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...
by In2Pharma | Nov 4, 2024 | News
Luxembourg The yearly annual Flat Fee that will be applicable for the FMD operational phase in 2025 in Luxembourg has been fixed. The fee is needed to cover the costs related to the system, participation of LMVO in the costs of the EU Hub… The defined thresholds are:...
by In2Pharma | Aug 26, 2024 | News
Luxembourg The IML Code outlines the ethical standards that its members have committed to follow when promoting medicines to healthcare professionals (HCPs) and engaging with HCPs, healthcare organizations (HCOs), and patient organizations (POs). These guidelines...
