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EU Bolar exemption is not so simple


The EU directive to introduce a US-style Bolar provision promised to harmonise the law on clinical trials. But, says Marina Barnden, inconsistent application has led to uncertainty

The EU Bolar provision was introduced by an amendment in 2004 to the Directive on the Community Code Relating to Medicinal Products for Human Use 2001/83/EC (the Medicinal Code). As patent law largely remains within the prerogative of EU member...


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