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Focus on Regulation

Tag Archives: benefits

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,

EMA’s reply to the EU Ombudsman inquiry on pre-submission interactions with medicinal product developers

The European Medicines Agency (“EMA”) has replied to a letter from the European Ombudsman opening a strategic inquiry into EMA’s pre-submission activities. Background information On 17 July 2017, Emily O’Reilly, the European Ombudsman, decided to conduct a strategic inquiry concerning EMA’s arrangements with individual medicinal products developers prior to the submission by these developers of