The Decree of March 29, 2023 established the progressive withdrawal of PMC products intended for disinfection of intact skin prior to medical treatment. This type of activity, previously authorized under the PMC regulation (D.P.R n. 392 of October 6, 1998), must now be referred to medicinal products.
The transitional period set by the decree will end with the withdrawal of the affected products from January 1, 2025, with the possibility of using lots already placed on the market until June 30, 2025.
The Health Commission of the Conference of Autonomous Regions and Provinces has requested an additional period for the marketing and use of disinfectants containing Chlorhexidine Digluconate at a concentration of 2%, in 100-250-500 ml packages, which are not authorized as medicinal products, in order to avoid potential supply issues on the market.
With the issuance of the Decree of December 24, 2024, a derogation has been granted until June 30, 2025, based on Article 55 of Regulation (EU) 528/2012, with the possibility of extension until July 5, 2026.
For further details on the implementation modalities and conditions to benefit from the derogation, download the text of the Decree: renderNormsanPdf.
