Last updated: 21 October 2026
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Marketing authorisation application and Variation electronic application forms (eAF) for centrally authorised products – naming convention reminder
Applicants and Marketing Authorisation Holders (MAHs) are reminded that the prescribed naming convention for electronic application forms (eAFs) must be followed. Compliance with this convention enables the correct identification of eAF files within submission sequences received by EMA and supports their automated processing.
For human medicinal products, the applicable naming convention for marketing authorisation applications (MAAs) and Variations is described in:
- eCTD 3.2.2 – EU Module 1 Implementation Guide (v3.1.1, page 34); and
- The corresponding validation criteria, specifically the worksheet “File-folder structure and names.”
EMA’s internal systems (IRIS) identify the eAF through an automated search for the string “ema-form-eaf”. If the naming convention is not followed, the system may be unable to correctly identify the eAF, which could affect processing.
As part of the validation process, submissions will be checked for compliance with this requirement. Where the naming convention has not been respected, applicants may be requested to resubmit the package with the correct filename.
Applicants are therefore strongly encouraged to verify the eAF filename before submission to avoid validation issues and potential processing delays.
Source: eSubmission
European Medicines Agency post-authorisation procedural advice for users of the centralised procedure
Here, you can view the track changed (13 July 2026) and clean versions (5 October 2026) of the document with the above title. Responses to the following questions have been updated:
- 1.1. When shall I submit my Type IA/IAIN variation(s)?
- 3.8. How shall I present my application for a new or modified therapeutic indication?
- 3.11. How shall my Type II application be handled (timetable)?
- 3.13. Which post-opinion steps apply to my Type II variation and when can I implement the approved changes?
- 3.25. When will I get a PIP compliance statement?
- 4.12. How shall my Extension Application be handled (timetable)?
- 17.30. How shall I implement the outcome of a PSUSA procedure?
- 17.35. What fee should I pay and whom to contact if I have an issue related to the payment of fee and QPPV advice notes?
- 22.1. What is an Article 61(3) Notification?
- 22.3. When can I submit my 61(3) Notification?
Source: EMA
European Medicines Agency pre-authorisation procedural advice for users of the centralised procedure
Here, you can view the track changed (18 August 2026) and clean versions (5 October 2026) of the document with the above title. Responses to the following questions have been updated:
- 6.1.6. What are the protection periods for orphan medicinal products?
- 6.2.1. Extension of the ten-year period of marketing protection in the case of new therapeutic indications (8 + 2 +1)
Source: EMA