Updated on: 01 July 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.
This document lists and briefly describes the new features and fixed issues included in the release of the PLM Portal FHIR XML only. For the Release notes related to the eAF, please visit the guidance on 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 FHIR XML only.
For the Release notes related to the eAF, please visit the guidance on the PLM Portal.
The most recent release appears first.
The components mentioned in this document 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 |
FHIR Package:
The latest FHIR mapping (starting with version 2.2.3) can be found here: PLM Portal eAF FHIR Package (Mapping) 2.2.3, and it can be read together with the package: PLM Portal eAF FHIR XML Package 2.0.0/2.1.0
For additional information on the PLM portal:
PLM Portal: PLM Portal
If you encounter any issue that is not addressed by the above, visit the EMA Service Desk portal
For more general information, visit: PLM Portal eAF
Version 2.2.3 (Release date: 30/06/2025)
Version Content
The version 2.2.3 introduces the following non-breaking changes:
• There’s a new extension in (sub)Task.code.coding[system=https://spor.ema.europa.eu/v1/lists/100000152091].extension[system=http://ema.europa.eu/fhir/termName].valueString containing the full name of the scope. For example: “B.II.e.7.a Deletion of a supplier”, instead of “B.II.e.7.a”
• The DataCarrierIdentifier identifier was moved from PackagedProductDefinition.package.identifier to PackagedProductDefinition.identifier
The next upgrade of the PLM Portal FHIR XML (2.2.4) is currently planned for the end of July 2025, and the date will be confirmed in due time. The version 2.2.4 will introduce a change on the HTTP protocol of the links referenced in the FHIR message. The recommended FHIR protocol is HTTP, therefore all the links currently using HTTPS will be changed to HTTP.
Version 2.2.2 (Release date: 13/05/2025)
Version Content
The version 2.2.2 introduces the following change: there is a new element in the Organisation, called “alias”, which contains (if existing) the selected alternative company name:
<alias value="alternative company/organisation name" />
Version 2.2.1 (Release date: 14/02/2025)
Version Content
The version 2.2.1 introduces the following change: the <meta> node will contain a new profile value (<profile value=http://ema.europa.eu/fhir/definition/fhir-export /2.2.1.0 />) and the "Bundle-variation" will lose the 4th digit in the XML.
FHIR Package:
The latest FHIR mapping (starting with version 2.1.1.) can be found here: PLM Portal eAF FHIR Package (Mapping) 2.1.1, and it can be read together with the package: PLM Portal eAF FHIR XML Package 2.0.0/2.1.
Version 2.2.0 (Release date: 07/01/2025)
Version Content
The version 2.2.1 introduces the following change: the <meta> node will contain a new profile value (<profile value=http://ema.europa.eu/fhir/definition/fhir-export /2.2.1.0 />) and the "Bundle-variation" will lose the 4th digit in the XML.
FHIR Package:
The latest FHIR mapping (starting with version 2.1.1.) can be found here: PLM Portal eAF FHIR Package (Mapping) 2.1.1, and it can be read together with the package: PLM Portal eAF FHIR XML Package 2.0.0/2.1.
Version 2.1.1 (Release date: 09/12/2024)
Version Content
The version 2.1.1 introduces several changes from the previously published package. The differences are detailed below:
Variation changes (FHIR 5.0.0 column):
- New note field for the Declaration of the applicant (line 183 in the “PLM Portal eAF FHIR Package (Mapping) 2.1.1”, “Variation” tab, published on the eSubmission website)
- The cardinality of the unstructured changes was upgraded from 1 to N (line 72 and 73 in the “PLM Portal eAF FHIR Package (Mapping) 2.1.1”, “Variation” tab, published on the eSubmission website)
FHIR Package:
The latest FHIR mapping (starting with version 2.1.1.) can be found here: PLM Portal eAF FHIR Package (Mapping) 2.1.1, and it can be read together with the package: PLM Portal eAF FHIR XML Package 2.0.0/2.1.0
Version 2.1.0 (Release date: 28/10/2024)
Version Content
The version 2.0.1 was updated to 2.1.0 on the 28th of October because the underlying .NET version was upgraded from .NET6 to .NET8.
The previously package is still valid and can be found here.
Version 2.0.1 (Release date: 28/06/2024)
Version Content
The version 2.0.1 introduces several changes from the previously published package. The differences are detailed below.
Medicinal Product changes (FHIR 5.0.0 column):
- MP9-MPD20 (see example in MedicinalProductDefinitionWithAllFieldsForPermissiveTestingV5.xml) – Legal Status Of Supply new mappings
- PPD10 (see example in PackagedProductDefinitionWithAllFieldsForPermissiveTestingV5.xml) - include the extension’s url (codedUnit) and fix domain resource example
- PPD13-PPD23 (see example in PackagedProductDefinitionWithAllFieldsForPermissiveTestingV5.xml) – Legal Status Of Supply new mappings
- PPD29 – The PackagedProductDefinition.description field is now optional (it was mandatory)
- CUD1, CUD2, CUD3 & CUD4 (see ClinicalUseDefinitionWithAllFieldsForPermissiveTestingV5.xml)
Variation changes (FHIR 5.0.0 column):
- RA1: the applicationIdentifierNumber in the marketing regulated authorization is now labelled mrpVariationNumber
- RA7 (see RegulatedAuthorizationWithAllFieldsForPermissiveTestingV5.xml) – This reverts it to ‘http://ema.europa.eu/fhir/extension/overviewTable’ instead of just ‘overviewTable’
- RA8 (every RegulatedAuthorization example and Full App) – the list ID 100000160962 (mistake) was replaced by the 100000000002 one
Improvements in the examples:
Full App Example:
- Mandatory strength was added to every Ingredient
- A packaging and a containedItemQuantity were added to every PackagedProductDefinition
- All countries are now presented with their short name: Portugal instead of Portuguese Republic. It was changed, where needed, in RegulatedAuthorization.region.coding.display
Ingredient Examples:
- the denominator’s list was incorrectly 100000110633. It was updated to 200000000014.
The updated package can be found here.
Version 2.0.0 (Announcement date: 31/01/2024 - Release date: 14/06/2024)
Version Goal
We are eager to announce the upgrade of the eAF human variation FHIR XML version 2.0.0 that includes the latest official FHIR version “Release #5 (5.0.0): http://hl7.org/fhir". This replaces the current version FHIR Release #5: Draft Ballot (4.6.0): http://hl7.org/fhir/2021May/, which will remain online for approximately 3 months to give consuming systems time to adapt to the change.
Version Content
The upgrade of the eAF XML to the current official Release #5 of FHIR is the first part of EMAs strategy to synchronize different projects on a stable FHIR version that will provide the necessary stability in the network to implement the new data exchange format on a larger scale.
Together with the upgrade to Release #5, we have reviewed and improved the eAF mappings in FHIR in order to provide the most stable version yet for consuming systems to start importing the eAF.
What this is not
This release note will enable consuming systems to read the message and extract the necessary data. It is not a documentation to create the message itself. The necessary Guide to create an eAF FHIR message is being worked on and will be published at a later stage.
How to read the release documentation?
To provide consumers of the FHIR XML message the easiest possible way to upgrade to the eAF XML 2.0.0.0 containing the new FHIR #5 resources or to start your implementation with the latest version, we have prepared*:
- A change log: 2024 01 30 Changelog eAF Variation FHIR 4.6 to 5.0.xlsx This contains an extensive list of all changes done in the new eAF XML version with links to the data requirements, 4.6 Paths, 5.0 Paths and the reason for change
- A snapshot of the current eAF data requirements: 2024 01 30 AF Data Requirements.xlsx This contains all fields for variation and medicinal product being used now or in future versions of the PLM portal
- All resources in v4.6 and v5.0 as XML for an easy comparison usable for permissive testing: MedicinalProduct Domain Resources - 4.6 and 5.0, Variation Domain Resources - 4.6 and 5.0 A complete list of examples for every resource in both versions to easily compare the changes and understand how the new structure looks like
- As complete as possible examples of an invented variation message exported in 4.6 and 5.0 from the PLM portal: eAF human variation 4.6.0 - 1.2.0.8.xml, eAF human variation 5.0.0 - 2.0.0.0.xml An example was created of a complete bundle that was filled in with a focus on completeness rather than realistic data. This is to be used to understand how the different resources behave in the bundle.
*The documents can be found here.
Version 1.2.0 (Release date: 21/11/2023)
Version Goal: Implementation of FHIR XML
Date: 21/11/2023
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Description |
| Implementation of the FHIR XML | FHIR XML 1.2.0 | Commercially Confidential Data not related to the application content/variation removed from the FHIR XML |
Issues fixed in this version
| ID | Description | Comments |
| 38300, 15895, 46485 | Identify minimum set of fields required to export and update FHIR generation to exclude information not needed | Removing Product data that has not been changed in the FHIR XML
|
Old paradigm(Task represented in orange and Scope represented in Yellow):
New Paradigm(Task represented in orange and Scope represented in Yellow):
Known Issues
| ID | Component | Short description |
| n/a | n/a | n/a |
Version 1.1.2 (Release date: 10/02/2023)
Version Goal: Implementation of FHIR XML
Date: 10/02/2023
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the FHIR XML | FHIR XML 1.1.2 |
Issues fixed in this version
| ID | Description | Comments |
| 36110 | ASMF, DUNS Nr, Telephone and Email changes | Change ASMF, DUNS Nr, Telephone and Email mapping in FHIR according to the changes in the eAF |
| 24565 | Free text field changes | Limit width of free text fields |
| 30382/30383/30387 | Various refactoring | Ingredient/Ingredient Strength/Ingredient Documentation FHIR refactoring |
| 38537 | Device Definition | Attach every DeviceDefinition to a Medicinal Product |
| 38779 | ATC Source ID | Add the Source ID to the ATC while keeping the ATC name as well |
| 37124/38274 | Device variation | Minor fixes to the Device variation as new edge-cases were tested |
Known Issues
| ID | Component | Short description |
| 38300 | FHIR XML | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
Version 1.0.2 (Release date: 16/11/2022)
Version Goal: Implementation of FHIR XML
Date: 16/11/2022
Environment: production
Version content (testable functionalities/use cases)
Version content
| Functionality/use case | Component | Short description |
| Implementation of the FHIR XML | FHIR XML 1.0.2 | This release note is for the BUGFIX version 1.0.2 release go-live 16/11/2022 |
Issues fixed in this version
| ID | Description | Comments |
| 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 |
Known Issues
| ID | Component | Short description |
| Known limitation | FHIR XML | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |
Version 1.0.0 (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 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 | FHIR XML | Commercially Confidential Data not related to the application content/variation present in the FHIR XML |