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In brief

On 23 December 2021, the AIFA published a note providing clarifications on the renewal procedures for parallel import licenses of medicinal products (“AIP”). In this respect, the note clarifies that AIP holders must submit to the AIFA a renewal application for each authorized package at least nine months before the expiry of the validity of the relevant AIP, whose duration is five years from the date of publication in the Official Journal of the granting decree.

Where the holder does not intend to renew the AIP, it must promptly notify the AIFA’s Certifications and Parallel Imports Office and submit an application for withdrawal to the AIFA’s Product Quality and Fight against Pharmaceutical Crime Office.

In case the renewal application is not filed within the prescribed timeline, the relevant AIP shall be considered expired at the end of the fifth year from the date of publication of the granting decree pursuant to Article 38 of Legislative Decree No. 219/2006. In such a case, the AIP holder shall have a period of 90 days for the marketing of the relevant stocks, provided that the reference medicinal product on which the AIP is based is duly authorized at the time of the forfeiture.


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.


Riccardo Ovidi is an Associate in Baker McKenzie Rome office.

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