April 11, 2012
Supply of Unlicensed Medicines on Economic Grounds as Cost Containment Measure Could Not Be Justified According to EU Court of Justice
Arnold & Porter Advisory
The EU Court of Justice ruled that exemptions from the requirements for a marketing authorisation for reasons of a financial nature could not be justified. This is notwithstanding that the Polish government had argued that the importation of unauthorised medicinal products from countries other than EU Member States could be justified because they were indispensable for the survival or health of the patient as contemplated by EU pharmaceutical law.