ECJ TELLS POLAND TO TIGHTEN UP CONTROLS ON MEDICINE AUTHORISATION
April 1st, 2012
BY KEITH NUTHALL
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 this breaches EU medicinal products directive 2001/83 which says explicit authorisation must be secured by national regulators of the European Medicines ...
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