Articles for the ‘Healthcare’ Category

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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