On 20 January 2023, the Luxembourg authorities updated their document ‘Procedure for marketing authorisation applications in Luxembourg’, version 3.
A new tab was created in the excel file with information regarding the Product information.
The DPM of Luxembourg informs MAH that they 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, respectively) of medicinal products distributed from Belgium and intended for Luxembourg market.
It is a new requirement that the LU authorisation numbers need to be included in the BELU product information.
The FAMHP and the DPM accept that the change of the product information can be carried out via an editorial change, at the time of a next submitted variation with impact on the product information. 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) and in the cover letter;
– The implementation period is one year from 21 January 2023; this change can also be submitted separately as a variation of type IA C.I.Z.
After the one-year implementation period, these changes will be considered as IA C.I.Z. variations.