Information for marketing authorisation holders

Information regarding the pharmacovigilance system for holders of marketing authorisations for medicinal products for human use

1. Local Person for Pharmacovigilance (LPPV)
   
   As part of the pharmacovigilance system, the marketing authorisation holder (MAH) must have an appropriately qualified person responsible for pharmacovigilance who is permanently and continuously available. The LPPV must reside and work in the European Union. The MAH must communicate to the Health Directorate the name and contact details of the qualified person, as well as the reference person for pharmacovigilance at national level attached to the LPPV.
   
   Declaration form (Word, 243 Kb) for notification of the contact person for pharmacovigilance at national level (or local person for pharmacovigilance/LPPV))
   
   
2. Additional risk minimisation measures (aRMM)
   
   Instructions (pdf, 539 Kb) (Pdf, 203 Kb) for the preparation and submission of additional risk minimisation material (aRMM) for evaluation and approval in Luxembourg
   
   
3. Direct communications for healthcare professionals
   
   Instructions (pdf, 205 Kb) (Pdf, 192 Kb) for distribution of Direct Healthcare Professional Communications (DHPC) in Luxembourg
   
   DHPC logo and abbreviation for download below.