New procedures for the drafting and submission of authorization procedures for biocidal products and Presidi Medico Chirurgici
The Italian Ministry of Health has communicated that starting from the 8th of March 2022, the procedures of authorization for the placing on the market of biocidal products and Presidi Medico Chirurgici and authorization for the production of PMCs and related amendments, issued by Office 8 “Biocides and cosmetics” of the “Direzione Generale dei Dispositivi Medici e del Servizio Farmaceutico”, in accordance with Regulation (EU) 528/2012 and the Presidential Decree of 6 October 392/1998, are now signed by digital signature.
The documents with digital signature are transmitted by certified electronic e-mail or, in any case, by telematic means, allowing faster notifications and benefit in terms of procedural management times.
