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Marketing authorisations of PMCs

During the transitional period between the legislation governing the PMCs (Presidi Medico Chirurgici, medical surgical aids) and the one about biocides, particularly pending the inclusion of all the active ingredients in the Union List, Member States may continue to apply their national laws.

In Italy, PMCs may be marketed only after prior registration at the Ministry of Health in accordance with the Presidential Decree 6 October 1998 no. 392 and the Ministry of Health Provision of 5 February 1999.

Only PMCs containing active substances under review for the specific product type (PT) and still under European assessment may be authorised. PMCs containing active substances with disinfectant activity on surfaces and/or healthy skin, or with insecticidal or insect repellent activities (which have become part of the Union List), shall be licensed as biocides in order to remain on the market.

For the purposes of the marketing authorisation as PMC, it is necessary to submit the relevant documentation to the Ministry of Health and the Italian High Health Institute (Istituto Superiore di Sanità – ISS).

Following the evaluation by both authorities, the authorised PMC will include the wording “Presidio Medico Chirurgico” and “Registration of the Ministry of Health N…” on the label.

Di Renzo Regulatory Affairs has a dedicated unit made up of regulatory experts in the field of biocides and PMCs. We can therefore assist companies in all required activities, including:

  • assessment of the preliminary documentation
  • preparation of the authorisation dossier for the competent authorities
  • submission of the PMC authorisation dossier
  • assistance during the whole authorisation procedure.