Articles for the ‘Healthcare’ Category

In the ever-evolving world of medical device manufacturing, companies face the difficult task of ensuring innovation and progress every day. However, the pressure to use the latest technologies in healthcare is often in conflict with limited financial resources. In this complex environment, legal problems and risks often arise that can have a direct impact on pharmaceutical and medical device companies, hospitals and healthcare professionals. Pragmatic and safe legal solutions are required to resolve these issues.

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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.

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.