Posted Fri, 15 Mar 2024 13:41:30 GMT by Kristiina Puusaari

electronic Application Forms (eAFs) not available for use between 11th and 16th April 2024 due to planned maintenance (15-03-2024)


Due to planned maintenance activities, the interactive pdf eAFs (human and veterinary variation and MAA forms and the renewal form) and the PLM Portal web-based eAF will be unavailable for use between 11th and 16th April 2024.

Additionally, as announced in December 2023, the PLM Portal web-based eAF will be affected by the data load of Centrally Authorised  Products (CAPs) and Nationally Authorised Products (NAPs) into Product Management Service (PMS) as well as the simultaneous load of updated* CAPs to web-based eAF.
This load of data into PMS is a necessary step in preparation to the forthcoming launch of the Product User Interface view and later edit functions as well as making NAPs data available for the PLM Portal web-based eAF.

The data load will take place from 11 to 16 April 2024. During this timeframe, the interactive PDF eAF and the PLM Portal web-based eAF will experience a downtime.
Please note that, during the preparation for the updated* CAPs load in the PLM Portal web-based eAF, the match-merge** operation will result in:

  • changes to product names;
  • introduction of new medicinal products through splitting**;
  • potential alterations to packages.

These changes will impact how products appear in application forms. Therefore, we strongly recommend, with immediate effect, that no applications that might require any update of the eAF, during or after the product upload, are submitted to EMA using the PLM Portal web-based eAF.  We strongly recommend to use the interactive pdf eAF instead of the web-based eAF for submissions at least until 26 April 2024 to prevent validation issues and potential delays.
Please note that if you have already submitted a web-based eAF, or it is expected that there will be no need to update the form and/or the procedure will conclude prior to the downtime, you can continue using the web-based eAF.

Please note that, except for the downtime period, the web-based eAF is expected to remain accessible to applicants to familiarise themselves with changes to the products, and for training purposes.

*Including split & match-merge processes. Please refer to EU IG (Implementation Guide) Chapter 7 for a detailed description of these steps.
**The “Match-merge” process serves to include data from XEVMPD to products already released in PLM Portal. The “split” process serves to make released products ISO-IDMP compliant. Both processes are explained in detail in EU IG Chapter 7