Since the start of the coronavirus pandemic, the FAMHP teams have been working relentlessly to support hospitals and pharmacies facing difficulties in securing supplies of medicinal products. Here is an overview of the measures put in place by the FAMHP to guarantee stocks of medicinal products in Belgium.
Since the start of the coronavirus pandemic, the FAMHP teams have devoted a lot of resources to monitoring and supporting clinical research on COVID-19. Here is an overview of the measures implemented by the FAMHP.
Since the start of the coronavirus pandemic, the FAMHP teams have been working relentlessly to support hospitals facing difficulties with supplies of medical devices. Here is an overview of the measures implemented by the FAMHP.
Due to a worldwide increase in demand for the Gardasil 9 vaccine, used to prevent Human Papillomavirus (HPV), stocks of this vaccine are currently limited in Belgium. This limited availability has been extended and should continue until September 2020. The Federal Agency for Medicines and Health Products (FAMHP) has updated the recommendations for prescribers.
The Federal Agency for Medicines and Health Products (FAMHP) has authorized the first clinical trial evaluating a vaccine against COVID-19 in Belgium. This is the candidate vaccine from the German biotech firm CureVac.
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. These guidelines are intended for companies, institutions and authorities that order, sell or use these masks.
The new COVID-19 treatment recommendations from Sciensano strongly advise against any off-label use of hydroxychloroquine outside of a clinical trial. Applicants for ongoing clinical trials must also update their benefit-risk assessment and demonstrate to the FAMHP that their risk reduction strategies during the trial are sufficiently adequate.