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Updated on: 06 May 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:
 

ComponentShort Description
 
PLM PortalThis component relates to the website, the UI (user interface)
Human Variations eAFThe business process where MAH’s create and edit their variation eAF (electronic application form) on the PLM Portal
PDFThe PDF that is available for download after the completion of an application
FHIR XMLThe FHIR xml file attached to exported PDF

 

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

 


For additional information on the PLM portal:

 

 

 

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 caseComponentDescription
Implementation of the FHIR XMLFHIR XML
1.2.0		Commercially Confidential Data not related to the application content/variation removed from the FHIR XML


Issues fixed in this version

IDDescriptionComments
38300, 15895, 46485Identify 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

  1. Only Resources that are needed for the PDF are also contained in the XML.
  2. Confidential data is not included when not needed.

 
Paradigm
Rule Nr.1: If a resource has a change to 1 property the entire resource needs to be there. 
Rule Nr.2: If a resource has a link to a resource that is not being changed, the link should stay, but the resource that is being linked should not be there. This is to be able to compare resources and confirm that something/nothing has changed.
Rule Nr.3: Resources pointed at by the Task should always be mandatory.
 
Mandatory resources (always included, irrespective if they are being changed): 

  • Medicinal ProductDefinition
  • IngredientDefinition
    • Reason: Substance Name
    • implicit: Link to medicinal product (extension) - not Admin product link
    • Role = Active
  • RegulatedAuthorization - for selected packages and med products (Type=Marketing Authorization)
  • PackagedProductDefinition - ONLY IF SELECTED
  • All Orphan Resources
  • Orphan RAs, GMP RAs, Paediatric RAs, Market Exclusivity and Market Protection RAs
  • Organization (type=MA Holder and Regulator - linked to the RegulatedAuthorization)
  • All parallel resources (MedicinalProductDefinition + RA)
  • Substances (role = active)
  • PaymentNotices
  • PractitionerRole and its organizations

 
Subtasks/Scopes, which are represented as FHIR Tasks, will no longer be contained resources, but flattened *
Previous implementation: "/f:Bundle/f:entry/f:resource/f:Task/f:contained/f:Task"
Adjustment: "/f:Bundle/f:entry/f:resource/f:Task"
 
Suggestion for consuming systems using XPATH
//Task[id/@value=substring-after($reference,'#')]|//Task[id/@value=substring-after($reference,'Task/')]
 
* See detailed picture below
 


Old paradigm(Task represented in orange and Scope represented in Yellow):
 
New Paradigm(Task represented in orange and Scope represented in Yellow):




Known Issues

IDComponentShort description
n/an/an/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 caseComponentShort description
Implementation of the FHIR XMLFHIR XML
1.1.2		 


Issues fixed in this version

IDDescriptionComments
36110ASMF, DUNS Nr, Telephone and Email changesChange ASMF, DUNS Nr, Telephone and Email mapping in FHIR according to the changes in the eAF
24565Free text field changesLimit width of free text fields
30382/30383/30387Various refactoringIngredient/Ingredient Strength/Ingredient Documentation FHIR refactoring
38537Device DefinitionAttach every DeviceDefinition to a Medicinal Product
38779ATC Source IDAdd the Source ID to the ATC while keeping the ATC name as well
37124/38274Device variationMinor fixes to the Device variation as new edge-cases were tested


Known Issues

IDComponentShort description
38300FHIR XMLCommercially 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 caseComponentShort description
Implementation of the FHIR XMLFHIR 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

IDDescriptionComments
26295 – FHIR XMLThe HTML Change Provenance (unstructured provenance) doesn't contain the HTML changes when the proposed value and the present value are the sameThis 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 XMLImpossible to use the same image twice in the text areas in a form 


Known Issues

IDComponentShort description
Known limitationFHIR XMLCommercially 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 caseComponentShort description
Implementation of the FHIR XMLFHIR XML
1.0.0		This implementation is the first version of the FHIR XML export

 

Known Issues

IDComponentShort description
Known limitationFHIR XMLCommercially Confidential Data not related to the application content/variation present in the FHIR XML



 

Keywords: eAF, FHIR, release notes