Photo of Valeria Sturla

Valeria Sturla

Valeria Sturla is an associate in the Life Sciences team. She advises clients across a wide range of regulatory and compliance issues in the pharmaceutical, food, and cosmetics sectors, and her practice focuses on EU, French and Belgian regulatory advice. Valeria has also assisted in several litigations before the Court of Justice of the European Union, including as part of pro bono efforts. She is a native Italian speaker and fluent in English and French.

Contact:Read more about Valeria SturlaEmail

As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“theProposal”), the European Commission (“Commission”) has introduced a series of measures aimed at securing the supply of critical medicinal products across the EU and at preventing shortages.  In particular, there are new obligations for Marketing Authorization Holders (“MAH”) and competent authorities are given more power to better monitor and control the availability of medicines on the market.

As we have discussed previously, these measures aim to tackle the broader problem of security and robustness of pharmaceutical supply chains, which became especially prominent during the COVID-19 pandemic.  In this blog, we briefly explore some of the changes introduced by the Proposal.

Preventing Supply Disruptions and Shortages

Critical Medicinal Products

The Proposal expands the monitoring of “critical medicinal products” beyond emergency situations.  Now, medicinal products “for which insufficient supply results in serious harm or risk of serious harm to patients” will be included in the “Union list of critical medicinal products” (“Union list”), and the Commission will have the power to implement measures such as stockpiling of active pharmaceutical ingredients or finished dosage forms.  Continue Reading EU Pharma Legislation Review Series: Supply Security and Shortages Control