by In2Pharma | Oct 17, 2025 | News
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...
by In2Pharma | Oct 13, 2025 | News
Luxembourg A new version (V5 – September 2025) of the document ‘Fees in relation to marketing authorizations Luxembourg’ has been published. This updated version clarifies that for applications for variation type IA/IB, no fees are required for notifications (e.g.,...
by In2Pharma | Jun 3, 2025 | News
Luxembourg As part of our ongoing regulatory intelligence monitoring, we identified a key update on the santesecu.public.lu website: the first edition of the Pharmacovigilance (PV) Bulletin was published by Santé publique Luxembourg on 26 March 2025. This bulletin was...
by In2Pharma | Apr 11, 2025 | News
Luxembourg All Marketing Authorization Holders (MAHs) should have received a communication from the Luxembourg authorities regarding discrepancies in Marketing Authorization (MA) numbers for MRP/DCP and national procedure products in XEVMPD. This is part of an ongoing...
by In2Pharma | Feb 14, 2025 | News
Luxembourg Since January 2025, the payment system for variation fees in Luxembourg has changed. In the past, variation fees were paid bi-annual and based on the number of products and variations included in the submission. As from January 2025, variations need to be...
