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Update FAQ additives and additives legislation
Belgium On 5 February 2024, the Belgian authority has published an update of the FAQ on additives. The FAQ was extended from 27 to 41 pages with the addition of 20 new questions. Source: FAQ additieven | FOD Volksgezondheid (belgium.be)
Circular 654 – Inspection on Full FMD Implementation
Belgium As previously announced, since 9th of Feb 2024, Belgium and Luxembourg switched to a full EU-FMD implementation. The Belgian NCA (FAGG / AFMPS / FAMHP) now published Circular 654 for the attention of the inspectors involved in the control of the distribution...
Update Adverse Drug Reaction reporting details
Belgium On February 29th, EMA published the newest version (v29) of QRD Appendix V. In this version, the contact details for reporting adverse drug reactions in Belgium has been changed, since the authority has decided to abandon the use of a postal address and go...
FASFC renews digital identity
Belgium The Federal Agency for the Safety of the Food Chain (FASFC) has been revamping its digital identity on its 25th anniversary with a new logo and home style. Despite the new visual identity, the core message remains the same: ensuring that all actors in the food...
Amendment RD Plants
Belgium An amendment of the Belgian Royal Decree regarding the manufacture and trade of foodstuffs composed of, or containing, plants or plant preparations (RD August 31, 2021) has been published on 30 January 2024. The RD has come into force on 9 February 2024...
NIHDI posts new FAQ on tenders for biologicals
Belgium Hospitals must, according to the Royal Decree of 13 September 2023, issue a tender for biological and biosimilar medicines within nine months after a first biosimilar pharmaceutical speciality, authorized in accordance with the law of March 25, 1964 on...
Data basic training Keuringsraad
The Netherlands Koag Kag/Keuringsraad has published the data for their basic training on the codes for promotion towards general public regarding medicinal products, medical devices and health products. This training takes place in Breukelen, The Netherlands, at...
Update Adverse drug reaction reporting details
Luxembourg On January 17th, EMA published the newest version (v28) of QRD Appendix V. In this version, the contact details for reporting adverse drug reactions in Luxemburg has been changed, to include the German version of the address. Luxembourg/Luxemburg [French]...
Planning tool for requesting timeslots expanded to more procedures
The Netherlands Via the MEB website, a planning tool is already available to reserve a timeslot for requesting assessment procedures for decentralized procedures. The planning tool helps the MEB to properly plan the required capacity. This tool has now been expanded...
Publication Royal Decree on Nutrivigilance
Belgium Since 03 December 2023, a new royal decree has been published regarding the reporting of adverse reactions related to the use of food supplements. This Royal Decree defines the legal framework for Nutrivigilance, but not its mode of operation in...
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