Recommended use of web-based human variations eAF for all CAP variations
In a further step towards progressively increasing the use of the PLM Portal web-based eAF for all CAPs variations, EMA now strongly recommends applicants use it for these applications in anticipation of eventual required use. Additionally, EMA is planning to extend the use of the PLM Portal web-based eAF for non-CAP procedures concerning variations for human medicines.
date: 12/07/2024
Following optional use over the past two years, EMA now strongly recommends the use of the PLM Portal web-based eAF for all CAPs variations. Initially communicated in May, encouraging steady growth of this form supports applicants familiarity and preparedness for eventual mandatory use. It also provides EMA with insights to further improve the system. Currently there are still some limitations that EMA is actively addressing. Note that these do not prevent the use of the web-based eAF in the majority of the cases.
To continue the vision of enabling the use of the web-based eAF for all variations in the EU for human medicines, EMA is further expanding and executing a performance improvement strategy during the coming months, as well as addressing relevant user feedback.
Following the planned PMS NAPs go-live in September 2024, and subject to the implementation of the successful performance approach, EMA plans to extend the use of the PLM Portal web-based eAF for non-CAP procedures concerning variations for human medicines.
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