During the transitional period between the legislation governing the presidi medico chirurgici(PMC) and biocides, particularly pending the inclusion of all the active ingredients in the Union list, Member States may continue to apply their national laws.
In Italy PMC may be marketed only after prior registration with the Ministry of Health in accordance with the Presidential Decree n. 392 of the 6 October 1998 and the Provision of the 5 February 1999.
Only PMC containing active substances under review for the specific product type (PT) may be authorised. PMC containing active substances with biocidal activities (which have become part of the Union list), must be licensed as biocides in order to remain on the market.
For the purposes of the marketing authorisation as a PMC it is necessary to submit the relevant documentation to the Ministry of Health and the Istituto Superiore di Sanità (ISS). Following the evaluation by both the authorities, the authorised PMC will include the words “Presidio Medico Chirurgico” and “Registration of the Ministry of Health N…” on the label.