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.
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Register now for the FAMHP symposium “Cooperating with and for the patient”
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?
11 and 17 December 2019: final date for submitting dossiers during Christmas holidays
During the Christmas holidays, the FAMHP will be closed from Wednesday 25 December 2019 until Wednesday 1 January 2020 included.
As of November 1, 2019, the duration of validity of a medical prescription will be a standard three months
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.
New ESVAC report: antibiotics use falls again in animal breeding in Europe. Further efforts are necessary, in Belgium as well
The European Medicines Agency (EMA) published the ninth ESVAC report (European Surveillance of Veterinary Antimicrobial Consumption) about the sale of antibacterial agents for veterinary use in 2017.
Update - Unavailability and start or stop of commercialisation: no reporting possible between December 2 and 5, 2019
A new reporting system will be available on December 5, 2019. To avoid errors, reports may only be made through the current system until December 2, 2019.
New request form for validation of DHPCs
From 1 November 2019, a new form will apply for requesting validation of Direct Healthcare Professional Communications (DHPCs).
Information session about PharmaStatus, the new application for reporting and consulting unavailability and start or stops of commercialisation
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.
Save the Date: Register for the Vaccine Symposium on 6 December 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.
Save the date: “Working together with and for the patient” symposium
How can public health authorities such as the FAMHP, in cooperation with the FPS Public Health, the RIZIV-INAMI and the KCE, involve the patient more proactively and make the patient more central through the entire development cycle of innovative drugs? Come and find out everything at the third symposium of the FAMHP, where patients are central, on Tuesday, December 10.