{"id":1971,"date":"2021-01-29T10:25:03","date_gmt":"2021-01-29T09:25:03","guid":{"rendered":"https:\/\/www.chemicalsconsulting.eu\/biocides-and-medical-surgical-devices\/"},"modified":"2021-02-02T12:37:40","modified_gmt":"2021-02-02T11:37:40","slug":"biocides-and-medical-surgical-devices","status":"publish","type":"page","link":"https:\/\/www.chemicalsconsulting.eu\/en\/biocides-and-medical-surgical-devices\/","title":{"rendered":"BIOCIDES and PMC"},"content":{"rendered":"

[vc_row full_width=”stretch_row”][vc_column][st_customheading heading=”BIOCIDES and PMC” content_align=”text-left”][vc_column_text]The biocides are “ active ingredients and preparations containing one or more active ingredients, presented in the form in which they are delivered to the user, intended to destroy, eliminate, render harmless, prevent action or exert other control effect on any harmful organism by chemical means or biological<\/em> “.<\/p>\n

The use of biocides is widespread and covers industrial, professional and domestic sectors.<\/p>\n

Regulation (EU) no. 528\/2012 establishes that following approval (at European level) of the active ingredients contained in biocides, the products must be authorized before being placed on the market. The authorization is issued by one Member State, it can be recognized by other Member States (mutual recognition) or it can be requested at European level.<\/p>\n

Furthermore, from 1 September 2015 only active ingredients whose supplier has been identified pursuant to Article 95 of the Regulation and is listed in the list of so-called active suppliers<\/em> (recognized suppliers).<\/p>\n

The medical and surgical devices (PMC) are disinfectants, insecticides, insect repellents and rat poison products that fall within the scope of application of Presidential Decree 392 of 6 October 1998.<\/p>\n

The authorization procedures are different since we are in a transitional period for the recognition of active substances: if the active ingredients contained have not yet been approved according to the review program of the biocidal active ingredients, the product is governed by the national standard, which provides both the production authorization procedure and the marketing authorization procedure.[\/vc_column_text][vc_empty_space height=”60px”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1513070457262{background-color: #3a526a !important;}”][vc_column][st_customheading heading=”What we offer” heading_color=”#ffffff” content_align=”text-default”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1512566891792{background-color: #3a526a !important;}”][vc_column width=”1\/4″][vc_column_text]ASSESSMENT OF OBLIGATIONS<\/strong><\/span><\/p>\n

[\/vc_column_text][\/vc_column][vc_column width=”3\/4″][vc_column_text]Ensuring the continued commercialization of biocidal products requires knowledge of regulatory requirements in each territory, including scope issues, data requirements and presentation requirements, as well as careful monitoring of relevant active substances<\/span><\/p>\n

We assist you in identifying products subject to the Biocides regulation or national legislation and we plan an action plan to meet the obligations<\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1512567399272{background-color: #3a526a !important;}”][vc_column][vc_separator color=”white”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1512567448946{background-color: #3a526a !important;}”][vc_column width=”1\/4″][vc_column_text]AUTHORIZATION OF BIOCIDE PRODUCTS<\/strong><\/span>[\/vc_column_text][\/vc_column][vc_column width=”3\/4″][vc_column_text]We prepare the dossier to be submitted for the authorization of biocidal products to the competent authorities, after having evaluated together with the company the costs, the test strategy and the authorization procedure to be followed.<\/span><\/p>\n

Once the dossier has been sent, we will follow all exchanges with the authorities until the authorization is issued.<\/span>[\/vc_column_text][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1512567399272{background-color: #3a526a !important;}”][vc_column][vc_separator color=”white”][\/vc_column][\/vc_row][vc_row full_width=”stretch_row” css=”.vc_custom_1512567448946{background-color: #3a526a !important;}”][vc_column width=”1\/4″][vc_column_text]AUTHORIZATION OF MEDICAL SURGICAL DEVICES (PMC)<\/strong><\/span>[\/vc_column_text][\/vc_column][vc_column width=”3\/4″][vc_column_text]For products containing an active ingredient not yet approved, we assist in the<\/span><\/p>\n