16 MARKETING AUTHORISATION


LSIPR Newsletter 12:14


The right to challenge


A decision by the CJEU on a Latvian case should make it easier in the future to challenge an MA granted for a generic version of a reference product, as Trevor Cook of WilmerHale explains.


S


ince the EU regime of data exclusivity for pharmaceuticals was amended in late 2005, in large part to reflect Court of Justice of the


EU (CJEU) case law in the 1990s and early 2000s, there has been little case law on the interpretation of the new legislation. Tis situation is now starting to change.


In order to secure a marketing authorisation (MA) for a new medicinal product, in addition to demonstrating satisfactory


quality, applicants must file extensive clinical and non-clinical data to support its safety and efficacy in accordance with article 8(3) (i) of Directive 2001/83/EC, as amended by Directive 2004/27/EC.


According to article 10, an application for a generic MA of a medicinal product previously authorised under article 8 can be sought eight years aſter the first MA in the EU for the active substance in the ‘reference medicinal product’, but such a generic MA cannot


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until ten years aſter the first MA for the active substance.


take effect


Tis period is extended to 11 years if the first applicant secures an MA for a new indication for the medicinal product in question during the first eight years, and the new indication is determined, during the scientific evaluation before its authorisation, to bring “a significant clinical benefit in comparison with existing therapies” (thereby giving rise to the ‘8+2+1’ characterisation of the EU data exclusivity rules).


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