The European Union Penalties Regulation Explained by Hogan & Hartson Lawyers

After much debate about its content, purpose and legal basis, the European Commission Regulation on Penalties relating to new drug approvals was finally adopted on June 14, 2007 and entered into force on July 5, 2007. As a consequence of the Regulation, the European Commission can now impose fines on companies whose medicinal products have been authorized in accordance with the central procedure laid down in Regulation 726/2004 due to breaches of specified obligations. The level and nature of these fines, and their implications as compared to fines imposed by the European Commission for breach of antitrust rules is examined in this article.


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