Poland faces ECJ action over pharmaceutical controls
EC claims Poland is breaking key market approval controls
The European Commission (EC) is planning to take the Polish government to the European Court of Justice (ECJ), claiming it is breaking key European Union (EU) pharmaceutical market approval controls.
The EC is not pleased that Poland allows non-authorised medicinal products to be sold that are similar to an approved product, just because they are cheaper. The EC says these medicines should receive full safety assessments given to completely novel products.
‘Such provision, which is purely based on financial considerations, is not covered by the targeted exemptions foreseen by EU law and therefore infringes it,’ said the EC.
If the ECJ rules against Poland and the Polish government ignored its rulings, then its judges could impose heavy daily recurring fines, payable until Poland reforms its regulations.