Share

21 March 2020Risk of a conviction for commercial fraud and imprisonment of up to two years, the owner of a well-known pharmacy in via Trionfale, reported in Rome, where yesterday the agents of the Administrative and Social Division of the police ascertained an illicit sale of masks produced handcrafted.

In the activity, controlled by investigators following the reports received from some citizens of the district north of the capital, a few thousand masks had been sold in a few days without the CE mark made by a small Roman tailor shop without not only certification but standards minimum hygiene and wholesomeness of packaged health devices.

If it is true, in fact, that the legislation on the emergency from coronavirus allows to produce, import and sell surgical masks in derogation from the rules that provided for the prior certification of the product through a notified body for the affixing of the CE mark, the manufacturer should have to send a self-certification to the Istituto Superiore di Sanità.

In this self-certification, it is foreseen by the aforementioned emergency legislation that the manufacturer - under his own exclusive responsibility - certifies the technical characteristics of the surgical masks he intends to produce and put on sale and declares that they comply with all the safety requirements referred to in specific legislation transmitting to the Institute every element useful for their validation.

The Higher Institute of Health, in turn, has 3 days to pronounce and where it does not recognize compliance with the legal requirements, orders the immediate withdrawal of the products from the market.