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What deadlines are stipulated by the amended Act on Pharmaceuticals for supplementing of information by the applicant where applications for marketing authorisation, applications for renewal of a marketing authorisation and type II variation applications

Pursuant to Section 31 paragraph 5 (c) of the amended Act on Pharmaceuticals, the deadlines for supplementing of applications for marketing authorisation following the national procedure, applications for renewal of marketing authorisation and application for type II variations following the national procedure submitted after 2 April 2013 shall be stipulated by the Institute and shall be adequate to the given circumstances (scope of the required supplementation).