On 1 August 2022, the Ministry of Health announced the launch of an administrative procedure aimed at verifying whether the conditions are met to maintain the validity of marketing authorisations as medical-surgical devices (PMC) for products intended for the disinfection of intact skin before a medical treatment.
Since the position expressed at the European level classifies disinfectants intended for use on intact skin prior to a medical procedure as medicinal products, it is likely that such products will no longer be authorised either as PMCs under Presidential Decree 392/98 or as biocides under Regulation (EU) 528/2012.
If, at the end of the evaluation, this interpretation is confirmed, PMC authorisations including this indication for use will no longer be valid and will need to be revoked.
To allow companies time to adapt and withdraw such products from the market, the provision will consider the possibility of granting a transitional period.
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