How is the Belgian Federal Agency for Medicines and Health Products playing its part to combat COVID-19?

In the current situation of progressive confinement de-escalation, shortages of basic-need products against COVID-19 are not welcomed at all. Precisely, the health authorities of the EU Member States have been adopting different measures to avoid such scarcities.

Do you want to know more about the FAMHP activities on the Belgian market? This article is for you!


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

While some of the surgical face masks marketed in Belgium have been found as lacking the declarations, certificates and test reports needed to demonstrate compliance with EU or International Standards (EN 14683: 2019 + AC: 2019, ASTM F2100, YY 0469: 2011 and YY / T 0969-2013), an Alternative Test Protocol (ATP) has been set up to guarantee their continuity on the market for the benefit of the population in view of the high demand.

Consequently, apart from the guidelines for checking the compliance and suitability of certain surgical face masks published on 30 March 2020, manufacturers have now at their disposal the Alternative Test Protocol (ATP). This consists of a simplified test protocol that only considers the results of two important parameters: the bacterial filtration efficiency and differential pressure tests.

In this light, it will depend on the results obtained from the ATP whether the face masks are pondered as comfort mask or surgical face mask. Besides, in virtue of this newly authorized Alternative Test Protocol it will be possible to determine if non-compliant masks, which would certainly not be accepted under normal circumstances, are of enough quality to be used in the contemporary crisis.

Nevertheless, both manufacturers and importers should bear in mind that this is an exceptional and temporary solution to address the COVID-19 outbreak. Therefore, manufacturers will have to comply with specific requirements in the future, regardless of whether their masks have undergone the ATP or not.


Carlos Francisco Marín Barrios

Regulatory Affairs Department

13/05/2020


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