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Slovenia: JAZMP Amendment the Rules in Human Medicine

Tuesday, August 22, 2017: The Agency for Medicinal Products and Medical Devices of Slovenia (JAZMP) has inform that on 28 July 2017 the Official Gazette of the RS no. 41/2017 Rules amending the Rules on the marketing authorization for a medicinal product for human use, amending, inter alia, the content of Article 3 of the Rules of 2014.

Article 3, which defines the method of submission of the application, changes substantially so as to abandon the requirement for the parallel submission of a self-signed letter of correspondence in the event that the application is sent via the CESP's online system and is not signed with an advanced electronic signature based on a qualified digital certificate (KDP).

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