The European Medicines Agency (EMA) issued a positive opinion for “COVID-19 Vaccine Moderna”, making it the second COVID-19 vaccine to be authorised for marketing in the European Union. This recommendation still has to be confirmed by the European Commission. Belgium has purchased the vaccine and will use it in its vaccination campaign.
In April 2020, the Belgian Federal Agency for Medicines and Health Products (FAMHP) and Sciensano set up an extraordinary validation procedure for serological tests for SARS-CoV-2. The procedure turned out to be effective during the initial phase of the pandemic. The situation being experienced by the manufacturers and distributors of these tests and by the clinical laboratories carrying out the tests has now returned to normal. This is why a staged return to the conventional way of working is now being implemented.
The FAMHP is keeping a close eye on the situation on the ground. Consequently, the Alternative Test Protocol (ATP) is being adapted. From now on, it will no longer be possible to sell surgical masks which do not comply with the ATP as comfort masks. One of the parameters has also been refined based on an evaluation of the new test results. Furthermore, masks that have been subject to the ATP must carry a warning on the packaging. The third version of the ATP is applicable from 04.06.2020.
The FAMHP has issued guidelines for checking the compliance and suitability of surgical face masks during the COVID-19 crisis. The guidelines are intended for companies, institutions and authorities that order, sell or use these masks.
In anticipation of the European regulations on medical devices (Regulation (EU) 2017/745) and in vitro diagnostic medical devices (Regulation (EU) 2017/746), the FAMHP has updated the “My company” and “My activities” applications in its web portal.
Belgian manufacturers of COVID-19 tests for professional use and Belgian authorised representatives of foreign manufacturers must notify the FAMHP when placing their tests on the market. This notification does not constitute an offer of equipment to the Belgian state. Companies wishing to offer tests to the government must contact the FPS Public Health.
An Alternative Test Protocol (ATP) has been developed for surgical face masks that do not have the necessary declarations, certificates and test reports. In the event of a positive result, this protocol still allows them to be used as a surgical mask or comfort mask. Test results are now also made public.
Following the recommendations of the Belgian National Security Council regarding the coronavirus epidemic, the FAMHP encourages employees to work more from home. Therefore, we ask all our partners to submit their files to us electronically as much as possible.
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.
Implants and certain invasive medical devices: as of June 3, 2019, the FAMHP takes over the RIZIV notification database.
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).