In future, submissions of #variation notifications for #medicinalproducts for human use are to be made exclusively via the electronic application forms (#eAFs).
The timelines for the full implementation of these systems have now been updated again and are listed on the #EMA website in the #PLMPortal (Product Lifecycle Management Portal).
Note in particular the following periods:
June 2023
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Start of data transfer – Centrally Authorised Products (CAPs) and Nationally Authorised Products (NAPs) for use in eAFs – the first NAPs products will appear in the eAF. This will allow users to start preparing web-based eAFs for NAPs as these products become gradually available on the PLM Portal; |
August 2023 | Expected completion of data transfer – all CAPs and NAPs available in eAF; |
November 2023 | User Acceptance Testing (UAT) on the version of the web-based eAF intended to replace the PDF and trigger the transition; |
Q1 2024 | Confirmation of transition period start date, approximately 2 months in advance. This is subject to a successful outcome of the UAT; |
Q2 2024 | Start of 6-months transition to mandatory use of web-based eAF for Human Variations. This is subject to a successful outcome of the UAT. Note that the transition period may start earlier, if feasible, respecting the 2- month advance notice period. |
A second version of this updated timeline (2nd page of the document) also shows in detail the impacts for eAF users in the different periods, as supplementary information.
Please note:
- Functionalities required for mandatory use are being released incrementally: all required functionalities will be available on the PLM Portal before the start of the UAT.
- The use of the web-based eAF will follow the current process for updating data. Use of structured data will be implemented at a later point.
- The capability to view migrated PMS product data in the Product User Interface on the PLM Portal is under development in parallel – delivery timelines will be announced at a later date.
- Details on how the UAT will be organised will be shared in due course.