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Coronavirus: Alternative Test Protocol (ATP) for surgical face masks

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.

Coronavirus: the FAMHP seizes postal packages containing counterfeit and other illegal medicinal products against COVID-19

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.

Nitrosamines in medicinal products: report results of risk assessments for impurities

Early October 2019, the European Medicines Agency (EMA), together with the European medicines authorities, including the FAMHP, asked marketing authorisation holders to perform a risk assessment on the presence of nitrosamines as a precaution. The results of these risk assessments can now be reported.

Coronavirus: ban on the sale of rapid diagnostic tests due to the risk of misinterpretation

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

Illegal skin whitening agents confiscated in Brussels

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.

Reporting quality defects in medicinal products via the FAMHP website

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.

Diabetes medicines with metformin: traces or nitrosamine contamination detected

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.

Simplified composition of preparations for treating coughs and colds from 1 January 2020

As of 1 January 2020, medicines with only one active ingredient can be sold for treating coughs and colds.

Watch out for identity theft for the illegal obtention of drug precursors

The FAMHP was confronted with a case of identity theft whereby company details where abused for the illegal obtention of drug precursors.

Ranitidine: recall of medicines

A nitrosamine impurity (NDMA, N-nitrosodimethylamine) has been detected in medicines based on ranitidine. The European Medicines Agency (EMA) has started a review. As a precautionary measure, the companies involved are recalling the medicine or placing the medicines in quarantine.

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