Ascensionato R. Carnà, Ph.D.
Managing Partner
Studio Carnà
Milan – Rome – London Barcelona – Lugano

The Belgian Ministry of Public Health adopted the “Sunshine Act”, a chapter of the “Health Law” published on 18 December 2016 and containing various provisions on health-related matters. This law introduces a number of changes to the legal and regulatory framework for medicinal products and medical devices.

The Act contains obligations for pharmaceutical and medical devices companies to document and disclose information regarding benefits and premiums granted directly or indirectly to healthcare professionals and healthcare institutions (“transfers of value”).

The Act specifies that the notification obligation more broadly applies to “all entities engaged in an economic activity”. In particular, those subject to the notification obligation are:

• all marketing authorisation holders for medicinal products for human or veterinary use, 
• all importers, manufacturers and distributors of medicinal products for human or veterinary use
• all persons or entities trading or brokering medicinal products for human or veterinary use and 
• all distributors, retailers and manufa ...
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