How can health authorities such as the Federal Agency for Medicines and Health Products (FAMHP), in cooperation with the FPS Public Health, Safety of the Food Chain and Environment (SPF Public Health), the National Institute for Illness and Invalidity Insurance (RIZIV) and the Federal Knowledge Centre for Health Care (KCE) involve patients more (pro)actively and put them in a more central position throughout the complete development cycle of innovative medications?
From January 2020 there is a new nomenclature applicable for manufacturers reporting an incident with a medical product to the FAMHP. The FAMHP advises manufacturers of medical devices to already change their internal codes to the new nomenclature codes.
The pharmacist can now only deliver medications up to three months after the prescription date, with the exception of when the prescriber indicates a date of delivery. For reimbursed medications, the reimbursement date is also three months from the date on which the prescriber issued the prescription.
Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The results of these risk assessments can now be reported.
Via the new online application PharmaStatus, marketing authorization holders can notify the FAMHP of unavailability and start or stop of commercialization of a drug. Marketing authorization holders are invited to an information session on November 18, 2019.
The Federal Agency for Medicines and Health Products (FAMHP) is holding a symposium on vaccines on Friday 6 December 2019. The symposium will highlight certain current challenges in the development of new vaccines and the improvement of existing vaccines. Spekers will also talk about the role of various Belgian public institutions in bringing vaccines to market and monitoring them.