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Published on 4 April 2012

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Polish unapproved drug sales ‘break EU law’

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Drugs have been sold on prescription in Poland without approval by the European Medicines Agency (EMA), it has been reported.

The European Union Courts of Justice has ruled that the Polish law, which has allowed this practice, has gone against European law.

Prescription drugs are legally only sold within the European Union if approved by either the EMA or authorities specific to the member state.

It transpires that Poland has been selling prescription drugs outside of EU law by claiming the use of a “special needs” exception. As reported in Pharma Times, products that are not approved may be warranted by a “bona fide unsolicited order”.

To meet this exception, the law states that medicines must be “formulated in accordance with the specifications of an authorised health care professional and are for use by an individual patient under his direct personal responsibility”.

Unapproved treatments containing the same active chemicals, the same dosage and form as an approved drug have been imported, if they save cost.

The element of this process that contravenes EU law is the purchasing of medicines that are not needed for medical reasons for a specific patient, the European Commission said.

European Union Courts of Justice



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