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In brief

With judgment No. 8656 published on May 22, 2023, the Administrative Court of the Lazio Region ruled on the legitimacy of the decision whereby the AIFA rejected an application for the renewal of a Parallel Import Authorization (PIA) filed by a pharmaceutical company that had carried out re-packaging operations consisting in the opening of the aluminum envelopes containing the blisters and the removal of one tablet per blister.


Key takeaways 

The AIFA rejected the application arguing that the re-packaging activity was contrary to the existing regulatory framework and to the “Instructions for Application for Parallel Import Authorization” issued by the same AIFA pursuant to which, on the one hand, re-packaging must not alter the original state of the product and, on the other hand, manufacturing operations reducing the authorized period of validity are not acceptable. In this regard, the AIFA considered that the opening of the blister affected the validity period of the medicines and that, therefore, its re-packaging was not allowed.

Based on the above, the Administrative Court dismissed the appeal claiming that the rejection of the renewal application was in line with the applicable regulatory framework and the case law on the matter according to which changes to medicines resulting from their re-packaging cannot affect their quality, safety and efficacy.

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.

Author

Francesca R. Baratta is an Associate in Baker McKenzie Rome office.

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