The European Union Penalties Regulation explained by Hogan and Hartson lawyers

After much debate about its contents, purpose and legal basis, the European Commission Regulation on Penalties relating to new drug approvals was finally adopted on June 14 and entered into force on July 5. 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 for breaches of specified obligations. The centralized procedure allows for a single application, a single evaluation and a single authorization allowing direct access to the single market of the European Union, explain Elisabethann Wright and Susan Jane Clement of international law firm Hogan & Hartson.

Article 84(1) of Regulation 726/2004 provides that each EU member state shall determine the penalties to be applied to infringement of the provisions of the Regulation. Such penalties must be effective, proportionate and dissuasive.

Penalties at EMEA request