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...
Medical devices – turnover declaration

Medical devices – turnover declaration

Belgium As from the start of 2023, a new system for funding market surveillance of medical devices by FAMHP applies. Unlike before, this will no longer be limited to the sale of medical devices to retailers and end users.  All actors that carry out an activity...