Home » EU Court of Justice Confirms Access to Data in Marketing Authorization Applications
EU Court of Justice Confirms Access to Data in Marketing Authorization Applications
The Court of Justice of the European Union confirmed EMA’s right to release documents filed with marketing application for a medicinal product.
The decision stemmed from two lawsuits brought against the agency — by PTC Therapeutics and MSD Animal Health Innovation (owned by Merck) — for disclosing the contents of toxicology reports and a clinical study report the companies submitted as part of their marketing authorization applications for two products.
The EU’s highest court rejected the notion that the reports were covered by a “general presumption of confidentially.” It said the plaintiffs failed to explain how the released data would undermine their commercial interests.
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