Pharma companies can challenge approvals of generics based on their medicines

Published: 19-Nov-2014

According to a ruling by the European Court of Justice


The European Court of Justice (ECJ) has ruled that European Union (EU) pharma companies can legally challenge market authorisations secured by a generic manufacturer for medicines based on a reference product made by the original manufacturer.

The case has come to light in a dispute between Latvian pharma manufacturer Olainfarm and the Latvian health ministry and medicine products agency, Zāļu valsts aģentūra.

Olainfarm wanted to block the award of a market approval to Latvian generic manufacturer Grindeks, based on its medicine Neiromidin. This right was challenged in the Latvian courts and the ECJ was asked for an advisory ruling.

The European court has largely supported Olainfarm, saying that it has this right of challenge under EU directive 2001/83, as amended by EU regulation no 1394/2007.

Olainfarm ‘has the right to a judicial remedy enabling him to challenge the decision of the competent authority which granted the marketing authorisation for the generic product…,’ said the ruling.

ECJ cases set legal precedents across the EU.

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