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)
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...
Publication guideline on BE/LU packages

Publication guideline on BE/LU packages

Belgium/Luxembourg On Thursday 1st of June, the Luxembourg authority DPM published the “Guideline on BE/LU packages”. This guideline assists applicants/MAH in creating or updating a common BE/LU pack and Product information (PI) for medicinal products for...
New fees for food supplement notifications

New fees for food supplement notifications

Belgium Due to the publication of the Royal decree about fees for raw materials and products (RD of 13 novembre 2011), the amount of the fees for notifications of food supplements has been modified. From May 21st 2023, the fee for a food supplement notification will...