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Regulatory Affairs Department

Regulatory Department closely follows the Greek regulatory environment and ensures that the company's entire product portfolio is managed in accordance with EMEA as well as with national and local regulations.

Regulatory Department is responsible for all regulatory activities in Greece after the approval of the company's products. Marketing authorisation of most of the company's products is effected by its partners through the EMEA or MRP Procedure.

The Department cooperates closely with the Legal Department and is liaising directly with the Business Units. Additionally, Regulatory Department is in close collaboration with the International Regulatory Affairs Departments of all GENESIS Pharma's partners in order to ensure that all regulatory requirements are fulfilled and acts as a link with local regulatory authorities.

Regulatory Affairs Department is also responsible for pharmacovigilance activities, including reporting of adverse events to Greek health authorities according to local and European requirements and maintaining data bases of safety information. Furthermore, Regulatory Affairs Department is also responsible for the coordination and follow up of all regulatory activities in Cyprus.

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