Presidi Medico Chirurgici and Transitional Regime

Presidio Medico Chirugico (PMC) are all products that claim an activity as:

• disinfectants and substances marketed as germicidal or bactericidal
• insecticides for domestic and civil use
• insect repellents

In order to be placed on the Italian market, PMC must contain an active ingredient under review in accordance with Regulation (EU) 528/2012 and must be authorised in advance by the Ministry of Health, after appropriate assessment of the documentation submitted by applicants.

Once authorised, the products must be labelled 'Presidio Medico-Chirurgico' and 'Ministry of Health Registration No. '......'

Registration as a PMC is necessary to put a product that meets the requirements on the market in Italy during the transitional period.

It also allows the product to remain on the market once the active-product type combination has been approved and the biocide dossier has been submitted correctly by the deadline.

By contacting our consulting team, you will be supported in the registration phase and in the optimization of testing with a view to the transition to the BPR

• Project management of product authorization projects
• Preparation of the authorization dossiers
• Submission of the authorization dossiers
• Liaison with regulatory authorities