release date 11/11/2024)
Version Goal: PLM Portal bug fix release
Date: 11/11/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.1.0.2 | This release note is for the version 1.1.0.2 release go-live 11/11/2024 |
Issues fixed in this version
| ID | Description | Comments |
| 195239 | Application list page (UI design) | The new User interface design has been implemented on the application list page |
Coming soon/we are currently working on
| ID | Short description |
| 173444 | Application contact for non-CAPs should be multiselect. It is currently not possible to select the same contact person for more than 1 Member State, in case the same contact person if used for multiple member states the section needs to be repeated. |
| Various | Performance improvements e.g. Finalisation section |
| Various | Present and Proposed section re-design Expected deployment: end of Q4 |
| 207011 | New variation regulation e.g. super-grouping rules for non-CAPs Expected deployment: before end of Q4 |
| 207009 | Proof of Payment section: business rules fixes and non-CAP procedure support Expected deployment: end of Q4 |
| eAF integrity stamp: Upon Finalising the application form, a digital signature confirming that the form has been exported from the PLM Portal is placed on the pdf export by the system | |
| 185709 | Allow the selection of an ‘Alternative’ organisation name in the eAF (displayed on the pdf) |
| Various | Analysis of the next set of structured changes e.g. packages, manufacturers etc |
Known Issues
| ID | Short description |
| Known limitation | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known issue | Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD. |
| Known limitation | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | In Medical Device section the ‘EU authorised representative’ option is missing. |
| Known limitation | 22845 – Deletion of Application Form is not yet available |
| Intermitted known issue | 25400 - Incorrect calculation of number of selected scopes in the summary page |
| Known limitation | 23965 - Conditions and documentation are presented in different order from the variation classification guideline |
| Known issue | In section Type(s) of Change(s) – scope selection: known issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided. |
| Known limitation | Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss. |
| Known limitation | 23545 - Performance issues Number of sections take very long to open or to display the changes/selections made by the user; for example in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc. |
| Known limitation | Proof of Payment section: It is currently not possible to indicate different details for non-CAP WS variations for countries with pre-payment and countries with billing details |
| Known limitation | 23963 - Finalisation: Annexed document and Declaration Section are presented in random order |
| Known issue | Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish |
| Known issue | Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German |
| Product data quality/duplication of data | Product select screen shows 0/0 product presentation – this issue is derived from product duplication error caused by the system/incorrect data entry in xEVMPD leading to data error in PMS |
Version: 1.1.0.1 (Release date 28/10/2024)
Version Goal: PLM Portal bug fix release
Date: 28/10/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.1.0.1 | This release note is for the version 1.1.0.1 release go-live 28/10/2024 |
Issues fixed in this version
| ID | Description | Comments |
| 192580 198781 | User Interface Design and UI Improvements | Home page User Interface improvements and other general rectifications |
| 197976 | Prevent parallel application cloning | Once the cloning of an application starts, another clone cannot be triggered. If the user tries to clone an application that is already in a cloning process, a pop-up message will appear on the screen |
| 206642 | Clone application improvements | When an application is cloned with the change of MAH, the products and attributes derived from products are erased. |
| 206987 | IRIS link added to PLM Portal | A link to IRIS Portal was added to the top right menu of the PLM Portal, for quicker access to IRIS. |
| 23546 | Orphan Drug improvements | In the Orphan Drug section in Additional Information, multiple designations can be added |
| 209832 | Nullified products filtered out | The Nullified products do not appear anymore in the selection of products |
| 182808 | Bug – Type(s) of changes identifier column | The Identified column in Type(s) of Changes is now shown in the correct position |
| 195016 | Bug – Signatory | A bug related to saving the signatory was fixed |
| 205779 | Bug (FHIR XML) – Incomplete scopes not added to the XML | A bug related to the presence of Incomplete scopes in the FHIR XML was fixed |
| 211947 | Bug – Type of change saving | A bug related to saving after adding a scope was fixed |
Coming soon/we are currently working on
| ID | Short description |
| 173444 | Application contact for non-CAPs should be multiselect. It is currently not possible to select the same contact person for more than 1 Member State, in case the same contact person if used for multiple member states the section needs to be repeated. |
| Various | Performance improvements e.g. Finalisation section |
| Various | Present and Proposed section re-design Expected deployment: end of Q4 |
| 207011 | New variation regulation e.g. super-grouping rules for non-CAPs Expected deployment: before end of Q4 |
| 207009 | Proof of Payment section: business rules fixes and non-CAP procedure support Expected deployment: end of Q4 |
| eAF integrity stamp: Upon Finalising the application form, a digital signature confirming that the form has been exported from the PLM Portal is placed on the pdf export by the system | |
| 185709 | Allow the selection of an ‘Alternative’ organisation name in the eAF (displayed on the pdf) |
| Various | Analysis of the next set of structured changes e.g. packages, manufacturers etc |
Known Issues
| ID | Short description |
| Known limitation | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known issue | Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD. |
| Known limitation | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | In Medical Device section the ‘EU authorised representative’ option is missing. |
| Known limitation | 22845 – Deletion of Application Form is not yet available |
| Intermitted known issue | 25400 - Incorrect calculation of number of selected scopes in the summary page |
| Known limitation | 23965 - Conditions and documentation are presented in different order from the variation classification guideline |
| Known issue | In section Type(s) of Change(s) – scope selection: known issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided. |
| Known limitation | Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss. |
| Known limitation | 23545 - Performance issues Number of sections take very long to open or to display the changes/selections made by the user; for example in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc. |
| Known limitation | Proof of Payment section: It is currently not possible to indicate different details for non-CAP WS variations for countries with pre-payment and countries with billing details |
| Known limitation | 23963 - Finalisation: Annexed document and Declaration Section are presented in random order |
| Known issue | Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish |
| Known issue | Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German |
| Product data quality/duplication of data | Product select screen shows 0/0 product presentation – this issue is derived from product duplication error caused by the system/incorrect data entry in xEVMPD leading to data error in PMS |
Version: 1.1 (Release date 14/10/2024)
Version Goal: PLM Portal bug fix release
Date: 14/10/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.1 | This release note is for the version 1.1 release go-live 14/10/2024 |
Issues fixed in this version
| ID | Description | Comments |
| Non-Centrally Authorised Products (non-CAPs) go-live in the web-based eAF | Products authorised through Mutual Recognition Procedure (MRP), Decentralised Procedure (DCP) and National Procedures (NP) are now available in the eAF for familiarisation and training purposes. Please note that it is not yet possible to submit eAFs generated form the PLM Portal to NCAs. The web-based application form can be used for EMA-led worksharing applications containing CAPs and non-CAPs. | |
| 175342 | RMS/CMS selection of single MRP product | It is now possible to correctly indicate the Reference Member State for products authorised through MRP procedure. |
| 207814 | Part 2: Filter out CAPs that do not have authorisation country EU (Norway, Iceland, Liechtenstein) on the parallel procedures and orphan product selection tables. | Ther CAPs are showing only once also in the product selection windows in parallel procedures section and in the Orphan products section. The entries for Norway, Iceland and Lichtenstein are not visible anymore. |
| 198291 | Performance – Optimise indexing in tables | The performance has been improved in areas where tables are shown. |
| 23849 | Annexed documents section: External links in the help text cannot be selected easily | The external links in the help text can now be selected easily. |
| 202259 | Checkbox on ‘View selected products’ not functional | The checkbox in the selected products view can now be ticked/unticked as needed. |
| 204369 | Regression error – error 500 shown in production | Production bug preventing the use of the forms (error Status 500) was fixed in production on the day it occurred. |
| 205988 | Product selection not working properly | Partially fixed: please note that while majority of the filters now work as expected, there is still a bug in the authorised dose form filter. You might need to refresh to restart search. We are working to fix this. |
Coming soon/we are currently working on
| ID | Short description |
| 209832 | Filter out nullified products: this user story will remove number of products that appear as duplicates for the end user in product selection. The nullified products in currently causing an incorrect error message to be displayed (error message refers to product/scope combination) and in some cases these nullified products preventing the use of the web-based form. Expected fix deployment date: 28th October 2024 |
| 173444 | Application contact for non-CAPs should be multiselect. It is currently not possible to select the same contact person for more than 1 Member State, in case the same contact person if used for multiple member states the section needs to be repeated. |
| Various | Performance improvements e.g. Finalisation section |
| Various | Present and Proposed section re-design Expected deployment: end of Q4 |
| 207011 | New variation regulation e.g. super-grouping rules for non-CAPs Expected deployment: before end of Q4 |
| 207009 | Proof of Payment section: business rules fixes and non-CAP procedure support Expected deployment: end of Q4 |
| eAF integrity stamp: Upon Finalising the application form, a digital signature confirming that the form has been exported from the PLM Portal is placed on the pdf export by the system | |
| 185709 | Allow the selection of an ‘Alternative’ organisation name in the eAF (displayed on the pdf) |
| Various | Analysis of the next set of structured changes e.g. packages, manufacturers etc |
Known Issues
| ID | Short description |
| Known limitation | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known issue | Cyrillic characters showing ‘?’ in the full name field – this is not a data issue but reflecting data from xEVMPD. This needs to be corrected by the respective MAHs with new version of product to be sent to xEVMPD. |
| Known limitation | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | In Medical Device section the ‘EU authorised representative’ option is missing. |
| Known limitation | 22845 – Deletion of Application Form is not yet available |
| Intermitted known issue | 25400 - Incorrect calculation of number of selected scopes in the summary page |
| Known limitation | 23965 - Conditions and documentation are presented in different order from the variation classification guideline |
| Known issue | In section Type(s) of Change(s) – scope selection: known issue where selection of all conditions and documentations using the high level tickbox will result an error message saying all conditions and documentations should be selected or note should be provided. |
| Known limitation | Concurrent users – there is currently a limitation in the system where 2 or more users can work at the same time in the same application form, however, the changes cannot be saved at the same time and this could lead into data loss by one of the concurrent users. It is strongly recommended to organise a workflow internally to avoid any data loss. |
| Known limitation | 23545 - Performance issues Number of sections take very long to open or to display the changes/selections made by the user; for example in Finalisation section, most functions take much longer than acceptable e.g. displaying the parallel procedures section can take up to 1 minute etc. |
| Known limitation | Proof of Payment section: It is currently not possible to indicate different details for non-CAP WS variations for countries with pre-payment and countries with billing details |
| Known limitation | 23963 - Finalisation: Annexed document and Declaration Section are presented in random order |
| Known issue | Products authorised in Finland: The full name of product is displayed (randomly) either in Finnish or Swedish |
| Known issue | Products authorised in Belgium: The full name of product is displayed (randomly) either in Flemish, French or German |
| Product data quality/duplication of data | Product select screen shows 0/0 product presentation – this issue is derived from product duplication error caused by the system/incorrect data entry in xEVMPD leading to data error in PMS |
Version: 1.0.1.19 (Release date 18/09/2024)
Version Goal: PLM Portal bug fix release
Date: 18/09/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
Functionality/use case | Component | Short description |
Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.19 | This release note is for the version 1.0.1.19 release go-live 18/09/2024 |
Issues fixed in this version
ID | Description | Comments |
193714 | Performance improvements – Product selection | New search functionality in the product selection window (the table doesn’t show any product initially, the user must search the products; each column can be filtered) |
163771 | Norway, Iceland, Lichtenstein entries filtered | Ther CAPs are showing only once in the product selection window, the entries for Norway, Iceland and Lichtenstein are not visible anymore |
Coming soon/we are currently working on
| ID | Component | Short description |
| Various | Human Variations eAF | Performance improvements |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
Known Issues
| ID | Component | Short description |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | PLM Portal | 22845 – Deletion of Application Form is not yet available |
| Intermitted known issue | Human Variations eAF | 25400 - Incorrect calculation of number of selected scopes in the summary page |
| 23545 | PLM Portal | Performance issues |
| Known limitation | Human Variations eAF | 23963 - Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| Known limitation | Human Variations eAF | 23965 - Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| Known limitation | Human Variations eAF | 23971 - Proposal for Organisation Details – Split Text |
| Product data quality/duplication of data | Human Variations eAF | Product select screen shows 0/0 product presentation – this issue is derived from product duplication error caused by the system/incorrect data entry in xEVMPD leading to data error in PMS |
Version: 1.0.1.18 (Release date 06/09/2024)
Version Goal: PLM Portal bug fix release
Date: 06/09/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
Functionality/use case | Component | Short description |
Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.18 | This release note is for the version 1.0.1.18 release go-live 06/09/2024 |
Issues fixed in this version
ID | Description | Comments |
200733 | Application form ID added to the PDF | The application form ID (for example: VAR/24/1234) is now on the exported PDF, at the bottom of the page |
204228 | Label “Changes implementation comment” added to the PDF | In the “Declaration of the application” section in PDF, the comment related to the implementation is now labelled with “Changes implementation comment” |
200739 | Additional signatory and proof of payment – location in PDF | The main and additional signatory and proof of payment sections are now separate in the PDF |
192307 | Clone application - Block application during cloning | Some functions of the eAF are temporarily blocked when the cloning of an application has started. Maintenance popup messages are visible on the screen while the cloning is being finalised; a maintenance popup message will appear when opening an application that was not cloned properly, guiding the users on the possible actions to be taken |
201530 | Bug – Proposed changes | The proposed changes text appears now for all applications in the Present/Proposed list |
135095 | Bug – Medical device | The update of manufacturing and notified body is now reflected correctly in the medical device section |
Coming soon/we are currently working on
| ID | Component | Short description |
| Various | Human Variations eAF | Performance improvements |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
Known Issues
| ID | Component | Short description |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | PLM Portal | 22845 – Deletion of Application Form is not yet available |
| Intermitted known issue | Human Variations eAF | 25400 - Incorrect calculation of number of selected scopes in the summary page |
| 23545 | PLM Portal | Performance issues |
| Known limitation | Human Variations eAF | 23963 - Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| Known limitation | Human Variations eAF | 23965 - Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| Known limitation | Human Variations eAF | 23971 - Proposal for Organisation Details – Split Text |
| Product data quality/duplication of data | Human Variations eAF | Product select screen shows 0/0 product presentation – this issue is derived from product duplication error caused by the system/incorrect data entry in xEVMPD leading to data error in PMS |
Version: 1.0.1.17 (Release date 27/08/2024)
Version Goal: PLM Portal bug fix release
Date: 27/08/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.17 | This release note is for the version 1.0.1.17 release go-live 27/08/2024 |
Issues fixed in this version
| ID | Description | Comments |
| 183078 | Performance improvements – Product selection | Performance improvements were implemented for the Product selection section: after adding a new product several functions (i.e. Add product, Export, Finalise) are blocked until all the processes in the background are finalised, and the user will see a popup message “We are currently executing critical maintenance tasks, including data synchronisation and computational adjustments, on your application. To ensure the highest level of data integrity, access to certain functionalities will be temporarily restricted. We appreciate your patience and understanding while these enhancements are underway.” The functions will be accessible once the processes are finished. |
| 193717 164815 193709 193727 | Performance improvements | Performance improvements were implemented for the following sections of the application:
|
| 134341 | Bug - Validation error "The field EMA procedure number/Competent Authority is required." | In the additional details, for "Type IB and Type II variations - Paediatric Requirements", the validation error "The field EMA procedure number/Competent Authority is required." does no longer appear upon saving the page. |
| 189849 | Bug - Ordering of Products on Product Selection | The display of the products on Product selection section is again based on alphabetical order. |
| 189854 | Bug – packages | Packages are now loading faster under Product selection and Present/Proposed section |
| 197043 | Bug – View selected products | In the “View selected products”, now all selected products are shown |
| 199677 | Bug – Signatory date | In the main and additional signatory, the date remains as selected by the user |
Coming soon/we are currently working on
| ID | Component | Short description |
| Various | Human Variations eAF | Performance improvements |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
Known Issues
| ID | Component | Short description |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | PLM Portal | 22845 – Deletion of Application Form is not yet available |
| Intermitted known issue | Human Variations eAF | 25400 - Incorrect calculation of number of selected scopes in the summary page |
| 23545 | PLM Portal | Performance issues |
| Known limitation | Human Variations eAF | 23963 - Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| Known limitation | Human Variations eAF | 23965 - Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| Known limitation | Human Variations eAF | 23971 - Proposal for Organisation Details – Split Text |
| Product data quality/duplication of data | Human Variations eAF | Product select screen shows 0/0 product presentation – this issue is derived from product duplication error caused by the system/incorrect data entry in xEVMPD leading to data error in PMS |
Version: 1.0.1.16 (Release date 08/08/2024)
Version Goal: PLM Portal bug fix release
Date: 08/08/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.16 | This release note is for the version 1.0.1.16 release go-live 08/08/2024 |
Issues fixed in this version
ID | Description | Comments |
187787 | Orphan products – replace column in Additional information | Display the date of the first authorisation in the Orphan Products subsection and Additional Information section replacing the existing field Authorisation status state for all the level of products (Authorisation, Medicinal and Packaged) |
26203 | Number of selected packages fix | The number of selected packages is now shown correctly in the product selection tab after changing the selection in the Present/Proposed section |
197933 | PDF Fix | "Information on harmonisation of product information for MRP/DCP/purely nationally authorised products" now is showing correctly in the Signature section
|
Coming soon/we are currently working on
| ID | Component | Short description |
| Various | Human Variations eAF | Performance improvements |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
Known Issues
| ID | Component | Short description |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | PLM Portal | 22845 – Deletion of Application Form is not yet available |
| Intermitted known issue | Human Variations eAF | 25400 - Incorrect calculation of number of selected scopes in the summary page |
| 23545 | PLM Portal | Performance issues |
| Known limitation | Human Variations eAF | 23963 - Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| Known limitation | Human Variations eAF | 23965 - Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| Known limitation | Human Variations eAF | 23971 - Proposal for Organisation Details – Split Text |
| Product data quality/duplication of data | Human Variations eAF | Product select screen shows 0/0 product presentation – this issue is derived from product duplication error caused by the system/incorrect data entry in xEVMPD leading to data error in PMS |
Version: 1.0.1.15 (Release date 22/07/2024)
Version Goal: PLM Portal bug fix release
Date: 22/07/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.15 | This release note is for the version 1.0.1.15 release go-live 22/07/2024 |
Issues fixed in this version
| ID | Description | Comments |
| 187483 | Add package improvements | The lookup in the parent medicinal product opens a new window where the medicinal products selected in the application can be filtered. When a new package is added for a specific product, that product is auto-selected for the scope that is being edited. |
| 195791 | Second signatory fix | A bug causing an empty second signatory to be shown in the exported PDF was fixed. |
| 22513 | Pending products | The filters applied to the products were changed to include pending products. |
| 194331 | Copy application fix | A bug related to the “next” button on the second page in the process of copying an application was fixed. |
| 194960 | Finalisation fix | A bug related to the finalisation of a form was fixed. |
| 194350 | Note in type of changes fix | A bug related to the notes from types of changes disappearing was fixed. |
| 195926 | Proof of payment PDF fix* | Telephone number and email related to proof of payment are now correctly mapped in the PDF |
| 197870 | Active substance PDF fix* | Active substance, if identical for several medicinal products, is no longer multiplied in the PDF |
*related to the PDF, added in the release notes on the 30th of July
Coming soon/we are currently working on
| ID | Component | Short description |
| Various | Human Variations eAF | Performance improvements |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
Known Issues
| ID | Component | Short description |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | PLM Portal | 22845 – Deletion of Application Form is not yet available |
| Intermitted known issue | Human Variations eAF | 25400 - Incorrect calculation of number of selected scopes in the summary page |
| 23545 | PLM Portal | Performance issues |
| Known limitation | Human Variations eAF | 23963 - Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| Known limitation | Human Variations eAF | 23965 - Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| Known limitation | Human Variations eAF | 23971 - Proposal for Organisation Details – Split Text |
| Product data quality/duplication of data | Human Variations eAF | Product select screen shows 0/0 product presentation – this issue is derived from product duplication error caused by the system/incorrect data entry in xEVMPD leading to data error in PMS |
Version: 1.0.1.14 (Release date 15/07/2024)
Version Goal: PLM Portal bug fix release
Date: 15/07/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.14 | This release note is for the version 1.0.1.14 release go-live 15/07/2024 |
Issues fixed in this version
| ID | Description | Comments |
| 25715 | Human Variations eAF | ‘Add package’ to enable the use for variations that add new presentation |
| 184243 | Updated validation error message for ’Change(s) Concern(s)’ | The validation error message has been updated to clarify the business rule in ’Change(s) Concern(s)’ field. |
| 181541 | Organisations using ‘OMS’ status | Organisations used in eAF are now retrieved based on OMS status. This change will also prevent accidental selection of inactive organisations as the correct OMS status is displayed with it’s status). |
Coming soon/we are currently working on
| ID | Component | Short description |
| Various | Human Variations eAF | Performance improvements |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
Known Issues
| ID | Component | Short description |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | PLM Portal | 22845 – Deletion of Application Form is not yet available |
| Intermitted known issue | Human Variations eAF | 25400 - Incorrect calculation of number of selected scopes in the summary page |
| 23545 | PLM Portal | Performance issues |
| Known limitation | Human Variations eAF | 23963 - Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| Known limitation | Human Variations eAF | 23965 - Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| Known limitation | Human Variations eAF | 23971 - Proposal for Organisation Details – Split Text |
| Product data quality/duplication of data | Human Variations eAF | Product select screen shows 0/0 product presentation – this issue is derived from product duplication error caused by the system/incorrect data entry in xEVMPD leading to data error in PMS |
Version: 1.0.1.13 (Release date 13/05/2024)
Version Goal: PLM Portal bug fix release
Date: 13/05/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.13 | This release note is for the version 1.0.1.13 release go-live 13/05/2024 |
Issues fixed in this version
| ID | Description | Comments |
| 29109 | Human Variations eAF | Improve communication – ‘news’ tile on homepage |
| 164785 | Performance improvements for Applications List page | The applications list page has been performance optimised. 50 most recent forms created/edited will be shown on the page, to see other, previously created/edited forms new ‘Load more’ button has been added. Note: The search only searches within the first 50 entries if the ‘load more’ has not been clicked. |
| 164785 | Human Variations eAF | Form type (variation) auto selected to improve user experience (no need to select a single value from a list. |
| 15504 | Human Variations eAF | Deleted product package details are still appearing in Proposed changes section |
| 174539 | eAF product deletion from Application | When product has been deleted from the system, it will also be deleted from the FHIR |
Coming soon/we are currently working on
| ID | Component | Short description |
| 25715 | Human Variations eAF | ‘Add package’ to enable the use for variations that add new presentation |
| 29121 | Human Variations eAF | Improve communication – guidance and support page |
| 35130 | Human Variations eAF | Improve communication – change guidance documentation on login page from IRIS to PLM Portal |
Known Issues
| ID | Component | Short description |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 26203 | Human Variations eAF | Number of selected packages are not updated correctly |
| 23910 | Human Variations eAF | Inconsistent button behaviour by viewing 'selected packaged medicinal product(s)' |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
Version: 1.0.1.13 (Release date 15/02/2024)
Version Goal: PLM Portal bug fix release
Date: 05/02/2024
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.13 | This release note is for the version 1.0.1.13 release go-live 05/02/2024 |
Issues fixed in this version
| ID | Description | Comments |
| 11086 | Clone application (copy application) | Applicants can now clone (copy) an existing application form to reduce administrative work. It is possible to fully clone the application or copy certain application details and change the MAH. We are aware of some cases where the clone is not copying all fields/sections for example for medical devices or GMO. Also, please note that it can take up to 2 minutes to create the clone. If the copy function has not worked, you will get an error message and depending on the issue, you can try again or raise a service desk ticket with details of the incident. If you experience issues, kindly write a support ticket with the variation ID. |
| 6770 (246) | Human Variations eAF | Rename application |
| 132950 | Packages are not showing up | Intermitted issue where packages are not displayed in the present and proposed section has been solved in relation to upcoming feature ‘add package’. |
Known Issues
| ID | Component | Short description |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 15504 | Human Variations eAF | Deleted product package details are still appearing in Proposed changes section |
| 26203 | Human Variations eAF | Number of selected packages are not updated correctly |
| 23910 | Human Variations eAF | Inconsistent button behaviour by viewing 'selected packaged medicinal product(s)' |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
Version: 1.0.1.12 (Release date 27/11/2023)
Version Goal: PLM Portal bug fix release
Date: 27/11/2023
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.12 | This release note is for the version 1.0.1.12 release go-live 27/11/2023 |
Issues fixed in this version
| ID | Description | Comments |
| 37644 | Clone variation scope | Applicants can now clone an existing scope to reduce administrative work, if an application should contain the same scope multiple times. We are aware of a very rare case where the clone is not showing up right away and requires a page refresh. If you experience this issue, kindly write a support ticket with the variation ID and the version of the browser you are using. |
| n/a | Version number correction | The version number of the eAF was updated to 1.0.1.12 |
Coming soon/we are currently working on
| ID | Component | Short description |
| 11086 | PLM Portal | Copy application feature not available yet |
| 246 | Human Variations eAF | It is not possible to change the ‘Friendly name’ |
| 25715 | Human Variations eAF | Form cannot be used for variations that add new presentation |
| 29109 | Human Variations eAF | Improve communication – ‘news’ tile on homepage |
| 29121 | Human Variations eAF | Improve communication – guidance and support page |
| 35130 | Human Variations eAF | Improve communication – change guidance documentation on login page from IRIS to PLM Portal |
Known issues
| ID | Component | Short description |
| 133199 | Human Variations eAF | Cloned scopes do not appear immediately, only after a page refresh |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| 38300 | FHIR xml | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 15504 | Human Variations eAF | Deleted product package details are still appearing in Proposed changes section |
| 26157 | Human Variations eAF | Packages missing in UAT which are in Production |
| 26203 | Human Variations eAF | Number of selected packages are not updated correctly |
| 23910 | Human Variations eAF | Inconsistent button behaviour by viewing 'selected packaged medicinal product(s)' |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
| 25301 | Human Variations eAF | Precise scope and background for information section not saved |
| 24731 | Human Variations eAF | The Proposed Package Item Content is not linked to Application Form |
Version: 1.0.1.11 (Release date 07/08/2023)
Version Goal: PLM Portal bug fix release
Date: 07/08/2023
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.11 | This release note is for the BUGFIX version 1.0.1.11 release go-live 07/08/2023 |
Issues fixed in this version
| ID | Description | Comments |
| 101118 | View coordinators on co-authors | Users can see in the “Co-authors” page of an application the coordinators with implicit access to that form |
Coming soon/we are currently working on
| ID | Component | Short description |
| 11086 | PLM Portal | Copy application feature not available yet |
| 246 | Human Variations eAF | It is not possible to change the ‘Friendly name’ |
| 25715 | Human Variations eAF | Form cannot be used for variations that add new presentation |
| 37644 | Human Variations eAF | Cannot clone variation scopes added in the form (convenience feature when adding multiple times the same scope) |
| 29109 | Human Variations eAF | Improve communication – ‘news’ tile on homepage |
| 29121 | Human Variations eAF | Improve communication – guidance and support page |
| 35130 | Human Variations eAF | Improve communication – change guidance documentation on login page from IRIS to PLM Portal |
Known issues
| ID | Component | Short description |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| 38300 | FHIR xml | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 15504 | Human Variations eAF | Deleted product package details are still appearing in Proposed changes section |
| 26157 | Human Variations eAF | Packages missing in UAT which are in Production |
| 26203 | Human Variations eAF | Number of selected packages are not updated correctly |
| 23910 | Human Variations eAF | Inconsistent button behaviour by viewing 'selected packaged medicinal product(s)' |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
| 25301 | Human Variations eAF | Precise scope and background for information section not saved |
| 24731 | Human Variations eAF | The Proposed Package Item Content is not linked to Application Form |
Version: 1.0.1.9 (Release date 13/06/2023)
Version Goal: PLM Portal bug fix release
Date: 13/06/2023
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.9 | This release note is for the BUGFIX version 1.0.1.9 release go-live 13/06/2023 |
Issues fixed in this version
| ID | Description | Comments |
| 16208 | Select All button must select all the available records in Available Products table and Packaged Products table | Also products that are not displayed on the page (in case of pagination) are selected when select all button is used. NOTE: only packages that have been loaded already will be selected. It is very important to check that all packages needed have been loaded and selected prior to finalising the form. |
| 23547 | Procedural information: Some mandatory fields are not mandatory in the form | The following fields are now mandatory:
|
| 23896 | Error after wrong date format for Implementation date | When the implementation date format is entered incorrectly (in Type(s) of Change(s) Type IA/Type IAIN only, the correct validation message is now displayed. |
| 25396 | Packaged medicinal products are not shown when combining scopes and medicinal products | An issue related to display of packaged medicinal products in some applications has now been fixed and all packaged medicinal products for the selected medicinal products should now be visible in the Proposed changes section. NOTE: This is a partial fix to the issue as only those product/packages that have been loaded by the system are visible. There is a delay in loading the packages in Present and Proposed table. The delay issue will be addressed in a future release. |
| 76861 | Select All in combination with pagination will delete the previous selection | An issue related to applications containing more than 50 packaged medicinal products has been fixed. It is now possible to select all packages for all selected medicinal products NOTE: There is a known issue affecting this section and only approx. 200 packages can be selected at one time. |
| 77891 | Update the Validation Status of Procedural Information Section | Any field validation change should update the validation status. NOTE: This is a partial fix to the issue. The section level validation will remain valid (green) and will only reflect the ‘not completed’ status only if the ‘validate button is repressed. Field level validation errors are shown correctly. |
| 86890 | Packages may not be loaded in when present/proposed is opened | The packages table on the proposed changes screen will now have a loading circle (spinner) to indicate that it is waiting on backend processes to finish creating the relevant records. Once the backend processes finish, the spinner will disappear, and the table will be loaded. There is no need to refresh the page as the table will load on its own. |
| 93686 | Friendly name validates at 100 chars but fails at 80 chars already | A technical issue (bug) detected on the background preventing finalisation of the eAF with a Friendly name exceeding 80 characters has been fixed. |
| 94280 | MAH phone number should validate without save | The validation error is no longer displayed when the ‘validate’ button is pressed after including the MAH phone number. |
| 95272 | Procedural Information - Reference Member State field error | Only relevant to WS procedures that do not contain any CAPs (fixed in preparation for NAPs release):
|
Coming soon/we are currently working on
| ID | Component | Short description |
| 11086 | PLM Portal | Copy application feature not available yet |
| 246 | Human Variations eAF | It is not possible to change the ‘Friendly name’ |
| 25715 | Human Variations eAF | Form cannot be used for variations that add new presentation |
| 37644 | Human Variations eAF | Cannot clone variation scopes added in the form (convenience feature when adding multiple times the same scope) |
| 29109 | Human Variations eAF | Improve communication – ‘news’ tile on homepage |
| 29121 | Human Variations eAF | Improve communication – guidance and support page |
| 35130 | Human Variations eAF | Improve communication – change guidance documentation on login page from IRIS to PLM Portal |
Known issues
| ID | Component | Short description |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| 38300 | FHIR xml | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 15504 | Human Variations eAF | Deleted product package details are still appearing in Proposed changes section |
| 26157 | Human Variations eAF | Packages missing in UAT which are in Production |
| 26203 | Human Variations eAF | Number of selected packages are not updated correctly |
| 23910 | Human Variations eAF | Inconsistent button behaviour by viewing 'selected packaged medicinal product(s)' |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
| 25301 | Human Variations eAF | Precise scope and background for information section not saved |
| 24731 | Human Variations eAF | The Proposed Package Item Content is not linked to Application Form |
Version: 1.0.1.8 (Release date 16/05/2023)
Version Goal: PLM Portal bug fix release
Date: 16/05/2023
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.8 | This release note is for the BUGFIX version 1.0.1.8 release go-live 16/05/2023 |
| Update of the human readable pdf export | PDF version 2.0.5.1 | This release note is for the BUGFIX version 2.0.5.1 release go-live 20/02/2023 |
| Implementation of the FHIR xml | FHIR XML 1.1.2.0 |
Issues fixed in this version
| ID | Description | Comments |
| 25396 | Packaged medicinal products are not shown when combining scopes and medicinal products | An issue related to display of packaged medicinal products in some applications has now been fixed and all packaged medicinal products for the selected medicinal products should now be visible in the Proposed changes section. NOTE: This is a partial fix to the issue as only those product/packages that have been loaded by the system are visible. There is a delay in loading the packages in Present and Proposed table. The delay issue will be addressed in a future release. |
| 76861 | Select All in combination with pagination will delete the previous selection | An issue related to applications containing more than 50 packaged medicinal products has been fixed. It is now possible to select all packages for all selected medicinal products |
| 93686 | Friendly name validates at 100 chars but fails at 80 chars already | A technical issue (bug) detected on the background preventing finalisation of the eAF with a Friendly name exceeding 8 characters has been fixed. |
Known issues
| ID | Component | Short description |
| 16208 | Human Variations eAF | Select All button must select all the available records in Available Products table and Packaged Products table |
| 11086 | PLM Portal | Copy application feature not available yet |
| 246 | Human Variations eAF | It is not possible to change the ‘Friendly name’ |
| 25715 | Human Variations eAF | Form cannot be used for variations that add new presentation |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| 37644 | Human Variations eAF | Cannot clone variation scopes added in the form (convenience feature when adding multiple times the same scope) |
| 38300 | FHIR xml | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| 23547 | Human Variations eAF | Procedural information: Some mandatory fields are not mandatory in the form |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 15504 | Human Variations eAF | Deleted product package details are still appearing in Proposed changes section |
| 29109 | Human Variations eAF | Improve communication – ‘news’ tile on homepage |
| 29121 | Human Variations eAF | Improve communication – guidance and support page |
| 35130 | Human Variations eAF | Improve communication – change guidance documentation on login page from IRIS to PLM Portal |
| 26157 | Human Variations eAF | Packages missing in UAT which are in Production |
| 26203 | Human Variations eAF | Number of selected packages are not updated correctly |
| 23910 | Human Variations eAF | Inconsistent button behaviour by viewing 'selected packaged medicinal product(s)' |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23896 | Human Variations eAF | Error after wrong date format for Implementation date |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
| 25301 | Human Variations eAF | Precise scope and background for information section not saved |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 24731 | Human Variations eAF | The Proposed Package Item Content is not linked to Application Form |
Version: 1.0.1.7 (Release date 17/04/2023)
Version Goal: PLM Portal bug fix release
Date: 17/04/2023
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.7 | This release note is for the BUGFIX version 1.0.1.7 release go-live 17/04/2023 |
| Update of the human readable pdf export | PDF version 2.0.5.1 | This release note is for the BUGFIX version 2.0.5.1 release go-live 20/02/2023 |
| Implementation of the FHIR xml | FHIR XML 1.1.2.0 |
Issues fixed in this version
| ID | Description | Comments |
| 37806 | Enable search of EU Orphan designations using the EU Orphan Designation number(s) | It is now easier to add the EU Orphan designation numbers into the section 4a on Information relating to orphan market exclusivity |
| 42683 | The ATC code should also display the ATC code group in the PDF | The pdf output now also displays the ATC code group in addition to the ATC code. |
| 59912 | Regression: too many options visible in the dropdown for applicant contributor | The number of features/functions available for Contributor is now limited in the list of applications dropdown menu (no functional change) |
Known issues
| ID | Component | Short description |
| 11086 | PLM Portal | Copy application feature not available yet |
| 246 | Human Variations eAF | It is not possible to change the ‘Friendly name’ |
| 25715 | Human Variations eAF | Form cannot be used for variations that add new presentation |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| 37644 | Human Variations eAF | Cannot clone variation scopes added in the form (convenience feature when adding multiple times the same scope) |
| 38300 | FHIR xml | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| 23547 | Human Variations eAF | Procedural information: Some mandatory fields are not mandatory in the form |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 15504 | Human Variations eAF | Deleted product package details are still appearing in Proposed changes section |
| 29109 | Human Variations eAF | Improve communication – ‘news’ tile on homepage |
| 29121 | Human Variations eAF | Improve communication – guidance and support page |
| 35130 | Human Variations eAF | Improve communication – change guidance documentation on login page from IRIS to PLM Portal |
| 26157 | Human Variations eAF | Packages missing in UAT which are in Production |
| 26203 | Human Variations eAF | Number of selected packages are not updated correctly |
| 23910 | Human Variations eAF | Inconsistent button behaviour by viewing 'selected packaged medicinal product(s)' |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23896 | Human Variations eAF | Error after wrong date format for Implementation date |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
| 25301 | Human Variations eAF | Precise scope and background for information section not saved |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 24731 | Human Variations eAF | The Proposed Package Item Content is not linked to Application Form |
Version: 1.0.1.6 (Release date 21/02/2023)
Version Goal: PLM Portal bug fix release
Date: 21/02/2023
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.6 | This release note is for the BUGFIX version 1.0.1.6 release go-live 21/02/2023 |
| Update of the human readable pdf export | PDF version 2.0.5.1 | This release note is for the BUGFIX version 2.0.5.1 release go-live 20/02/2023 |
| Update of the human readable pdf export | PDF Version 2.0.2.2* *Please note that the newly introduced 4th number refers to technical changes in the pdfgen. These do not refer to change in the pdf output form used by business users. | This release note is for the BUGFIX version 2.0.2 release go-live 06/02/2023 |
| Implementation of the FHIR xml | FHIR XML 1.1.2.0 | Release go-live 10/02/2023:
|
Issues fixed in this version
| ID | Description | Comments | |
| 22398 | Present and Proposed section:
| Input fields for the ASMF number and DUNS number have been added to the web UI of eAF. When added in the form, the ASMF numbers will be presented as a part of the present and proposed table, not as a separate field below all present and proposed fields like in the interactive pdf. The DUNS number field will only be displayed in the pdf if value is added to that field in the web eAF. The DUNS number is displayed as a part of the organisational information and not as a separate field below all present and proposed fields like in the interactive pdf. | |
| 38757 | Application Forms view – Label change to the drop down options | In the application forms list view, the menu options on the right hand side dropdown selection now indicate ‘Coming soon’ for those features that are not yet available (for example Copy Application). | |
| 40214 | Image resize issue | The images are now displayed in a legible format in the present and proposed fields. The fields in present and proposed can be now used as per normal. | |
| 27729 | Clicking 'validate' immediately after clicking 'save' throws an error (RPI cannot be blank for CAP products). | The error message is no longer displayed when the RPI is present and even if the ‘validate’ button is clicked before the packages are loaded. | |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products | |
| 42871 | 3 new tick boxes related to personal data are missing from the Declaration section when SPC, PI or labelling is ticked in Annexed documents section. | The mandatory tick boxes are now available in Declaration section when expected and no validation error is displayed. | |
| 37507 | Correct typos – present and proposed section: Pharmacovigilance’ | Typo has been corrected in the dropdown list of proposed changes |
Known issues
| ID | Component | Short description |
| Known limitation | PLM Portal | Copy application feature not available yet |
| Known limitation | Human Variations eAF | It is not possible to change the ‘Friendly name’ |
| Known limitation | Human Variations eAF | Form cannot be used for variations that add new presentation |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| 37644 | Human Variations eAF | Cannot clone variation scopes added in the form (convenience feature when adding multiple times the same scope) |
| 38300 | FHIR xml | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| 37806 | Human Variations eAF | Enable search of EU Orphan designations using the EU Orphan Designation number(s) |
| 23547 | Human Variations eAF | Procedural information: Some mandatory fields are not mandatory in the form |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 23910 | Human Variations eAF | eAF allows only two signatories |
| 15504 | Human Variations eAF | Deleted product package details are still appearing in Proposed changes section |
| 29109 | Human Variations eAF | Improve communication – ‘news’ tile on homepage |
| 29121 | Human Variations eAF | Improve communication – guidance and support page |
| 35130 | Human Variations eAF | Improve communication – change guidance documentation on login page from IRIS to PLM Portal |
| 26157 | Human Variations eAF | Packages missing in UAT which are in Production |
| 26203 | Human Variations eAF | Number of selected packages are not updated correctly |
| 23910 | Human Variations eAF | Inconsistent button behaviour by viewing 'selected packaged medicinal product(s)' |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23896 | Human Variations eAF | Error after wrong date format for Implementation date |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23969 | Human Variations eAF | Cannot select more than one organisation in Proposed Organisation field |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24905 | Country name shown is long version in PDF | |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
| 25301 | Human Variations eAF | Precise scope and background for information section not saved |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 24731 | Human Variations eAF | The Proposed Package Item Content is not linked to Application Form |
Version: 1.0.1.4 (Release date 23/01/2023)
Version Goal: PLM Portal bug fix release
Date: 23/01/2023
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.4 | This release note is for the BUGFIX version 1.0.1.4 release go-live 23/01/2023 |
| Update of the human readable pdf export | PDF Version 2.0.2.2* *Please note that the newly introduced 4th number refers to technical changes in the pdfgen. These do not refer to change in the pdf output form used by business users. | This release note is for the BUGFIX version 2.0.2 release go-live 23/01/2023 |
Issues fixed in this version
| ID | Description | Comments |
| 24184 – web eAF | Add a link to the Guidance for applicants on precise scope | The Guidance for applicants for the preparation of the ‘precise scope’ section of the variation application form is now available via a link in the Precise Scope section (via ‘info’ button) |
| 35219 – web eAF | Proposed Changes Section: Upload Image Error in Rich Text Box Field | It is now possible to include images in the Present and Proposed fields (the production issue has been fixed). |
| 24565 – web eAF | Limit width of free text fields | The images are now displayed in more legible format in the present and proposed fields. |
| 25713 – web eAF | Info text for commercially confidential data is incorrect | The information text explaining the details related to access management in relation to CCI have been clarified and corrected. |
Known issues
| ID | Component | Short description |
| Known limitation | PLM Portal | Copy application feature not available yet |
| Known limitation | Human Variations eAF | It is not possible to change the ‘Friendly name’ |
| Known limitation | Human Variations eAF | Form cannot be used for variations that add new presentation |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| Known limitation | Human Variations eAF | Cannot clone variation scopes added in the form (convenience feature when adding multiple times the same scope) |
| Known limitation | FHIR xml | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| 27729 | Human Variations eAF | Clicking 'validate' immediately after clicking 'save' throws an error (RPI cannot be blank for CAP products). This error message is incorrect and doesn’t at all have anything to do with RPI. |
| 23547 | Human Variations eAF | Procedural information: Some mandatory fields are not mandatory in the form |
| 22398 | Human Variations eAF | Present and Proposed section: ASMF number and DUNS number fields missing from the Web UI. Workaround: If these need to be provided, please use Precise Scope section or the interactive pdf eAF. |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 23910 | Human Variations eAF | eAF allows only two signatories |
| 15504 | Human Variations eAF | Deleted product package details are still appearing in Proposed changes section |
| 29109 | Human Variations eAF | Improve communication – ‘news’ tile on homepage |
| 29121 | Human Variations eAF | Improve communication – guidance and support page |
| 35130 | Human Variations eAF | Improve communication – change guidance documentation on login page from IRIS to PLM Portal |
| 26157 | Human Variations eAF | Packages missing in UAT which are in Production |
| 26203 | Human Variations eAF | Number of selected packages are not updated correctly |
| 23910 | Human Variations eAF | Inconsistent button behaviour by viewing 'selected packaged medicinal product(s)' |
| 24816 | Human Variations eAF | Validation error in product selection is incorrectly showing up if ‘Validation’ is pressed immediately after Saving |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23896 | Human Variations eAF | Error after wrong date format for Implementation date |
| 23912 | Human Variations eAF | Menu handling checkbox - Additional information does not disappear where it should have |
| 23913 | Human Variations eAF | Precise Scope & Background Info Pop-Up |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23966 | Human Variations eAF | Not possible to paste an image to the Present and Proposed fields in the Present and Proposed Value(s) tab |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23969 | Human Variations eAF | Cannot select more than one organisation in Proposed Organisation field |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24905 | Country name shown is long version in PDF | |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
| 25301 | Human Variations eAF | Precise scope and background for information section not saved |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 24731 | Human Variations eAF | The Proposed Package Item Content is not linked to Application Form |
Version: 1.0.1.3 (Release date 12/12/2022)
Version Goal: Go-Live PLM Portal
Date: 12/12/2022
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.3 | This release note is for the BUGFIX version 1.0.1.3 release go-live 12/12/2022 |
Issues fixed in this version
| ID | Description | Comments |
| 23987 – web eAF | Grouped variations including line extension | It is now possible to indicate that the variation contains a line extension also for those variations where only a single scope is selected. |
| 27565 – web eAF | 3 new tick boxes related to personal data are missing from the Declaration section when SPC, PI or labelling is ticked in Annexed documents section. | The mandatory tick boxes are now available in Declaration section when expected and no validation error is displayed. |
| 22013 – web eAF | Updated text for the 'no address change' in the declaration in present and proposed section | The text in the web eAF has been aligned to correspond with the updated text as per pdf eAF release on 14th October 2022. The text now reads ‘I declare this variation does NOT result in any changes in manufacturers (i.e. name/address change, addition or replacement of manufacturing site) or the Marketing Authorisation Holder. This update was done to ensure the correct use of the section – for any change that concerns an organisation e.g. change of a manufacturing site, the site must be selected from OMS. For further details on the use of this section please see: European Medicines Agency practical guidance on the application form for centralised type IA and IB variations page 13 |
| 22571 – web eAF | Medical Device: Manufacture of the device and Notified Body should be optional | The Manufacturer and the Notified body fields are now optional. |
| 24810 – web eAF | Email template populate incorrectly after sending notification to co-author from different organisation | The correct notification template is now sent by the system when sent by the user. |
| 25511 | Fix typos on homepage | Typos of the PLM Portal homepage have been fixed |
| 24533 – web eAF | Update Chatbot content and Look & Feel | The chatbot reflects the latest guidance content. |
| 25435 – web eAF | Change internal chatbot div, css and js code | The chatbot is no longer obscuring text on the form/PLM portal. |
Known issues
| ID | Component | Short description |
| Known limitation | PLM Portal | Copy application feature not available yet |
| Known limitation | Human Variations eAF | It is not possible to change the ‘Friendly name’ |
| Known limitation | Human Variations eAF | Form cannot be used for variations that add new presentation |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| Known limitation | Human Variations eAF | Cannot clone variation scopes added in the form (convenience feature when adding multiple times the same scope) |
| Known limitation | FHIR xml | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection/has only limited procedures available for some products. Workaround: use the +Add to manually add other ongoing applications |
| 22398 | Human Variations eAF | Present and Proposed section: ASMF number and DUNS number fields missing from the Web UI. Workaround: If these need to be provided, please use Precise Scope section or the interactive pdf eAF. |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 23910 | Human Variations eAF | eAF allows only two signatories |
| 23910 | Human Variations eAF | Inconsistent button behaviour by viewing 'selected packaged medicinal product(s)' |
| 24816 | Human Variations eAF | Validation error in product selection is incorrectly showing up if ‘Validation’ is pressed immediately after Saving |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23896 | Human Variations eAF | Error after wrong date format for Implementation date |
| 23912 | Human Variations eAF | Menu handling checkbox - Additional information does not disappear where it should have |
| 23913 | Human Variations eAF | Precise Scope & Background Info Pop-Up |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23966 | Human Variations eAF | Not possible to paste an image to the Present and Proposed fields in the Present and Proposed Value(s) tab |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23969 | Human Variations eAF | Cannot select more than one organisation in Proposed Organisation field |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24905 | Country name shown is long version in PDF | |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
| 25301 | Human Variations eAF | Precise scope and background for information section not saved |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 24731 | Human Variations eAF | The Proposed Package Item Content is not linked to Application Form |
Version: 1.0.1.2 (Release date 28/11/2022)
Version Goal: Go-Live PLM Portal
Date: 28/11/2022
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.2 | This release note is for the BUGFIX version 1.0.1.2 release go-live 28/11/2022 |
| Implementation of the human readable pdf export | PDF Version 2.0.2 | This release note is for the BUGFIX version 2.0.2 release go-live 28/11/2022 |
Issues fixed in this version
| ID | Description | Comments |
| 27878 – FHIR XML | Dissonance between the packaged products selected on the DADI form and the ones in the FHIR Message (XML) | Although the selected Medicinal Products were taken into account in the PDF, the packaged products weren't listed correctly. This fix is visible in the PDF version 2.0.2. There is no change to FHIR version. |
| 23407 – web eAF | Text is cut into two halves and displaying below | In the procedural information section the text ‘annual variation for human influenza vaccines’ was cut in the middle of the word influenza. |
Known issues
| ID | Component | Short description |
| 27565 | Human Variations eAF | 3 new tick boxes related to personal data are missing from the Declaration section when SPC, PI or labelling is ticked in Annexed documents section. This causes a validation error at time of finalisation of the form. Note: This does not result in business validation error as this is a known bug in the form. |
| Known limitation | PLM Portal | Copy application feature not available yet |
| Known limitation | Human Variations eAF | Cannot select ‘includes line extension’ when single scope added |
| Known limitation | Human Variations eAF | It is not possible to change the ‘Friendly name’ |
| Known limitation | Human Variations eAF | Form cannot be used for variations that add new presentation |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| Known limitation | Human Variations eAF | Cannot clone variation scopes added in the form (convenience feature when adding multiple times the same scope) |
| Known limitation | FHIR xml | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | Human Variations eAF | Present and Proposed section: ASMF number and DUNS number fields missing from the Web UI. If these need to be provided, please use Precise Scope section or the interactive pdf eAF. |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 23910 | Human Variations eAF | eAF allows only two signatories |
| 23910 | Human Variations eAF | Inconsistent button behavior by viewing 'selected packaged medicinal product(s)' |
| 24816 | Human Variations eAF | Validation error in product selection is incorrectly showing up if ‘Validation’ is pressed immediately after Saving |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23896 | Human Variations eAF | Error after wrong date format for Implementation date |
| 23912 | Human Variations eAF | Menu handling checkbox - Additional information does not disappear where it should have |
| 23913 | Human Variations eAF | Precise Scope & Background Info Pop-Up |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23966 | Human Variations eAF | Not possible to paste an image to the Present and Proposed fields in the Present and Proposed Value(s) tab |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23969 | Human Variations eAF | Cannot select more than one organisation in Proposed Organisation field |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24810 | PLM Portal | Email template populate incorrectly after sending "Notify" email to co-author |
| 24905 | Country name shown is long version in PDF | |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
| 25301 | Human Variations eAF | Precise scope and background for information section not saved |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 24731 | Human Variations eAF | The Proposed Package Item Content is not linked to Application Form |
Version: 1.0.1.1 (Release date 14/11/2022)
Version Goal: Go-Live PLM Portal
Date: Variation eAF 14/11/2022, PDF 17/11/2022, FHIR XML 16/11/2022
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.1.1 | This release note is for the BUGFIX version 1.0.1.1 release go-live 14/11/2022 |
| Implementation of the human readable pdf export | PDF Version 2.0.1 | This release note is for the BUGFIX version 2.0.1 release go-live 17/11/2022 |
| Implementation of the FHIR xml | FHIR XML 1.0.2.0 | This release note is for the BUGFIX version 1.0.2.0 release go-live 16/11/2022 |
Issues fixed in this version
| ID | Description | Comments |
| 24816 – web eAF | RPI cannot be blank validation message is displaying always when CAP product is selected | Remaining known issue: Validation error in product selection is incorrectly showing up if ‘Validation’ is pressed immediately after Saving. This issue has been partly fixed; the incorrect list was linked to the products resulting RPI validation issue for every product. This part of the issue has been addressed. |
| 24731 – web eAF | The Proposed Package Item Content is not linked to Application Form | The Proposed Package Item Content created when Present Package Item Content doesn't exist and has no link to Application Form and Application Form Type. Hence these records are not available for FHIR XML creation and doesn't reach PDF. |
| 24728 – web eAF | Update Chatbot look and feel | |
| 24649 – web eAF | Additional information section is displaying as completed without validate/export | Additional information section was automatically changed to ‘completed’ status when it was not filled in/validated by the user. After the bugfix the additional information section remains in ‘not completed’ state until the user manually validates the section |
| 24819 – web eAF | PDF export is taking long time and loading is displaying for long time | This issue was affecting forms where there were more than 10 medicinal products selected. |
| 24991 – web eAF | Medical device is displaying proposed changes without click on save | Medical device section was displayed even when the user clicked ‘cancel’ button and no changes were made and no save button was pressed. |
| 24703 – web eAF | Incorrect date sorting for Export window | The list of pdf exports was displayed in random order. |
| 24805 – web eAF | Prompt message on ‘Delete device’ | Issue relating to ‘Delete device’ button has been fixed. |
| 24924 – web eAF | Validation button is not working in all sections | Validate button was not working correctly in all sections. |
| 24990 – web eAF | Validation error message is displayed in proposed changes section after combining scopes and packaged medicinal products | Scrambled validation error message is not be shown when scope and product combinations are updated. |
| 26295 – FHIR XML | The HTML Change Provenance (unstructured provenance) doesn't contain the HTML changes when the proposed value and the present value are the same | This issue resulted a missing present and proposed section in the FHIR XML and in the pdf export when same value was presented in both ‘present’ and ‘proposed’ fields e.g. if user had added ‘see details on separate annex’ in both fields, the present and proposed sections were not available in the xml and were hidden in the pdf. |
| 26247 – FHIR XML | Impossible to use the same image twice in the text areas in a form | |
| 22013 - pdf | Updated text for the 'no address change' in the declaration in present and proposed section | The text has been aligned to correspond with the updated text as per pdf eAF release on 14th October 2022. The text now reads ‘I declare this variation does NOT result in any changes in manufacturers (i.e. name/address change, addition or replacement of manufacturing site) or the Marketing Authorisation Holder. This update was done to ensure the correct use of the section – for any change that concerns an organisation e.g. change of a manufacturing site, the site must be selected from OMS. For further details on the use of this section please see: European Medicines Agency practical guidance on the application form for centralised type IA and IB variations page 13 |
| 24738 – pdf |
| The appendix part of pdf was deleted as non-relevant. The changes are now reflected in the present and proposed section where relevant e.g. ATC code. The text size in Precise scope and Background sections and the Present and Proposed fields is now same size as in all other fields in the pdf making the form content easier to read. |
Known issues
| ID | Component | Short description |
| 27565 | Human Variations eAF | 3 new tick boxes related to personal data are missing from the Declaration section when SPC, PI or labelling is ticked in Annexed documents section. This causes a validation error at time of finalisation of the form. Note: This does not result in business validation error as this is a known bug in the form. |
| Known limitation | PLM Portal | Copy application feature not available yet |
| Known limitation | Human Variations eAF | Cannot select ‘includes line extension’ when single scope added |
| Known limitation | Human Variations eAF | It is not possible to change the ‘Friendly name’ |
| Known limitation | Human Variations eAF | Form cannot be used for variations that add new presentation |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| Known limitation | Human Variations eAF | Cannot clone variation scopes added in the form (convenience feature when adding multiple times the same scope) |
| Known limitation | FHIR xml | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | Human Variations eAF | Present and Proposed section: ASMF number and DUNS number fields missing from the Web UI. If these need to be provided, please use Precise Scope section or the interactive pdf eAF. |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 23910 | Human Variations eAF | eAF allows only two signatories |
| 23910 | Human Variations eAF | Inconsistent button behavior by viewing 'selected packaged medicinal product(s)' |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working – Using ‘delete application form’ in the deactivated folder results the deactivated form being moved back to ‘Drafts’ |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23896 | Human Variations eAF | Error after wrong date format for Implementation date |
| 23912 | Human Variations eAF | Menu handling checkbox - Additional information does not disappear where it should have |
| 23913 | Human Variations eAF | Precise Scope & Background Info Pop-Up |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23966 | Human Variations eAF | Not possible to paste an image to the Present and Proposed fields in the Present and Proposed Value(s) tab |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23969 | Human Variations eAF | Cannot select more than one organisation in Proposed Organisation field |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24810 | PLM Portal | Email template populate incorrectly after sending "Notify" email to co-author |
| 24905 | Country name shown is long version in PDF | |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
| 25301 | Human Variations eAF | Precise scope and background for information section not saved |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
Version: 1.0.0.0 (Release date 04/11/2022)
Version Goal: Go-Live PLM Portal
Date: 04/11/2022
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the Product Lifecycle Management Portal | PLM Portal | This implementation is the first version of the portal |
| Implementation of the web based human variation application form | Human Variations eAF Version 1.0.0 | This implementation is the first version of the web-based form for human variations based on the NTA APPLICATION FOR VARIATION TO A MARKETING AUTHORISATION, September 2021 |
| Implementation of the human readable pdf export | PDF Version 2.0.0 | This implementation is the first version of the pdf rendition export |
| Implementation of the FHIR xml | FHIR XML 1.0.0 | This implementation is the first version of the FHIR xml export |
Known issues
| ID | Component | Short description |
| Known limitation | PLM Portal | Copy application feature not available yet |
| Known limitation | Human Variations eAF | Cannot select ‘includes line extension’ when single scope added |
| Known limitation | Human Variations eAF | It is not possible to change the ‘Friendly name’ |
| Known limitation | Human Variations eAF | Form cannot be used for variations that add new presentation |
| Known limitation | Human Variations eAF | Delay in display of packaged medicinal products in product selection. |
| Known limitation | Human Variations eAF | Delay in automated calculations in Procedural information section e.g. correct calculation of ‘grouping’ or display of Additional Information section |
| Known limitation | Human Variations eAF | Cannot clone variation scopes added in the form (convenience feature when adding multiple times the same scope) |
| Known limitation | FHIR xml | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
| Known limitation | Human Variations eAF | The system creates an empty row in summary of Present and Proposed when ‘save’ is pressed after filling in certain sections. The empty row should be edited to contain the changes or deleted |
| Known limitation | Human Variations eAF | Other Applications – Select EMA Procedure has no related procedures available for selection. Workaround: use the +Add to manually add other ongoing applications |
| Known limitation | Human Variations eAF | Present and Proposed section: ASMF number and DUNS number fields missing from the Web UI. If these need to be provided, please use Precise Scope section or the interactive pdf eAF. |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 23910 | Human Variations eAF | eAF allows only two signatories |
| 23910 | Human Variations eAF | Inconsistent button behavior by viewing 'selected packaged medicinal product(s)' |
| 24816 | Human Variations eAF | Validation error in product selection is incorrectly showing up if ‘Validation’ is pressed immediately after Saving |
| 16209 | Human Variations eAF | Symbol "?" is displaying in font style drop down |
| 22733 | Human Variations eAF | Error for product and scope selection, package check box is disabled |
| 22845 | PLM Portal | Deletion of Application Form is not working |
| 23545 | PLM Portal | Performance issues |
| 23849 | Human Variations eAF | Annexed Documents Section: External links in the help text referring to notice to applicant cannot be selected easily |
| 23851 | Human Variations eAF | Search on present-proposed disappearing |
| 23896 | Human Variations eAF | Error after wrong date format for Implementation date |
| 23912 | Human Variations eAF | Menu handling checkbox - Additional information does not disappear where it should have |
| 23913 | Human Variations eAF | Precise Scope & Background Info Pop-Up |
| 23915 | Human Variations eAF | Organisation information - parent organisation label does not match |
| 23923 | Human Variations eAF | Drop down list member state country doesn't open - intermittent |
| 23931 | Human Variations eAF | Double-clicking Save button for Change(s) Scope creates duplicates |
| 23961 | PLM Portal | Drop-down invisible in Application Forms overview |
| 23963 | Human Variations eAF | Changes Implementation Date issue |
| 23963 | Human Variations eAF | Finalisation: Statement in Annexed document and Declaration Section in random order in DADI |
| 23965 | Human Variations eAF | Conditions and documentation in DADI are not in the same order as in the variation classification guideline |
| 23966 | Human Variations eAF | Not possible to paste an image to the Present and Proposed fields in the Present and Proposed Value(s) tab |
| 23967 | Human Variations eAF | Finalisation section - Proof of payment - able to select either Yes or NO |
| 23968 | Human Variations eAF | Hyphenations are incorrect in tab type of changes, in the view scope and description and in the view conditions and documentation section |
| 23969 | Human Variations eAF | Cannot select more than one organisation in Proposed Organisation field |
| 23971 | Human Variations eAF | Proposal for Organisation Details – Split Text |
| 23974 | Human Variations eAF | Suggestion - Scope section - Information is not displayed in a user-friendly manner. |
| 24006 | PLM Portal | Refresh button producing error on Application list view |
| 24810 | PLM Portal | Email template populate incorrectly after sending "Notify" email to co-author |
| 24905 | Country name shown is long version in PDF | |
| 24907 | Human Variations eAF | Select all checkbox does not "Select All" in "Proposed Changes" section |
| 25269 | Human Variations eAF | Product select screen shows 0/0 product presentation |
| 25301 | Human Variations eAF | Precise scope and background for information section not saved |
| 25395 | Human Variations eAF | Some inactive organisations from OMS available in Contact Person organisation section |
| 25396 | Human Variations eAF | Packaged medicinal products are not shown when combining scopes and medicinal products |
| 25400 | Human Variations eAF | Incorrect calculation of number of selected scopes in the summary page |
| 24731 | Human Variations eAF | The Proposed Package Item Content is not linked to Application Form |