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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
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January 29, 2020
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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