Market authorisation: ECJ finds against Poland

摘要

Polish legislation authorising the placing on the market of foreign medicinal products lacking authorisation, which are cheaper than, but similar to, those already authorised is contrary to EU law, said the EU Court of Justice, on 29 March~1.In answer to an action for failure to fulfil obligations brought to the ECJ by the European Commission, the judges ruled that this practice was in breach of Directive 2001/83/EC on the Community code relating to medicinal products for human use, and could in no way be considered an acceptable derogation.