According to the new Order SND/354/2020 of 19 April issued by the Spanish Ministry of Health, the pricing authority has 48 hours to set the maximum retail price of surgical masks, nitrile gloves, hygienic masks, antiseptics, hydroalcoholic gels and solutions as well as other (medical and non-medical) devices that are considered essential to minimize the risk of COVID-19 spreading among people. Additional measures relating to labeling and "control actions" of hygienic masks as well as the sale of surgical masks, which are not packaged individually have also been implemented.
According to the new Order SND/354/2020 of 19 April, in the next 48 hours the following products may be subject to price intervention by the pricing authority:
Medical devices, such as surgical masks and nitrile gloves;
Non-medical devices, such as hygienic masks, antiseptics, and hydroalcoholic gels and solutions;
Other (medical and non-medical) devices that are considered essential to minimize the risk of COVID-19 spreading among people (still to be determined by the authorities).
Measures applicable to hygienic masks (masks that are neither medical devices nor personal protective equipment as defined under the applicable regulations):
In addition to defining the mandatory information to be provided to consumers and other labeling obligations, Order SND/354/2020 provides for a series of "control actions" in respect of hygienic masks, including, among others:
Tests regarding technical specifications based on a standard, such as Bacterial Filtration Efficiency (BFE) and breathability (Differential Pressure), (Pa/cm2), must have been certified by a laboratory based on the technical specifications UNE-EN 14683:2019+AC:2019 or equivalent;
Any mask for which neither the material nor the mask itself has been verified by laboratory tests with respect to its filtration efficiency and breathability may not claim on its label any characteristics, which might lead to the interpretation that the product has properties for which no verification has been carried out, such as "protection against viruses" or similar.
Sale of surgical masks in pharmacies
With the purpose of ensuring adequate hygiene conditions, the unit sale of surgical masks that are not individually packaged may only be carried out through pharmacies.
Please contact us if you have any questions.
Authored by Santiago Garrido and Álvaro Abad