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:
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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;
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August 2023
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Expected completion of data transfer – all CAPs and NAPs available in eAF;
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November 2023
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User Acceptance Testing (UAT) on the version of the web-based eAF intended to replace the PDF and trigger the transition;
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Q1 2024
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Confirmation of transition period start date, approximately 2 months in advance. This is subject to a successful outcome of the UAT;
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Q2 2024
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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.
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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:
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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.
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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.
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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.
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Details on how the UAT will be organised will be shared in due course.
