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In brief

With its circular letter dated October 21, 2020, the Ministry of Health clarified that, although surgical masks used by healthcare personnel classify as medical devices, the same are not subject to authorization for health advertising pursuant to Section 21 of Legislative Decree 46/1997, even where the relevant advertising message is addressed to the general public.With its circular letter dated October 21, 2020, the Ministry of Health clarified that, although surgical masks used by healthcare personnel classify as medical devices, the same are not subject to authorization for health advertising pursuant to Section 21 of Legislative Decree 46/1997, even where the relevant advertising message is addressed to the general public.


In this regard, the Ministry of Health pointed out that, although in the context of the current health emergency the use of surgical masks has been extended to citizens, this circumstance does not change the products’ intended use and that, under the existing legislation, authorization requirements do not apply to advertising messages relating to devices whose use is intended for health personnel.

Lastly, the Ministry of Health observed that a possible authorization requirement for the advertising of surgical masks would be inconsistent with the current regulatory framework under which other types of facial masks, whose use has been made mandatory to counter the spread of COVID-19 (i.e. PPE and “community” masks), would have free access to advertising.

Author

Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.

Author

Riccardo Ovidi is an associate in Baker McKenzie's Rome office.