by In2Pharma | Oct 27, 2023 | News
Belgium On 16 October, the Belgian federal agency for medicines and health products (FAMHP) has introduced a new application for the effective management of marketing authorisation and vigilance dossiers. Data Tracking System (DTS) will replace 4 MeSeA applications:...
by In2Pharma | Sep 29, 2023 | News
Belgium The Belgian “National Medicines Verification System” (NMVS) is linked to the “European Alert Management System” (EAMS) via a “National Alert Management System” (NAMS) since 1 July 2023. Since there is now the possibility of...
by In2Pharma | Aug 4, 2023 | News
Belgium The FAMHP will open a new web portal later this year for manufacturers based in Belgium who are subject to inspections in the context of a GMP certificate, manufacturing and import authorization (MIA), raw materials (AR 97), active ingredients (API) or...
by In2Pharma | Aug 3, 2023 | News
Belgium The Belgian government has issued a royal decree (19 January 2023) allowing the export of medicines to be temporarily restricted. The decree allows an export in case of unavailability to be subject to prior authorisation, if it concerns essential medicines and...
by In2Pharma | Jun 28, 2023 | News
Belgium The FAMHP again confirms and clarifies their interpretation of the rules set out in Annex 21 in the light of fiscal importation of medicines: “Fiscal importation” means the purchase/procurement ‘on paper’ of medicines that have not left the...
