Articles for the ‘Medicines’ Category

Changes in the law on marketing of veterinary medicines: what you need to know

Published 06 February 2024 by Christophe Ronse ALTIUS Lawyers, Belgium

Belgium is welcoming a significant development in the field of veterinary medicine law. The Act of 11 July 2023 containing various provisions on health, which entered into force on 8 September 2023, introduces changes across a wide spectrum of healthcare domains, which are encompassed in approximately 20 chapters. In this blog post, we provide an overview of the key changes related to the marketing of veterinary medicines set out in Chapters 4 and 14 of the new Law.

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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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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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