The national legislation D.P.R. n. 392 of October 6th 1998, that regulates the marketing of Presidi Medico Chirurgici (PMC) identifies 4 different product categories:

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

This national legislation by 2024 will be, entirely or almost, repealed by the EU Regulation 528/2012, resulting in the need to authorize these products according to European provisions.

The submission of authorization dossiers within the deadlines defined by the progress of the review program of active substance/product type combinations (PT), allows to access to the transitional regime for the marketing of all products registered as PMC by the Italian Ministry of Health.

Failure to submit the dossier implies the need to remove products from the market, whether they are registered as PMCs or as free sale products.

Despite the fact that the date of repeal of the Italian legislation is getting closer every year, the SARS-CoV-2 pandemic has highlighted the need to authorize PMCs in order to benefit from the transitional regime provided by Regulation 528/2012.

The Biocides mastery division since 2008 has gained considerable experience in the authorization of PMCs, offering to our customers the following services:

  • definition of the regulatory strategy for product authorization
  • organization of PMC dossier
  • authorization of manufacturing site
  • modification of PMC authorizations already granted
    • change of composition
    • change of field and/or method of use
    • change of trade name
    • transfer of ownership
    • change of company name
    • change of registered office
    • change/extension of manufacturing site
    • change/extension of packaging sizes
    • change/extension of authorized distributors
  • authorization of advertising of PMC products
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