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In brief

On 28 September 2021, the European Commission launched a public consultation on the proposed revision of the current EU’s general legislation on medicines for human use referred to in Directive 2001/83/EC and Regulation (EC) 726/2004 in order to ensure a future-proof and crisis-resistant medicines regulatory system.

The purpose of the consultation, which will be open for replies until 21 December 2021, is to collect contributions from stakeholders and the general public in order to support the Commission’s impact assessment of revisions and to define the text of the legislative proposal, whose adoption is planned for the fourth quarter of 2022.

In particular, the consultation addresses the following issues: access to affordable medicines, promotion of innovation, including in areas of unmet medical need; improvement of security of supplies; adaptation to new scientific and technological developments, and reduction of red tape.


Roberto Cursano is a counsel in Baker Mckenzie since 2007 in Rome, Italy office. His practice focus more in pharmaceutical and healthcare law matters and compliance, and assists in tender procedures, the negotiation of public contracts and litigation before administrative courts.


Riccardo Ovidi is an associate in Baker McKenzie's Rome office.

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