Pharma D&S




Biocides and medical devices

The term biocides refers to active substances and preparations containing one or more active substances intended to destroy, eliminate, make harmless, prevent the action or exert a controlling effect on any harmful organisms by chemical or biological means. The European regulation breaks them down into 23 product type, divided into 4 groups.

In Italy, some categories of these products fall within the Medical device sector, whilst others, until implementation of the biocides regulation, are for free sale.

In 1998, the approval of Directive 98/8/EC, relating to the placing on the market of biocidal products, started up a harmonization process involving the various national rules, which provides that the active substances, to be used in biocidal products, should be included in positive lists. Such lists indicate the conditions for the inclusion of each single active ingredient into a product and the type/s of product wherein it can be included.

The development process leading to the formation of these lists is long and still in progress, as a specific evaluation for each active substance present on the market as from the effective date of Directive 98/8/EC (May 14th 2000) as well as for any new active substance is scheduled. This evaluation may result in the inclusion of the active substance in the list of the usable ones, by specifying the type of use, modalities and restrictions, or may lead to a non-inclusion decision, with the consequent marketing prohibition for all products containing such substance.

Once the decision to include the product in the list has been taken, the term within which all companies marketing products containing such active substance should register them by submission of a technical dossier is set, whilst, in case of a non-inclusion decision, the term within which products should be recalled is established.



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