MAHs will have to indicate the MA number(s) and/or the paragraph on the reporting of adverse reactions on the product information (SmPC, labelling and PIL,) of medicinal products distributed from Belgium and intended for the Luxembourg market.

This information needs to be added via a variation.

The FAMHP and the DPM accept that the change is  submitted via an editorial change simultaneously with another variation with impact on the production information. This variation must be submitted between 21 January 2023 and 31 December 2024. However, the following conditions must be met:

  • The change must be clearly indicated in the application form of the variation (scope and ‘present and proposed’ part) and in the cover letter;
  • Submission via eCTD is requested except in case of MRP/DCP national phase since only the translations are concerned.
  • If re-assessment of the mock-up, due to readability issues, becomes necessary, these changes can only be accepted in the scope of variations with impact on the labelling/mock-up.

This change does not impact centrally authorised medicines.

What are the applicable timelines?

The timelines for this change have been extended and are now as follows:

A diagram of a timeline

Description automatically generated with medium confidence

  • Deadline for submission as an editorial change: 31/12/2024
  • After this timeline, the changes will be considered IA C I Z variations
  • Deadline for implementation – all new batches with LU information : 30/06/2025
  • The period of 6 months for implementation after approval still applies in both countries.

Are you ready?

The Luxembourg authorities have published a guidance on shared Belgium-Luxembourg packaging, which can assist MAHs on the submission of these variations. The guidance can be accessed at the following link.

Do not hesitate to contact us if you need further information or support with the practicalities of these submissions.