The new law decree passed by the Italian Government (Law Decree no. 18 of 17 March 2020 - so called Cura Italia) contains, inter alia, interesting measures aimed at tackling the shortage of protective masks and other personal protection equipment (PPE) during this challenging period.
Pursuant to Article 15, until the end of the state of emergency 1, it is allowed to manufacture, import and put on the market surgical masks and PPE “by way of derogation from existing legislation”.
Companies wishing to make use of the above exemption will be enabled to avail themselves of a fast-track procedure in order to obtain the validation of their products by the competent authority – ie the National Health Institute - (Istituto Superiore di Sanità - ISS) for surgical masks, or the National Institute for Insurance against Accidents at Work (Istituto Nazionale per l’Assicurazione contro gli Infortuni sul Lavoro - INAIL) for PPE, as the case may be.
In particular, the validation procedure foreseen in Article 15 consists of the following three stages:
Manufacturers and importers must send to the competent authority a self-certification in which, under their own exclusive responsibility, they attest the technical features of the masks/PPE and declare that the products comply with all the safety requirements under current legislation.
Manufacturers and importers, within and no later than 3 days from the aforementioned self-certification, must also provide the competent authority with every element useful for the validation of the products covered by the same.
Within 3 days of receipt of the supporting elements under point 2 above, the competent authority shall issue its opinion regarding the compliance of the products with applicable safety standards.
If, at the end of the above assessment procedure, the products are found to be non-compliant with current regulations, without prejudice to the application of the provisions on self-certification, the manufacturer must immediately cease production and the importer is prohibited from placing the products on the market.
In addition to the above, as of 22 March 2020, following approval by the European Commission of the €50m support scheme proposal contained in Article 5 of the Cura Italia decree, financial support – in the form of direct grants or repayable advances – is also available to Italian companies wishing to expand or convert their production line for manufacturing medical devices and PPE.
1 On 31 January 2020, the Italian government declared a six-month state of emergency in response to the first confirmed cases of the new coronavirus in the country
