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20.03.2017
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Glossary

The original drug product means a drug product which contains a new, newly synthesized active ingredient whose efficiency and safety have been proven during pre-clinical and clinical studies.

The reproduced drug product/generic drug means a copy of the original drug product launched on the market after the patent protection period of the original drug product has expired (usually in 20 years).

The pharmaceutical substance means an active ingredient used to manufacture and make drug products and critical to their efficiency.

The international nonproprietary name of the drug product means the name recommended by the World Health Organization.

The international multi-center clinical study of the drug product means a clinical study conducted by the drug-product developer in various countries according to the same GMP (Good Manufacturing Practice) protocol; the Good Manufacturing Practice are international unified regulations for manufacturing of drug products.

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