European General Court upholds Commission decision for product recall and sales ban as a result of serious GMP shortcomings

Following the establishment of serious shortcomings to Good Manufacturing Practice (GMP), the Commission decided provisionally to suspend the sale of certain batches of medicinal products and to withdraw those batches already placed on the market. A few months later, the Commission decided to follow the European Medicines Agency's (EMA) recommendation (i) to remove the manufacturing site concerned from the marketing authorisations under Article 116 of Directive 2001/83, and (ii) to prohibit the sale of medicinal products containing the active substance manufactured at that site under Article 117(1)(e) of Directive 2001/83.

In its judgment of 7 March 2013 (Case T-539/10, Acino AG -v- Commission), the European General Court dismissed the marketing authorisation holder's action seeking to annul the Commission's decision. In doing so, the court underlined the Commission's large margin of discretion under Articles 116 and 117 of Directive 2001/83 which allows it to take action as soon as there is serious and conclusive evidence casting reasonable doubt on the qualitative and quantitative composition of the medicines in question. The court considered the established GMP shortcomings in the present case a sufficient basis for the Commission's decision: even though these shortcomings do not automatically impact on the product's composition, there is a potential risk of change of composition and therefore harm to public health which justifies regulatory action under the precautionary principle.

Please click on the links below for the other articles in the March 2013 Life sciences and regulatory newsletter

• Italian antitrust court ruling on access to data
• European Court of Justice rules on application of waste and chemicals law to duckboards in Lapland
• Actions against ECHA decisions identifying substances of very high concern under REACH found admissible but dismissed on substance
• AG confirms that the sale of medicines drawn off in different containers should be authorised
• New actions before the European courts