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In brief

On 11 July 2022, the Ministry of Health published the “Annual National Plan of Transitional Controls on Biocidal Products” (“Plan“) on its website, whose purpose it is to coordinate and integrate the organization of controls on biocidal products through the harmonization of control strategies and operating procedures.


Key Takeaways 

The strategic objectives of the Plan include the protection of the health of end users of biocidal products through the verification of the products’ compliance with the existing legislation and the fight against fraudulent and illegal practices that are potentially detrimental to the health of consumers, through cooperation and coordination both at the national level, between state and regional administrations and agencies, and at the international level, between the competent authorities of EU member states.

To achieve the above objectives, the Plan envisages the performance of checks on the entire management process of biocides, including that relating to manufacturing and marketing. These include the performance of controls aimed at verifying the compliance of biocidal products with authorization requirements, the compliance and availability of the Safety Data Sheet and the Summary of Biocidal Product Characteristics, the identification of production batches and their expiration, and the classification of the products’ labeling and packaging.

Author

Roberto Cursano has been a lawyer in Baker McKenzie since September 2007. He focuses on healthcare law and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts. Mr. Cursano is a former administrative officer in the Italian Ministry of Health and helps clients work closely with the Italian Public Administration. He is admitted to the bar before the Italian Supreme Court and the Council of State. As well as training and tutoring in the master’s degree program on clinical trials of pharmaceutical products at the University of Rome Sapienza, Mr. Cursano regularly publishes articles and scientific contributions. He also frequently hosts and participates in seminars and presentations on pharmaceutical and administrative law matters.

Author

Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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