Posted Mon, 17 Apr 2023 14:52:59 GMT by Kristiina Puusaari

We are pleased to inform you the updated PLM (Product Lifecycle Management) Portal web-based electronic Application Form (eAF) for Human medicinal products release timeline is available at the following link.

Note in particular the following periods: 

June 2023  

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.