Articles for the ‘Pharma law’ Category

The 5 major changes in Belgian pharma law of 2023

Published 21 December 2023 by Kirian Claeyé ALTIUS Lawyers, Belgium

Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law.

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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.

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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.

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