Update FAQ additives and additives legislation

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

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

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...
Amendment RD Plants

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

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...