by In2Pharma | Mar 6, 2026 | News
Luxembourg From 1 January 2026, nicotine pouches and other novel nicotine-containing products will fall under the same regulatory framework as traditional tobacco products. The new rules introduce a ban on advertising, prohibit the free distribution of these...
by In2Pharma | Jan 5, 2026 | News
Luxembourg The LU agency (DPM) has updated its internal guidance document outlining all steps related to market authorization procedures in Luxembourg. Key Amendments: Decentralised, Mutual Recognition, and Repeat Use Procedures (MRP/DCP/RUP) Variations Type IA / Type...
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...
