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Regulatory affairs

The Direction of Regulatory Affairs of Italfarmaco SpA is engaged in the direct management of activities aimed at obtaining and holding Marketing Authorizations in the countries of the European Community, in Russia, Turkey, Kazakhstan, Uzbekistan, Kyrgyzstan, Azerbaijan, Vietnam, China, Korea and other countries by means of its Group companies.

Globally, Italfarmaco Group holds marketing authorizations in no less than 57 countries.

The Direction has qualified skills for the management of regulatory processes of the European Union through community procedures both decentralized and centralized. This know how has enabled to obtain the marketing authorization for new medicinal products and innovative technologies of drugs of known efficacy in the countries of both the European Union and the rest of the world.

The regulatory area also includes skills related to Food supplements and Medical Devices.