Medical-surgical aids (presidi medico chirurgici – PMC) include products such as disinfectants, insecticides, insect repellents, rat poisons, that require a national authorisation from the Ministry of Health for their marketing.
Before establishing this, one should check the regulations in force in that particular country where the product is to be marketed. Each country has its own regulation and therefore not all products that should be registered as PMC in Italy must necessarily follow a similar procedure in other countries.
Our company is able to provide specific and updated information on the status of the single active substances and on the regulations in force. We offer effective support in the preparation of a biocidal dossier assisting your company through the whole authorisation procedure.
The Commission adopts an implementing regulation establishing the conditions based on which an active substance is approved or an implementing decision according to which an active substance is not approved.
It must be assessed if the intended use of that product falls in the classification of the PTs (Product Types) and if the active substances are included in the EU list for that particular PT.
In case an active substance is excluded from Annex II and is not included in the EU list for a specific PT, it will not be possible to authorise a product as a biocide containing that active substance for that particular intended use and it will be required to withdraw all PMCs or free sale products with biocidal properties containing this active substance from the market.
This is the review program of all active substances regarding all active substances on the market before 14th May 2000. The scope of this program is to identify, notify and group those substances whose use is considered suitable in the preparation of biocides.
According to the definition of Regulation (EU) no. 528/2012, biocidal product means any substance or mixture generated from substances or mixtures or in the form in which it is supplied to the user, consisting of, containing or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism by any means other than mere physical or mechanical action. A treated article that has a primary biocidal function shall be considered a biocidal product.
The authorisation is released for a maximum period of 10 years. An application to renew this authorisation is to be submitted if one intends to continue the marketing of the biocidal product.
No. When the active substance of the PMC is approved for biocidal use, the submission of a new application to authorise the MS as biocidal product is required, otherwise the PMS must be withdrawn from the market.
No. Only those approved and reported in the List of Article 95 can make biocidal active substances available.
No. The dossier required to authorise a product as a biocidal is more substantial than that of a PMC. In fact, it also includes studies to determine the chemical and physical properties and the efficacy of the product as well as ecotoxicological studies. Moreover, the biocidal dossier must be prepared and submitted via the specific programs.
An evaluation is required whether the active substance was approved for the intended use of the concerned product.