Maintenance of Gateway XML FileHandler and PSUR Repository
eSubmission services including Gateway XML FileHandler and PSUR Repository will undergo scheduled maintenance on 7 January 2026.
Marta Marcelino INFARMEDParque de…
Marta Marcelino INFARMEDParque de Saúde de LisboaAvenida do Brasil, n° 53PT-1700 LISBOA
Nebivolol hydrochloride /…
Nebivolol hydrochloride / amlodipine besilateDate of publication: 17/12/2025
RifabutinEnd of procedure:…
RifabutinEnd of procedure: 20/08/2025Date of publication: 17/12/2025
Levothyroxine / LiothyronineEnd of…
Levothyroxine / LiothyronineEnd of procedure: 30/07/2025Date of publication: 17/12/2025
Reminder of Cut-Off Date for New Variation Classification
Applications using the new variation classification forms must not be submitted before 15 January 2026, otherwise they will be rejected and require resubmission.
EMA Q&A Session on New Variation Classification
EMA will host a dedicated Q&A clinic on 8 January 2026 to answer questions regarding eAF functionality changes related to the revised variation classification guideline.
Reminder to Include FHIR XML with PLM Portal eAF Submissions
Applicants are reminded that all PLM Portal-generated eAFs must include the corresponding FHIR XML attachment when submitted to health authorities.
Optional Use of eCTD v4.0 for CAP New MAAs Goes Live
From 22 December 2025, applicants may optionally submit new CAP Marketing Authorisation Applications using eCTD v4.0 while eCTD v3.2.2 remains accepted.
PLM Portal eAF Version 1.2.1.2 Release Notes Published
Release notes for version 1.2.1.2 describe bug fixes and updates implemented in the December 2025 production release.