The use of the PLM Portal web-based electronic application form for human variations is now recommended and an eCTD validation report for Belgium as Reference Member State (RMS) is required.
The PLM Portal web-based electronic Application Form (eAF) is now recommended for submitting variation applications for non-centrally authorised products (non-CAPs). This recommendation is part of the gradual transition toward making the PLM Portal web-based eAF the mandatory method for all human variation applications. This applies to products authorised through the Decentralised Procedure (DCP) or Mutual Recognition Procedure (MRP) and National procedures (NAP), but not centrally authorised products (CAPs).
You can still use the interactive PDF version of the eAF for now, especially in cases where the web-based form does not yet support certain features or has technical limitations. Make sure to check the official guidance documents and release notes for details.
If you experience any technical problems, report them via the EMA ServiceDesk – Incident.
For questions, suggestions, or requests for improvements, use the EMA ServiceDesk – Request option.
In order to make use of these two services from the EMA ServiceDesk, you will need to have an EMA username.
Levels of Web-Based eAF Usage
• Optional Use: You can choose either the web-based or PDF form.
• Recommended Use (current stage): The web-based form is encouraged, but you can still use the PDF form if needed.
• Strongly Recommended Use: Use the web-based form in most cases. Use the PDF only if absolutely necessary.
• Mandatory Use (future stage): Only the web-based form will be accepted. PDF submissions will be rejected after an official transition period.
eCTD Validation Report Requirement – Belgium as RMS
If you are submitting a dossier via the DCP or MRP and Belgium is the RMS, you must include a valid eCTD validation report in your submission. Check the EU Module 1 validation criteria on the EMA website for more details.