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Unified EEU Pharmaceutical Market is Launched

03 may 2017 12:25

Main regulatory acts of EEU, providing functioning in the Union of general markets of drugs and medical devices are entering into force on May 6, 2017. The acts relate to the rules of regulation, good practices (GxP), requirements to prescribing information and labeling, good practices of studies of biological drugs and other regulations approved by the EEU Council.
Six resolutions of the EEC Board have come into effect, approving the Nomenclature of pharmaceutical forms, Rules of Nomenclature Maintenance for Medical Devices, Rules of defining categories of OTC and Rx drugs, Rules for safety, quality and efficacy Процедура контроля за ходом доклинического (неклинического) исследования и обеспечением его проведения, сбора данных и представления результатов исследования согласно протоколу, стандартным операционным процедурам и настоящему стандарту.monitoring of medical devices.
According to the Parliamentskaya Gazeta of May 1, 2017 medical drugs, with information included into the unified register of marketed drugs in EEU, are not considered to be excisable goods, which will enable to reduce the prices.

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