News FAMHP

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 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 Committee for Advanced Therapies (CAT) of the European Medicines Agency (EMA) advises patients and citizens not to use unregulated cell therapies, which may be unsafe or ineffective.

The European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) has recommended that the sale of all ranitidine-based medicinal products be suspended in the European Union. This is due to the presence of low levels of an impurity called N-nitrosodimethylamine (NDMA).

The FAMHP inspection services have noted that the surgical face masks offered do not have the declarations, certificates and test reports necessary according to European or international standards. For this reason, an Alternative Test Protocol (ATP) has been developed to ensure they can still be permitted for use as a surgical mask or comfort mask.

Criminal organisations are using the coronavirus pandemic to sell counterfeit medicinal products and other illegal medicinal products. The FAMHP asks patients to be prudent and be careful of internet deals.

In order to avoid misinterpretation of negative results, the FAMHP has banned the use of rapid coronavirus (COVID-19) diagnostic tests for six months.

More than 1 800 illegal skin whitening agents were confiscated in seven shops in a coordinated action in Brussels. The vast majority are skin whitening agents containing corticosteroids which are very popular among the African community. The substances can cause severe side effects such as infections, scarring or adrenal gland insufficiency.

Quality defects in medicinal products can impact patients’ health or make it difficult for healthcare professionals to administer them. Quality defects can be reported via the FAMHP website.

The European Medicines Agency (EMA) and the competent medicine authorities of the European member states, including the FAMHP, have been notified that in a small number of diabetes medicines based on metformin outside of the European Union, a nitrosamine contamination (NDMA, N-nitrosodimethylamine) has been detected. Currently, analyses are being performed on the medicines within the European Union.