Articles
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.
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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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Belgian Medicines Agency announces stricter monitoring of negative formulations on medicines packaging
On 17 May 2023, the Belgian Medicines Agency (FAMHP) announced that marketing authorisation holders (MAHs) have three years to comply with the prohibition of “negative formulations” on the packaging of medicinal products for human use. Such negative formulations include “gluten-free”, “lactose-free”, “ethanol-free” or “no colourings”. Apart from limited exceptions, MAHs will therefore need to remove such negative formulations from their current future packaging by 17 May 2026, and non-compliant formulations will be rejected.
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