Di Renzo SRL employs third party cookies allowing the latter to access to personal data collected during navigation. For more information, consult the extended disclosure pursuant to Art. 13 of the Data Protection Code. The user is aware that, following  Website Navigation, they accept the use of cookies.

Presidi medico chirurgici and biocidal products

Biocides and PMC

The so-called presidi medico chirurgici (PMC, literally meaning medical-surgical aids) are a series of products and substances placed on the market such as germicides or bactericides, insecticides, rat poisons for domestic and civil use and insect repellents

The national legislation governing the marketing of these products will be completely replaced by the European legislation on biocidal products, entailing the integration of presidi medico chirurgici into the category of biocidal products.

The list of active ingredients present in products on the market is under review at the European level and, once approved, will be subsequently used for the preparation of biocides.

The availability on the market and use of biocidal products, as of the 1 September 2013, is subject to the Regulation of the European Parliament and of the Council no. 528/2012 of 22 May 2012, which repealed Directive 98/8/EC and that has been partially modified by the Regulation (EU) n. 334/2014.
A definitive list of active ingredients, the use of which is accepted in Europe, is expected to be completed by the 31.12.2024, as determined by the Delegated Regulation (EU) 736/2013.

With the entry into force of Regulation 528/2012, Annex I of Directive 98/8/EC (that containing the authorised active substances) has been replaced by the Union list. The PMC, which are currently on the market containing the active ingredients included in this list will have to be newly authorised in accordance with the biocide regulations.

As a consultancy company, we are able to offer advice to companies wishing to market their biocidal products and PMC, providing accurate and up to date information on the status of the individual active substances and existing legislation, accompanying companies through the complex process of marketing authorisation during the biocide-PMC transition period, and prepare the dossier for authorisation for formulations as biocides.

In particular, Di Renzo Regulatory Affairs is able to offer the following services:

Presidi medico chirurgici (PMC)

  • Advice on Italian and European regulations in force and on the evolution of the legislation on biocides, in particular on the period of transition PMC-biocides;
  • Verification of the inclusion of the active substances in the Union list in order to classify the product as a PMC / biocide / product of free sale or otherwise in accordance with the Italian and European regulations (feasibility study);
  • Verification of the requirements for the registration in European countries and in some non-EU countries;
  • Assistance with the preparation and submission of the registration dossier at the competent authorities and relevant authorisation process for a PMC;
  • Assistance with the preparation of the dossier for the manufacturing authorisation of the PMC and its authorisation procedure at the Ministry of Health;
  • Evaluation of advertisements to the general public relating to PMC and to biocides and the authorisation process for the advertising of PMC;
  • Translations of texts and labels to / from the following languages: Italian, English, Portuguese, Greek, Spanish, French, German;
  • Training courses on Italian and European regulations relating to PMC and biocides;
  • Request for certificates of free sale for PMC;
  • Development of mock-ups of labels, logos, design and development of brochures, leaflets and advertising material;
  • Registration of trademarks and patents for any type of device or process, even relative to PMC and biocides.

Biocidal products

  • Advice on Italian and European regulations in force and on the evolution of biocides legislation;
  • Verification of the inclusion of the active substances in the approved list in order to classify the product as an PMC / biocide / product of free sale or otherwise in accordance with the Italian and European European (feasibility study);
  • Verification of the requirements for the registration in European countries and in some non-EU countries;
  • Preliminary evaluation, preparation and submission of a dossier for the authorisation of a biocidal product in accordance with the legislation in force, in all its parts and assistance in the relative authorisation procedure;
  • Identification of studies to be performed (chemical and physical analysis, stability studies, toxicological and ecotoxicological studies, efficacy studies, etc.) according to the Product Type (PT) of interest, the active ingredient and the intended use of the product;
  • Preparation and verification of labels of biocides in accordance with current legislation;
  • Translations of texts and labels to / from the following languages: Italian, English, Portuguese, Greek, Spanish, French, German;
  • Training courses on Italian and European regulations relating to PMC and biocides;
  • Development of mock-ups of labels, logos, design and development of brochures, leaflets and advertising material;
  • Registration of trademarks and patents for any type of device or process, even relative to the PMC and biocides.