The FAMHP online medicinal products database contains information on all medicinal products for human and veterinary use authorised in Belgium. Some new functions have been added in this new version. This makes it easier to search for new medicinal products or active ingredients.
The availability of appropriate antimicrobial medicines is important to fight antimicrobial resistance. The FAMHP strives to keep or to bring essential antimicrobial products on the market and to keep healthcare professionals and patients well informed. Again, as a result of those efforts: amoxicillin for injection/infusion has been back on the market in Belgium since April.
2021 was the year we gradually returned to our normal way of working at the FAMHP. The high workload caused by the pandemic remained present, but numerous other important projects awaited us, such as the implementation of several European legislations. In addition to the traditional facts and figures, the 2021 annual report includes testimonials that demonstrate the commitment and professionalism of our staff.
On 4th of July 2022, the FAMHP launches the Medicinal Product Management database, a new internal database for medicinal products. Due to the launch, it will be temporarily impossible to update the data in the existing medicinal product databases.
During its June 2022 meeting, the Pharmacovigilance Risk Assessment Committee (PRAC) of the European Medicines Agency (EMA) is continuing its assessment of cases of heavy menstrual bleeding (heavy periods) with the COVID-19 mRNA vaccines and the PRAC finds no link between mRNA COVID-19 vaccines and absence of menstruation. The PRAC also discussed a direct healthcare professional communication (DHPC) containing important safety information for Xalkori.
The Vigilance Division of the FAMHP requests marketing authorisation holders to send the approved version of the risk management plan for medicinal products for human use with a national marketing authorisation.
Extensive analyses of Philips' CPAP, BiPAP and ventilator devices have not revealed toxicologically relevant levels of volatile organic compounds. Nevertheless, no risk can be excluded at this time: patients are advised to consult their physician about the further course of their treatment.
Due to the ending of the epidemiological emergency situation on 10 March 2022, the Belgian guideline to assist sponsors in the management of clinical trials during the coronavirus pandemic no longer applies. From now on, the rules in force will be applied and any deviation must be requested by providing a clear description of the situation.