Articles for the ‘Life Sciences’ Category
Belgium aims for hospitals to increase their biosimilars uptake
Published 30 November 2023 by Belgium aims for hospitals to increase their biosimilars uptake
ALTIUS Lawyers, Belgium
Despite many initiatives by the (former) Minister of Health, the uptake of biosimilars in Belgium has remained rather low. In this blog, we summarise the new rules, which apply since 2 October 2023.
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New product liability regime on the way
Published 16 October 2023 by New product liability regime on the way ALTIUS Lawyers, Belgium
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.
... Read more CJEU interprets the concept of a global MA strictly
Published 05 July 2023 by Kirian Claeyé
ALTIUS Lawyers, Belgium
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 Belgian Medicines Agency announces stricter monitoring of negative formulations on medicines packaging
Published 14 June 2023 by Kirian Claeyé ALTIUS Lawyers, Belgium
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.
... Read more State Aid in Life Sciences in Israel
Published 01 August 2016 by Yuval Horn
Horn & Co. Law Offices, Israël
What is the size of the market, and what are current trends in Israel? What kind of State aid schemes for life sciences exist in Israel?
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