Dossiers and authorisation procedure for PMCs
The legislation on PMCs applies to the following types of product sold in Italy:
- disinfectants and substances placed on the market as germicides or bactericides;
- insecticides for domestic and civil use;
- insect repellents;
- rat and mice poisons for domestic and civil use.
When a product contains an active substance still under evaluation at European level for one of the PTs of the classes listed above, it should follow the authorisation procedure provided for by the PMC legislation in order to be marketed in Italy.
The main services offered in this field are:
- preliminary evaluation, preparation and submission of a dossier for the authorisation of a PMC and assistance in the relative authorisation procedure
- identification of studies to be performed (chemical and physical analyses, efficacy studies, etc.) according to the active ingredient and the intended use of the product
- contacts with testing laboratories for test performance
- preparation and verification of PMC labels in accordance with current legislation
- assistance with the review of advertising messages and with the advertising authorisation application
- assistance with the authorisation application for the manufacturing of PMCs
- notification into the Dangerous Preparations database of the High Health Institute (ISS)
- translations of texts and labels into/from several languages including: Italian, English, Spanish, French, German etc.
