The Federal Agency for Medicines and Health Products (FAMHP) will send out invoices for most of its services from now on. Consequently, companies will no longer need to make advance payments when submitting files.
The FAMHP is working closely with the affected parties to find a solution for clinical trials which may encounter problems after Brexit.
The FAMHP points out to marketing authorisation (MA) holders and applicants the rules for harmonisation of SPC’s, labelling and patient information leaflets (PIL) in different countries. MA holders and applicants can find all new rules on the FAMHP website.
A new law states that full line wholesalers can only provision the Belgian marker, in the framework of their public service services. Medicines intended for the Belgian market can only be supplied to Belgian pharmacies or other wholesaler-distributors. Implementation decrees will supplement the law. For example, medicines that cannot be delivered for three days in a row are considered unavailable. The obligation to deliver from pharmaceutical companies to full line wholesalers will also be set on three working days.
Every company selling implants and certain invasive medical devices in Belgium must report the data for these in a notification database. The notification of these medical devices applies as a condition for reimbursement of the obligatory insurance for health care. From June 3, 2019 the notification of these medical devices in the database will occur via a new online application at the Federal Agency for Medicines and Health Products (FAMHP).
The European Medicines Agency (EMA) recommends not to start new treatments with LEMTRADA®. Treatment of new patients with LEMTRADA® (alemtuzumab) can only be initiated in adult patients with highly active relapsing-remitting multiple sclerosis (RRMS), despite complete and adequate treatment with at least two other disease-modifying therapies (DMT), or in adult patients with highly active RRMS for whom any other DMT is contraindicated or unsuitable.
Through possible limited availability of intravenous immunoglobulins, there is a threat of a shortage in some hospitals in Belgium. The Federal Agency for Medicines and Health Products (FAMHP) is giving recommendations for hospital pharmacists and physician-specialists within the hospitals.
When the United Kingdom (UK) leaves the European Union (EU) this will have consequences for the trade in drug precursors. Different scenarios are possible.