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...
Revision IML Code of Ethics

Revision IML Code of Ethics

Luxembourg As previously announced, IML, the association of the innovative pharmaceutical industry in Luxembourg has revised and updated their Code of Ethics. The proposed amendments have been approved at the General Assembly held on 17 April 2023. The amounts of...
Update instructions for distribution of DHPC in Luxembourg

Update instructions for distribution of DHPC in Luxembourg

Luxembourg Division de la Pharmacie et des Médicaments de la Direction de la Santé has published updated instructions for the distribution of DHPC in Luxembourg (version 2.0 – 02/2023). A significant change in the updated version is the addition of the paragraph...
Update instructions for distribution of DHPC in Luxembourg

Update Procedure for MA applications in Luxembourg

Luxembourg 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...