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In brief

On 17 May 2023, the European Medicines Agency (EMA) published on its website some recommendations for the industry on good practices to ensure continuity in the supply of human medicines, prevent shortages and reduce their impact.

Key takeaways

Said recommendations are addressed to marketing authorization holders, manufacturers and wholesale distributors and are based on the analysis of causes of shortages and the competent authorities’ experience in coordinating the management of shortages.

Recommendations include: (i) the timely notification of a potential or actual shortage to the National Competent Authority, providing detailed information to best anticipate the possible impact of the shortage and implement preventive measures; (ii) the adoption of a specific plan to prevent the occurrence of shortages, tailored according to the responsibilities of the different actors of the supply chain and aimed at identifying in advance the risks of supply chain interruption; (iii) the adoption of a plan to manage potential shortages and mitigate their impacts; and (iv) the improvement of communication among the different actors of the supply chain to enhance shortage prevention and mitigate the impact of actual shortages.


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.


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

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