Flat Fee 2025

Flat Fee 2025

Luxembourg The yearly annual Flat Fee that will be applicable for the FMD operational phase in 2025 in Luxembourg has been fixed. The fee is needed to cover the costs related to the system, participation of LMVO in the costs of the EU Hub… The defined thresholds are:...
Update of the IML code of ethics

Update of the IML code of ethics

Luxembourg The IML Code outlines the ethical standards that its members have committed to follow when promoting medicines to healthcare professionals (HCPs) and engaging with HCPs, healthcare organizations (HCOs), and patient organizations (POs). These guidelines...
Update Adverse drug reaction reporting details

Update Adverse drug reaction reporting details

Luxembourg On January 17th, EMA published the newest version (v28) of QRD Appendix V. In this version, the contact details for reporting adverse drug reactions in Luxemburg has been changed, to include the German version of the address. Luxembourg/Luxemburg [French]...
Publication guideline on BE/LU packages

Publication guideline on BE/LU packages

Belgium/Luxembourg On Thursday 1st of June, the Luxembourg authority DPM published the “Guideline on BE/LU packages”. This guideline assists applicants/MAH in creating or updating a common BE/LU pack and Product information (PI) for medicinal products for...