Luxembourg
As part of the pharmacovigilance system, the marketing authorization holder has at its disposal, on a permanent and continuous basis, an appropriately qualified person responsible for pharmacovigilance. The person responsible for pharmacovigilance resides and operates within the European Union. The marketing authorization holder shall notify the Health Directorate of the name and contact details of the qualified person, as well as the national pharmacovigilance contact person (LCPV) reporting to the qualified person responsible for pharmacovigilance activities in Luxembourg.
Since May 2025, a revised version (V2) of the Luxembourg nomination form has been published.
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