Instructions for MAHs for the submission of aRMM and DHPC in Luxembourg

Luxembourg

The Luxembourg national competent authority Division de la Pharmacie et des Médicaments de la Direction de la Santé has published 2 new documents.

1. Instructions for marketing authorization holders for preparation and submission of additional risk minimization material (aRMM) for evaluation and approval in Luxembourg
2. Instructions for marketing authorization holders for distribution of direct healthcare professional communication (DHCP) in Luxembourg

Source: https://sante.public.lu/fr/politique-sante/ministere-sante/direction-sante/div-pharmacie-medicaments/index.html