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НАВЕРХ

To Agree Upon the Terms

05 may 2017 15:14

A board of Eurasia Economic Commission will prepare acts on issues of regulating general markets of drugs and medical devices within EEU. This work will be performed in cooperation with authorized organs of EEU member states and should be completed in 2017-2019.
It concerns the documents on the quality of drugs, growing, collection and storage of raw materials, procedures for issue of approvals for clinical trials, guidelines for selection of dose of drugs, rules for inspection for compliance with Good practice (clinical and pharmacovigilance).
To avoid confusion and to implement point 2 clause 1 of the Agreement on unified principles and rules of drug circulation in EEU it is recommended to be guided by a Glossary of Terms, uploaded to the official website of EEC and available at the following link: http://eec.eaeunion.org/ru/act/texnreg/deptexreg/LS1/Pages/pharm_glossary.aspx.
The glossary contains definitions of the following terms: drug safety (risk-benefit), bioequivalent drugs, generic drug, original drug, marketing authorization of drugs, pharmacovigilance system etc.

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