As anticipated in October 2023, the electronic Application Form (eAF) and Product Management Service (PMS) teams would like to provide you with
an update on the progress of the web-based Human variations eAF implementation on the
Product Lifecycle Management (PLM) Portal
During
Q4 2023, we completed the load and evaluation of PMS data in PMS User Acceptance Testing (UAT) environment, after which we proceeded to testing of PMS data in the PLM Portal. While performing these activities, we observed the following:
- Bugs in PMS related to match-merge* of Centrally Authorised Products (CAPs);
- Technical issues with the eAF preventing testing;
- System performance improvements required for the PLM Portal.
Taking into consideration these findings, we have made the necessary
adjustments to planning. Kindly find
here a visual representation of the updated plan.
Please note that Alpha UAT for Product User Interface (UI) data quality is still ongoing and proved successful thus far, as no blocking bugs have been identified.
Key points of the updated plan:
Q1 2024:
- Deployment in production of new eAF features (e.g., clone application, add package, rename application) developed in Q4 2023.
- Consolidation of all PLM portal products' development (eAF, Product UI, ePI) under a single service provider.
Q2 2024:
- Release of all CAPs & NAPs in the PMS database. Simultaneously, release of updated** CAPs in eAF;
- Delivery of PMS Application Programming Interface (API) - with CAPs and Nationally Authorised Products (NAPs) available in view-only mode - and Product UI - with CAPs available in view-only mode and NAPs not yet viewable.
Please note that, during the
preparation for the updated** CAPs load in eAF in Q2 2024, the match-merge* operation will result in:
- changes to product names;
- introduction of new medicinal products through splitting*;
- potential alterations to packages;
This will impact how products appear in application forms. Therefore, we will communicate in due course the 3-week period where it is advisable to use the interactive eAF (PDF) instead of the web-based eAF for submissions to prevent validation issues and potential delays.
Please note the web-based eAF will remain accessible to applicants to familiarise themselves with it and for training purposes.
Q3 2024:
- Performance improvements and internal testing
Q4 2024:
- Release of NAPs in the eAF
The updated planning does not foresee in 2024:
- external testing of the eAF UAT
- consequently, no transition start towards mandatory use of the Human variations web-based eAF. However, we would recommend the use of the web-based eAF for CAPs submissions following the updated** CAPs release.
Please send any questions to
eSubProgofficer@ema.europa.eu or post them via the
PLM Portal Forum.
*The “Match-merge” process serves to include data from XEVMPD to products already released in PLM Portal. The “split” process serves to make released products ISO-IDMP compliant. Both processes are explained in detail in
EU IG Chapter 7
**Including split & match-merge processes. Please refer to
EU IG Chapter 7 for a detailed description of these steps.
