Following the launch of the web-based Human Variation electronic Application Form (eAF) for Centrally Authorised Products (CAPs) on the PLM Portal, users have accessed the PLM Portal to work on variation applications using the new web-form. This is a valuable step for users to familiarise themselves with the system as well as for the development team to gain more insights on features to improve and issues to fix.
The development team’s priority now is addressing issues in the web form and stabilising it. Following this, work will continue adding the data and functionalities needed to fully support national, MRP and DCP variations application procedures and submissions.
EMA has therefore decided that the previously planned industry external User Acceptance Test (UAT) in January 2023 will be rescheduled to a date expected to be announced in the first half of 2023. The UAT will be scheduled when there are meaningful new features and capabilities to be tested.
To support stakeholders’ planning for possible participation in the UAT and anticipate eventual transition to the use of the web-forms please note the following:
• The target window for introducing Nationally Authorised Medicinal Products (all NAPs, including MRP/DCP) to the variation application form is now Q2 2023;
• In addition, further capabilities need to be introduced to make the variations eAF ready to start a formal transition period, the target window for release of these features is Q2-Q3 2023
• More precise time windows will be shared in the first half of 2023 with the aim of providing a minimum of a 2-month lead time before the UAT or a major release
