Header graphic for print
Focus on Regulation

Tag Archives: Belgium

Belgian sunshine rules – Submissions required by 31 May 2018 at the latest

On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act”) was adopted by the Belgian Ministry for Public Health. The Sunshine Act provides that life sciences companies must publically disclose information concerning all pecuniary advantages or benefits in kind granted, directly or indirectly from Belgium or elsewhere,

New Belgian Sunshine Requirements applicable to all pharmaceutical and medical devices from 1 January 2017

On 27 December 2016, the Belgian Law of 18 December 2016 concerning various health-related matters (“the Sunshine Act “) was adopted by the Belgian Ministry for Public Health[1].  The Sunshine Act introduces several substantial changes to the current Belgian legal and regulatory framework for medicinal products and medical devices. Background The Sunshine Act imposes a

New Belgian Innovation Office to Accelerate Availability of Novel Medicines

In July 2016, the Belgian Agency for Medicines and Healthcare Products (“FAMHP”) took steps to establish a National Innovation Office as part of the European Union (“EU”) Innovation Network. The National Innovation Office is currently being established by the FAMHP. It is expected to become functional in the first quarter of 2017. The National Innovation