New CMDv Guidance on the Submission of G.I.18 Variations

12 June 2024

CMDv has published guidance on the submission of G.I.18 variations requiring assessment. The Danish Medicines Agency requests that all Marketing Authorisation Holders (MAHs) carefully review the principles in this document to ensure the process of submitting and obtaining approval of a G.I.18 variation is as efficient and smooth as possible.

According to Article 152 of Regulation (EU) 2019/6, MAHs must update the product information for existing products by 29 January 2027. Updating the product information in line with version 9 of the QRD template must be done by submitting a variation requiring assessment, under the classification G.I.18.

The CMDv guidance outlines the procedural aspects and principles to be followed to achieve an efficient and smooth process when submitting the required variations:

  • Limited scope of the variation: G.I.18 variations should focus on aligning the product information with QRD version 9 and must not include additional changes or alignment with scientific guidelines.
  • Grouped variations and worksharing: Applications for implementing QRD version 9 through grouped variations and worksharing should be avoided to minimise delays.
  • Standard timetable with shortened clock-stops: The variations will follow a standard 90-day timetable with shortened clock-stops.
  • Use of a simplified assessment report: The RMS may choose to use a simplified assessment report.
  • RMS responsibility: The RMS has primary responsibility for the assessment, with CMSs only commenting in exceptional cases.
  • National requirements: National labelling requirements are handled separately during the national phase.

The CMDv guidance also includes a checklist for MAHs to help achieve "Right First Time" submissions.

For further information and access to the guidance, please refer to the CMDv website.