Release Notes

SPORIFY Roadmap

Version 2027.1 (Preview)

Version 2027.1 will follow the SPORIFY 2026.2 release. Detailed release notes and validation documentation will be published 10 days before validation begins. New features will include:

Addition of Health Canada, PQCMC and SPL Referentials

In addition to renewing the architecture of Referentials, Target records Health Canada and the FDA will be made available to users in SPORIFY, allowing customers to map their source data to Canadian and US FDA target systems.

Version 2026.1 Hotfix #1

Release Date: 2026-09-12

This hotfix focuses on adapting to the new SPOR RMS service in order to continue synchronisation for all data elements. In addition overall system stability is being improved to avoid outages on RMS synchronisation failures.

Bug Fixes

SPRFY-5649 - RMS Sync is unable to access and process anytext term summary api

Bug Fix: With the newest SPOR RMS deployment a search using the parameter "Anytext" is now available for internal EMA use only. SPORIFY was adapted to fetch the term summaries without this parameter. This will result in the term summary APIs resuming to provide updated information and increase overall system stability as the synchronisation is no longer failing for aforementioned data queries in RMS.

Impacted Areas: Referentials, Synchronisation

Regression Areas: Referentials, Synchronisation

Impact on Configurations: No

SPRFY-5319 - #38510 Discrepancy in the Product Data Between SPORIFY and PMS

Bug Fix: A defect has been resolved where product data displayed in SPORIFY sometimes differs from the source data held in PMS due to authorisation data being incorrectly sourced from an orphan designation rather than the Marketing Authorisation. The PMS synchronisation logic has been updated to prioritise the Marketing Authorisation (type code 220000000061) when multiple regulated authorisation records exist for a Product. Existing product records will be corrected upon the next product version change in PMS.

Impacted Areas: Target Products

Regression Areas: Target Products

Impact on Configurations: No

Version 2026.2

Release Dates:

Validation Environment: 2026-09-29

Production Environment: 2026-12-12

Requirements

Extend Product Module

SPRFY-4651 - Extend Product Module to Contain Source ID, Country, and MA Number: Source Products

Requirement: The Product module in SPORIFY has been expanded to display the product's Source ID, Country, and MA Number for Source Products. This enhancement enables users to easily identify products originating from their RIM system directly in SPORIFY, improving traceability and cross-system product identification.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-4889 - Extend Product Target List With Existing Attributes

Requirement: The Products Target List has been enhanced to display richer identifying attributes for each entry, addressing the limited search capabilities of the PLM portal. The Pharmaceutical Form column now includes an inline RMS ID with a hyperlink to the corresponding RMS Term Details Page; the Marketing Authorisation Holder (MAH) column displays an inline LOC ID with a link to the Organisation Details Page; and the Active Substance column shows an inline Substance Code with a link to the SMS Details Page.

Impacted Areas: Target Products

Regression Areas: Target Products

Impact on Configurations: No

SPRFY-5052 - Extend Product Target List with New Attributes

Requirement: The Product Target List in the PLM portal has been enhanced with additional identifying attributes, making it easier for users to locate and differentiate Products. Previously, the Target List displayed limited information, requiring users to rely on the portal's basic search functionality. With this update, the Procedure Type and Record Status are now included in the Target List, improving discoverability and streamlining Product selection workflows.

Impacted Areas: Target Products

Regression Areas: Target Products

Impact on Configurations: No

SPRFY-5053 - Filter/Search in Product Module for Source ID, Country and MA Number

Requirement: In the Product module, users can now utilise the global search function for Source ID, MA Country, and MA Number. They can additionally filter products by Source ID, MA Country, and MA Number too. The new table columns are sortable and filterable, and they can be added or removed via the Preferences fly-out menu. These search and filter enhancements enable users to quickly identify and locate products originating from their RIM system, improving product traceability and streamlining workflows.

Impacted Areas: Source Products, Target Products

Regression Areas: Source Products, Target Products

Impact on Configurations: No

SPRFY-5173- Procedure Type Column Should be Searchable/Filterable/Sortable and it Should Be Added to Preferences

Requirement: The Procedure Type column in the Products module has been enhanced to support search, filter (multi-select), sort, and column preference management (reorder/hide), bringing it in line with the behaviour of all other columns in the grid. Users can now locate and organise records by Procedure Type with the same flexibility they have for existing columns, improving overall usability and consistency within the Product List View.

Impacted Areas: Target Products

Regression Areas: Target Products

Impact on Configurations: No

Enrich Veeva With PMS IDs

SPRFY-4680 - Create Veeva Loader File

Requirement: As part of the Veeva synchronisation workflow, Products are now updated with PMS IDs based on matches made in SPORIFY. When the ‘Enable Product Enrichment’ setting is activated, the system automatically exports a Veeva loader file containing the matched PMS ID during each manual or scheduled sync. Users can optionally limit enrichment to Products matching a specific Resolution Status using the ‘Limit Matched Data Included In Sync by Resolution Status for Products’ setting. All export files are saved to S3 and made available through the sync detail log for auditing and traceability purposes.

Impacted Areas: Veeva Integration & Synchronisation

Regression Areas: Veeva Integration & Synchronisation

Impact on Configurations: No

SPRFY-4681 - Veeva Sync Write Configuration for Products

Requirement: A new configuration option entitled ‘Enable Product Enrichment’ has been added to the system. When this configuration is enabled, Veeva users can opt to ‘Limit Matched Data Included in Sync By Resolution Status For Products’ and select a custom or default Resolution Status to which this setting should be applied. This addition provides users with greater control over the behaviour of the Veeva sync.

Impacted Areas: Veeva Integration & Synchronisation

Regression Areas: Veeva Integration & Synchronisation

Impact on Configurations: No

SPRFY-4682 - Veeva Sync Detail Log

Requirement: Users can now download export files directly from the Sync Details section of the Veeva Log. These exported CSV files follow the same format and structure as the RMS, OMS and SMS exports from the Veeva Loader, ensuring a consistent experience across all product sync workflows.

Impacted Areas: Veeva Integration & Synchronisation

Regression Areas: Veeva Integration & Synchronisation

Impact on Configurations: No

Enable Customer Facing Product API for 3rd Party Integration

SPRFY-4854 - Export Source Products as Excel

Requirement: Users can now export Products Source Lists as Excel files, making it easy for non-Veeva customers to extract the PMS IDs of matched Products and import them into their RIM system via files. The export captures all relevant Product information, including PMS IDs, and supports optional filtering to narrow down results before download.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-4855 - Export Source From API

Requirement: A new API endpoint (/api/source/source-lists/{listId}/products) is now available, enabling integrated external systems to programmatically retrieve all Products from a completed Source List along with their matched PMS IDs in JSON format. The endpoint supports pagination (page sizes from 10 to 200) and filtering by Resolution Status, and is secured under the Products parent permission (covering Source, Target, and Compare Products).

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-4885 - Comparison Report Via API

Requirement: A new API endpoint (/api/fhircomparison/{comparisonId}/export) that allows integrated systems to programmatically retrieve the Product Comparison Report has been introduced. The API returns the comparison results as an Excel file, enabling external systems to access and consume comparison data without relying on the SPORIFY UI. If the comparison ID is present but the comparison was not completed successfully, the API returns a ‘400 Bad Request’ response.

Impacted Areas: Product Comparison

Regression Areas: Product Comparison

Impact on Configurations: No

Insight into New Products

SPRFY-4874 - New 'Unmapped Product' Data Insight for Target Products

Requirement: A new 'Unmapped Product' data insight has been introduced for Target Products, enabling users to quickly identify Products that are not yet mapped to any Source List. The insight is displayed as an icon in the Info column, viewable via a hover state; it is automatically removed once the Product is mapped to at least one Source List Product and the page has been refreshed. The unmapped status is also included in the existing Target Product export alongside other data insights.

Impacted Areas: Target Products

Regression Areas: Target Products

Impact on Configurations: No

SPRFY-4875 - Filtering for the 'Unmapped Product' Data Insight

Requirement: Users can now filter by the 'Unmapped Products' data insight within Preferences: Advanced Search, making it easier to narrow down Target Lists to show only new or unmapped Products. This enhancement streamlines Product mapping workflows by allowing users to quickly isolate unmapped entries for review and action.

Impacted Areas: Target Products

Regression Areas: Target Products

Impact on Configurations: No

Upload Products Via Excel

SPRFY-4881 - Import Excel to Create Product Source List

Requirement: Users can now upload an Excel file to a Product Source List, in addition to the existing JSON and XML import options. The Excel file supports key Product fields, namely Source ID, PMS ID, Product Full Name, EV Code, RMS Code of the Authorisation Country, and MA Number. The system automatically processes the uploaded data, while built-in validation ensures the Source IDs are unique and mandatory fields are provided.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-4848 - Avoid Duplicate Products or Missing Required Fields

Requirement: The system now validates Products against existing Source IDs when users manually add a product, upload an Excel file, or submit FHIR messages to a Source List, preventing duplicate entries. If duplicates are detected, an error message is displayed indicating the count and listings of the duplicate Source IDs.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-4987 - Add One New Product to an Existing Source List with a UI Pop Up

Requirement: Users can now add a new Product to an existing Source List directly via a convenient UI pop-up. This can be accessed by clicking the Add Products button, eliminating the need to process FHIR messages or upload an Excel template for single-Product additions. This enhancement streamlines the manual Product entry workflow.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-5060 - Download the Template for the Product Excel Import

Requirement: Users can now download a pre-formatted Excel template for Product imports by clicking the Templates button located in the Products domain. The template contains columns for Source ID, PMS ID, Product Full Name, EV Code, RMS ID of Authorisation Country, and MA Numbers. This supports a streamlined data entry process by enabling users to populate Product data offline and upload it in a standardised format.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-5316 - Add New Products to an Existing Source List Via Excel

Requirement: Users can now add new Products in bulk to an existing Source List by uploading an Excel file directly from within the list using the "Add Products" button. The upload supports key fields including Source ID, PMS ID, Product Full Name, EV Code, RMS Country Code, and MA Numbers. Products can be added either via file upload or manual entry — when a file is selected, fields are auto-populated and non-editable, and vice versa. The system automatically initiates comparison for newly uploaded Products, enforces uniqueness on Source ID and PMS ID, and validates that all mandatory attributes are present before allowing the addition. This enhancement streamlines bulk Product onboarding by eliminating the need to process FHIR messages for multi-Product additions.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-5317 - Allow Unlimited Number of Products to Upload

Requirement: The previous limit of 500 Products per upload has been removed. Users can now upload an unlimited number of Products via a single ZIP file (containing FHIR-format JSON or XML files), a single FHIR JSON/XML file, or an Excel template, with the only constraint being the maximum file upload size of 20 MB.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-5318 - Enable Parallel Upload of Files to the Same List

Requirement: Users can now upload additional Product files to a source list while a matching or comparison process is already in progress, eliminating the previous blocking behaviour that prevented any interaction during processing. While an upload is running, the actions menu and list navigation remain accessible, though the "Delete" option is appropriately disabled to protect data integrity. The Source List report has also been enhanced to display all product additions as individual entries — rather than only the last upload — with a new "Updated" date/time column (sorted newest first) so users can easily track when each batch of products was added.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-5371 - Stop Comparison for Manual Product Creation

Requirement: Products added to a source list via Excel upload or manual entry through the "Add Product" UI will now display a new comparison status of "No FHIR message available," clearly indicating that no actual FHIR message exists for these products and that an automatic comparison will not be triggered. The Data Quality Insights and Export Comparison Report icons are hidden for products with this status, as they provide no meaningful value without a real comparison. Users can filter source list records by this new status using the existing Advanced Filters — Comparison Status dropdown. Manual comparison remains possible for these products via the Compare Products screen, as a basic FHIR message is generated by SPORIFY, though it is not recommended.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-5491 - Update Info Box to Be In Line With the Functionalities

Requirement: The informational pop-ups displayed when adding Source Lists or Products have been updated to accurately reflect the current supported upload formats. The previously stated 500-file limitation has been removed, and the pop-ups now clearly indicate that users can upload a single ZIP file (up to 20 MB) containing individual FHIR files in JSON or XML format (one per Product), a single FHIR file in JSON or XML format (up to 20 MB) containing one Product, or an Excel file with multiple Products (up to 20 MB).

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

Product Matching on MA Number

SPRFY-4652 - Augment Product Matching with MA Number

Requirement: Product matching has been enhanced to support matching on MA Numbers in addition to textual Product Names. The system now follows an expanded mapping sequence — PMS ID, EV Code, MA Number, and Exact Name — enabling more accurate and reliable product identification. Combined MA Numbers and combined MA Package Numbers are also supported, matching against either the EU Number (at the product level) or the MA Number (at the product or package level) of the Target Product.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-5020 - Split and Save MA Numbers

Requirement: SPORIFY newly supports the splitting and saving of Marketing Authorisation (MA) Numbers. NCA users can now view a comprehensive listing of all MA Numbers associated with specific Products and Packages directly in their Product records. This enhancement streamlines Product identification and improves data visibility within the SPORIFY Products module.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-5022 - More Information on Matching

Requirement: The Product matching view has been enhanced to display additional identifying details for each potential Product match, namely the Product Name, Country Short Name, PMS ID, and MA Number. This improvement helps users to easily identify potential Product matches and consequently make more informed matching decisions.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-5023 - Include Country Information on Name Matching

Requirement: The Product Name matching functionality in SPORIFY has been enhanced to incorporate country information, ensuring that Products are matched to the correct country. This improvement supports international pharmaceutical companies by reducing mismatches in multi-country Product registrations, delivering more precise and region-aware results.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-5057 - Multiple Choice in Case of Multiple Match Based on MA Number

Requirement: During mapping, when multiple Target Products are identified for a Source Product based on an MA Number, the system now presents the available options to the user for selection rather than performing an automatic direct mapping. This enhancement gives users greater control and accuracy when resolving Product matches.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-5058 - New Map Type: MA Number Mapping

Requirement: Product mapping now supports the MA (Marketing Authorisation) Number as an additional map type; this means that Products can be matched based on their MA Numbers in addition to their textual names. When a match is identified through an MA Number, the match type will be displayed as 'MA Number' to provide clearer visibility into how the Product match was determined.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

Product Comparison Enhancements

SPRFY-4843 - Filtering Comparison Statuses for Re-Running Purposes

Requirement: Users can now filter comparisons by Status directly from the Source Lists screen using Preferences: Advanced Search. Multiple statuses can be selected simultaneously for filtering purposes if desired. This enhancement allows data stewards to quickly isolate failed or other specific comparison statuses, making it easier to identify and re-run comparisons in bulk without navigating to the Comparison Screen.

Impacted Areas: Compare Products, Source Products

Regression Areas: Compare Products, Source Products

Impact on Configurations: No

SPRFY-4844 - Re-Running Comparison In Bulk

Requirement: Data stewards can now re-run failed comparisons in bulk, eliminating the need to retry each one individually. When at least one comparison fails, the user is given the option to ‘Rerun failed comparisons.’ This is particularly useful when a large upload fails because it allows users to quickly reprocess all affected comparisons in a single action, significantly reducing the manual effort required during error recovery.

Impacted Areas: Compare Products, Source Products

Regression Areas: Compare Products, Source Products

Impact on Configurations: No

SPRFY-4847 - Show Comparator Error: Source Products

Requirement: Users can now view detailed error information for failed comparisons directly on the Source Products screen. When a comparison fails, the relevant IDMP section displays a "Comparison Unsuccessful" status alongside an icon that reveals a user-friendly error message on hover, thus providing the failure reason immediately and eliminating the previous 24-hour waiting period. For input-related errors, the specific reason is shown to the user, while internal errors display a unique Error Log ID that can be referenced when contacting support, enabling third-level support teams to trace the root cause.

Impacted Areas: Source Products

Regression Areas: Source Products

Impact on Configurations: No

SPRFY-4884 - Improve Comparison Performance

Requirement: The Product Comparison feature has been enhanced to deliver significantly faster results. When comparing Products, users will now experience improved response times, ensuring comparison results are returned within seconds. This performance optimisation improves the overall usability and efficiency of the comparison workflow.

Impacted Areas: Compare Products, Source Products

Regression Areas: Compare Products, Source Products

Impact on Configurations: No

SPRFY-5056 - Show Comparator Error: Compare Products

Requirement: Users can now view detailed error messages for failed Product comparisons directly on the Compare Products screen. When a comparison fails, the relevant IDMP column displays a "Comparison Unsuccessful" status alongside an icon that reveals a user-friendly error message on hover, allowing users to immediately understand the reason for the failure without waiting 24 hours. Users can also distinguish between errors that occurred before the comparison process began and those that arose during the comparison itself, enabling faster diagnosis and correction of the underlying files.

Impacted Areas: Compare Products

Regression Areas: Compare Products

Impact on Configurations: No

Miscellaneous

SPRFY-4821 - #38386 Block IS, LI & NO Country Records for Centralised Products in PMS Sync

Requirement: Centrally authorised Products associated with the authorisation countries Norway (NO), Iceland (IS), and Liechtenstein (LI) are now excluded from the Target Product List during PMS synchronisation. These Products do not require enrichment as they are neither needed by PMS downstream systems nor displayed in the PLM UI. This change eliminates count mismatches between the PLM UI and SPORIFY Target Product counts, ensuring that data stewards only see products that genuinely require mapping and enrichment.

Impacted Areas: Target Products

Regression Areas: Target Products

Impact on Configurations: No

SPRFY-5068 - #38386 Data Correction: IS, LI & NO Country Records for Centralised Products in Target List

Requirement: Centrally authorised Products associated with Iceland (IS), Liechtenstein (LI), and Norway (NO) are now excluded from the Target Product List because they do not need enrichment and are not required by PMS downstream systems. This resolves Product count mismatches between the PLM UI and SPORIFY Target Product Lists. Additionally, any existing Source-to-Target Product mappings and comparisons linked to removed Target Products will be automatically wiped by the system.

Impacted Areas: Target Products

Regression Areas: Target Products

Impact on Configurations: No

Bug Fixes

SPRFY-4787 - #38369 National Classification RMS Target List Does Not Contain Any Values

Bug Fix: A bug was resolved where several RMS referential lists, including National Classification (200000016508) and Country Subdivisions (200000032688), appeared blank after synchronisation due to the sync process failing to detect and fully re-download lists with data that had changed or terms that were not completely paginated from the EMA API. This fix ensures that all affected lists are properly identified during synchronisation and their terms are fully loaded.

Impacted Areas: Target Referentials

Regression Areas: Target Referentials

Impact on Configurations: No

SPRFY-4891 - #38356 Missing Tag in API Response for SMS and G-SRS Targets

Bug Fix: The Substance API response has been updated to include target-level tag details for SMS and G-SRS targets, resolving a previous discrepancy where tags displayed in the SPORIFY UI were missing from API outputs.

Impacted Areas: Target Substances

Regression Areas: Target Substances

Impact on Configurations: No

SPRFY-4985 - #38507 Users Cannot Log Back In From Products Tab When Their Session Times Out

Bug Fix: A bug was resolved where users were unable to log back in to SPORIFY from the Products tab when they experienced a session timeout. The token refresh mechanism and session synchronisation logic have been updated to ensure seamless background token renewal, preventing unexpected session cut-offs, internal errors, and unprompted redirects to the wrong login screen.

Impacted Areas: Cross Domain & Miscellaneous

Regression Areas: Cross Domain & Miscellaneous

Impact on Configurations: No

SPRFY-5136 - SL7 / IN - PEN - No Rate Limiting on the Forget Password & Account creation Functionality in SPORIFY Application

Bug Fix: CAPTCHA verification has been introduced on the Forgot Password and Account Creation screens in SPORIFY to prevent automated abuse. Previously, these functionalities lacked rate-limiting measures, which could allow repeated submission of requests. With this fix, users will now be required to complete a CAPTCHA challenge when resetting their password or activating their account, enhancing security against flooding attacks and automated enumeration attempts.

Impacted Areas: Security & Authentication

Regression Areas: Security & Authentication

Impact on Configurations: No

SPRFY-5203 - #38496 LOC-100023405 Detailed Page Does Not Show in the UI

Bug Fix: A bug was resolved where searching for the Location record LOC-100023405 in the Target Organisations list and clicking through to the Details Page would incorrectly redirect the user to another Location's Details Page rather than the expected record. This was linked to a prior discrepancy between the SPORIFY UI and the SPOR API, which has since been resolved by EMA (INC0175920). Following that fix, the Location became available via the API and was confirmed present in the SPORIFY database. Thus, the details page for LOC-100023405 now loads correctly.

Impacted Areas: Target Organisations

Regression Areas: Target Organisations

Impact on Configurations: No

SPRFY-5305 - #38503: Products Per MAH Should be Visible Without Integration Roles

Bug Fix: The Products per MAH chart on the Dashboard is now visible to all users with Products permissions, without requiring integration-specific roles. Previously, only administrators or users with integration roles could view this widget, preventing standard users from accessing Product overview data. This fix ensures that the permission check for the Products per MAH widget relies on the root Products permission rather than the Source Data permission, allowing all relevant users to view the Dashboard as intended.

Impacted Areas: Products Overview

Regression Areas: Products Overview

Impact on Configurations: No

Known Issues

SPRFY-4788 - [Performance] #38368 Medical Dictionary for Regulatory Activities Does Not Load (MedDRA)

Bug Fix: EMA has made this list confidential due to legal constraints. Synchronisation to SPORIFY is currently stopped. The list remains in SPORIFY while alternative sources are being investigated.

Impacted Areas: Target Referentials

Regression Areas: Target Referentials

Impact on Configurations: No

SPRFY-4858 - Sync Does Not Pick Up Items in a Previously Confidential List that EMA Made Public

Bug Fix: If EMA makes an RMS list public that was confidential earlier, the modified date does not change. Thus, the sync does not pick the list up and it will stay blank in SPORIFY. A discussion with EMA on this topic is pending.

Impacted Areas: Source Referentials, Target Referentials

Regression Areas: Source Referentials, Target Referentials

Impact on Configurations: No

SPRFY-5379 - #38517 ATC Term is Incorrect in SPORIFY

Bug Fix: EMA has made this list confidential due to legal constraints. Synchronisation to SPORIFY is currently stopped. The list remains in SPORIFY while alternative sources are being investigated.

Impacted Areas: Target Referentials

Regression Areas: Target Referentials

Impact on Configurations: No

Issues Fixed During 2026.2 UAT

SPRFY-4890 - #38418 Difference Between UI and API Request (G-SRS)

Bug Fix: A bug was resolved where the G-SRS API returned incomplete substance data. Previously, when retrieving substance details via the G-SRS API, only a single official substance name was returned instead of all associated names that were visible in the UI. This was caused by the G-SRS sync using an incorrect URL parameter, which has now been corrected to return the full substance model, ensuring API responses include all official substance names linked to a given UNII.

Impacted Areas: Target Substances

Regression Areas: Target Substances

Impact on Configurations: No