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Glossary

Risk-benefit balance

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An evaluation of the positive therapeutic effects of the medicinal product in relation to the risks, i.e. any risk relating to the quality, safety or efficacy of the medicinal product as regards patients’ health or public health. 

Other glossary definitions

E

European Directorate for the Quality of Medicines (EDQM)

The quality of medicines and healthcare products in Europe is harmonized through different initiatives under…

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C

Common Technical Document (CTD)

The structure and format of applications to be submitted to regulatory authorities in the USA,…

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