BIOCIDES and PMC
The biocides are “ active ingredients and preparations containing one or more active ingredients, presented in the form in which they are delivered to the user, intended to destroy, eliminate, render harmless, prevent action or exert other control effect on any harmful organism by chemical means or biological “.
The use of biocides is widespread and covers industrial, professional and domestic sectors.
Regulation (EU) no. 528/2012 establishes that following approval (at European level) of the active ingredients contained in biocides, the products must be authorized before being placed on the market. The authorization is issued by one Member State, it can be recognized by other Member States (mutual recognition) or it can be requested at European level.
Furthermore, from 1 September 2015 only active ingredients whose supplier has been identified pursuant to Article 95 of the Regulation and is listed in the list of so-called active suppliers (recognized suppliers).
The medical and surgical devices (PMC) are disinfectants, insecticides, insect repellents and rat poison products that fall within the scope of application of Presidential Decree 392 of 6 October 1998.
The authorization procedures are different since we are in a transitional period for the recognition of active substances: if the active ingredients contained have not yet been approved according to the review program of the biocidal active ingredients, the product is governed by the national standard, which provides both the production authorization procedure and the marketing authorization procedure.
What we offer
ASSESSMENT OF OBLIGATIONS
Ensuring the continued commercialization of biocidal products requires knowledge of regulatory requirements in each territory, including scope issues, data requirements and presentation requirements, as well as careful monitoring of relevant active substances
We assist you in identifying products subject to the Biocides regulation or national legislation and we plan an action plan to meet the obligations
AUTHORIZATION OF BIOCIDE PRODUCTS
We prepare the dossier to be submitted for the authorization of biocidal products to the competent authorities, after having evaluated together with the company the costs, the test strategy and the authorization procedure to be followed.
Once the dossier has been sent, we will follow all exchanges with the authorities until the authorization is issued.
AUTHORIZATION OF MEDICAL SURGICAL DEVICES (PMC)
For products containing an active ingredient not yet approved, we assist in the
- Authorization of the production workshop,
- Choice of tests to be carried out for the activities covered by the claims on the product label,
- Verification and preparation of the documentation to support the request for authorization of the workshop and the medical surgical unit,
- Drafting and transmission of the authorization request for the workshop and the surgical medical unit
RENEWAL OF AUTHORIZATION OF MEDICAL SURGICAL DEVICES (PMC)
For PMC products already authorized we assist you in the procedures provided for by the Provision of 5 February 1999:
- Composition variation,
- Modification of the field and / or methods of use,
- Change of name of the PMC,
- Transfer of ownership of the marketing authorization,
- Change of the company name of the company that holds the marketing authorization,
- Change / extension of production workshops,
- Appointment / change of the Italian representative of a foreign company,
- Revocation of the Italian representative of a foreign company from the European Union,
- Size extension,
- New distributions,
- Change of the registered office of the company holding the marketing authorization,
- Formal change of label.
With the inclusion of treated articles in the scope of the EU Biocidal Products Regulation in 2013, both EU and non-EU bodies wishing to market goods containing preservatives may have new and complex obligations to understand and follow.
We assist you in arranging labeling and communication along the supply chain
The course explains the fundamental principles and main characteristics of the current biocidal legislation in Europe, introduces the authorization of products and the various procedures. It explains how a product is affected by the Biocides Regulation (BPR) and what to do to be compliant