Logistic change APB Recalls

Logistic change APB Recalls

Belgium Since May 2nd, 2024, APB has changed to CSP-Movianto as partner for handling their logistics related to recalls. This move allows them to streamline operations while maintaining quality and efficiency. Additionally, APB has a new RP (Responsible Person). Due...
Dates GMH trainings 2024

Dates GMH trainings 2024

The Netherlands GMH organizes multiple trainings on the regulation of premiums and benefits with regard to medical devices. They offer two levels of training: a basic training and a more advanced training. These trainings will take up one half of a day (before noon)...
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...