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In brief

In its press release No. 642 of 12 April 2021, the Italian Medicines Agency (AIFA) indicated a substantial increase of reports concerning medicinal products purchased online from unauthorized channels that were found to be falsified or illegal. The most recent cases include purchases of products with anti-cellulite activities and medicines used in the treatment of erectile dysfunctions.


In the above-mentioned press release, the AIFA reiterated the need for consumers to pay the highest attention when purchasing medicines online, especially during the current COVID-19 health emergency during which illegal anti-COVID vaccines could be offered without any guarantee in terms of quality, efficacy and safety and, therefore, potentially highly dangerous, as already occurred in several non-European countries. In this regard, the AIFA also stressed the importance of cooperation of private citizens, health professionals, companies and associations in reporting suspected cases so that all necessary measures can be implemented to protect public health and the health of the individual.

Lastly, the AIFA reiterated that, pursuant to the existing legislation, the online sale of medicines to the public is restricted to pharmacies, para-pharmacies or “health corners”, as identified in article 5, paragraph 1, of Law Decree No. 223/2006, and only for prescription-free medicines, with the exclusion of e-commerce platforms.

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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