The European Commission’s proposal to amend the current pharmaceutical regulatory framework includes a draft Directive on medicines for human use (the “Proposed Directive”) and a draft Regulation on the central authorisation and supervision of medicines (the “Proposed Regulation”, together the “Proposal”). In this blog, we provide an overview of the potential impact of the Proposal
Valeria Sturla is a Legal Intern in the Life Sciences Practice Group.
Valeria completed a double degree in Law at the Universities of Milan (Università Statale di Milano), and Toulouse (Université Toulouse 1 Capitole). Valeria also completed the LL.M in European Legal Studies at the College of Europe of Bruges.
She is a native Italian speaker and fluent in English and French.
EU Pharma Legislation Review Series: Decentralized Manufacturing
The EU’s General Pharmaceutical Legislation amendment proposal, which was published on 26 April 2023 (“the Proposal”), is introducing new measures to regulate decentralized manufacturing, which is increasingly used for certain categories of medicinal products. In particular, the Proposal introduces new obligations for manufacturers and for national competent authorities overseeing decentralized sites. In this blog…
EU Pharma Legislation Review Series: Supply Security and Shortages Control
As part of the EU’s General Pharmaceutical Legislation amendment proposal, published on 26 April 2023 (“the Proposal”), 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”)…