EU Court: Financial Regards Not Enough to Justify Import of Unapproved Drugs

May 22, 2012
The European Court of Justice has struck down a section of a 2001 Polish law that allows doctors and hospitals to import cheaper, unapproved drugs equivalent to drugs legally authorized in the Polish marketplace. Under the law, drugs can be imported “for the purpose of saving the life or safeguarding the health of a patient” if they have the same active substance, the same dosage and exist in the same form as drugs that are authorized in Poland — and if they have a current marketing authorization from the exporting country.
International Pharmaceutical Regulatory Monitor