Since the start of the coronavirus pandemic, the FAMHP teams have been working relentlessly and have devoted a lot of resources to monitoring medical devices delivered to Belgium and imported medicinal products.
The mission of the FAMHP is to ensure the safety, efficacy and quality of medicines and health products available on the Belgian market. It goes without saying that our inspectors have therefore had a lot of work to do to monitor the stocks of masks and other medical devices delivered to Belgium.
The FAMHP has also assisted the FPS Public Health in the search for suppliers of medical devices by verifying the compliance of offered medical devices and purchased surgical masks.
The FAMHP inspection departments have inspected more than 100 consignments for the FPS Public Health. These controls have helped to release more than 150 million face masks on the market, of which 131 million have been approved on the basis of the Alternative Test Protocol (ATP).
In addition, the FAMHP has analysed the compliance of more than 500 files relating to medical devices offered to the Belgian State. Most of the medical devices offered were surgical face masks, but also gloves and coveralls.
Controls and inspections to ensure the compliance of medical devices
Guidelines have been published on the FAMHP website to help companies, institutions and citizens to verify the compliance of these products.
In cooperation with customs, the FAMHP has conducted spot checks on the face masks placed on the European market in Belgium. More than 300 cases have been opened, more than half of which have already been definitively closed.
Increase in counterfeit and illegal medicinal products seizures
Unfortunately, the COVID-19 pandemic also proved to be a vulnerable time favourable for criminal organisations to sell counterfeit and other illegal medicinal products. Since the beginning of March 2020, FAMHP inspectors have noted an increase in the number of packages containing illegal medicinal products against COVID-19. These are fake, counterfeit or other illegal medicinal products whose quality, safety and efficacy have not been proven and which therefore pose a high health risk. Between March and early June 2020, 11,079 chloroquine tablets (or their derivatives) were seized. Numerous shipments of illegal Chinese cold and flu medicinal products or paracetamol-based preparations were also seized.
Millions of non-compliant surgical masks intercepted
To date, the FAMHP Special Investigation Unit (SOE-USE) has conducted around twenty investigations concerning unregistered Belgian distributors of non-compliant surgical masks. Until 3 June 2020, this led to four legal proceedings and several official warnings. These investigations led to the discontinuation of sale and distribution, the recall and the declassification of several million non-compliant surgical face masks.
In addition, the SOE-USE contributes to the actions of external partners (FPS Economy, Police, FPS Justice) and exchanges information on non-compliant medical devices and in vitro diagnostic devices with international colleagues.
You can find all information from the FAMHP concerning the measures taken during COVID-19 on our website.