ECJ tells Poland to tighten up controls on medicine authorisation
Says country has breached EU medicinal products directive 2001/83
The European Court of Justice has told the Polish government to stop allowing sales of imported medicines that are similar to those approved within Poland, but cheaper. Polish law allows sales of foreign medicines with the same active substances, dosage and form as medicines carrying marketing authorisation in Poland, if the imported drugs’ price is ‘competitive’.
The ECJ has ruled that this breaches EU medicinal products directive 2001/83, which says explicit authorisation must be secured by national regulators of the European Medicines Agency for all EU medicine sales.
Judges rejected Polish arguments that the loophole was justified by a ‘special needs’ provision in the directive allowing doctors to prescribe special medicine to individuals. This could only follow an ‘actual examination of…patients…[though] purely therapeutic considerations,’ the court said.