Articles
New product liability regime on the way
The European Commission published a draft proposal for a revised Product Liability Directive (the “PLD Proposal”) on 28 September 2022, which aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global value chains.This blog focuses on the main changes the PLD Proposal brings and its impact on life science companies.
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Bolar Provision in Ukraine: Update Required
The so-called Bolar provision is generally understood as the rule allowing generic and biosimilar manufacturers to get prepared for launching a drug by the time the relevant patent expires, thereby offering broader options to patients as early as possible.
... Read moreThe Commission’s upcoming Guidelines for Abuse of a Dominant Position under Article 102 TFEU has raised a lot of attention
A New Approach for Assessing Alleged Abuse of a Dominant Position under Article 102 TFEU? Many pharmaceutical companies risk facing acquisitions regarding abuse of a dominant
... Read moreCJEU interprets the concept of a global MA strictly
On 16 March 2023, in Joined Cases C‑438/21 P to C‑440/21 P, the Court of Justice of the European Union (CJEU) interpreted the concept of a global marketing authorisation.
... Read more Telemedicine: legal framework in Europe & Israel
Updated study as of June 2023, on the legal recognition, possible regulation and main characteristics of telemedicine in different European countries and Israel.
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