On 29 September 2025, the European Medicines Agency (EMA) announced that it strongly recommends the use of the PLM Portal web-based electronic Application Form (eAF) for all non-CAPs* human variations, where possible.
PLM Portal web-based eAF – Levels of use:
Optional Use: Both the interactive PDF and the web-based eAF are available. Applicants may choose either format, and no preference is expressed.
Recommended Use: The use of the web-based eAF is encouraged. However, PDF is still accepted.
Strongly Recommended Use (current stage): The web-based eAF should be used in most cases. The interactive PDF should only be used as a fallback in case of technical issues or missing features.
Mandatory Use: The use of the web-based eAF is required. It will only be introduced after a formally announced transition period.
*Products authorised throughout mutual recognition procedure (MRP), decentralised procedure (DCP) and national procedure (NAP).
Note that while the PLM Portal eAF is now strongly recommended for use for all procedure types, there are some technical limitations. For these cases, you might need to consult the guidance.
Need guidance on making the switch? Reach out to our team at [email protected]
