Регуляторные исследования и экспертиза лекарственных средств (Dec 2018)

RETRACTED: International experience in drug names assessment: European Medicines Agency

  • A. N. Mironov,
  • I. V. Sakaeva,
  • V. V. Dudchenko,
  • L. V. Korneeva,
  • A. N. Yavorsky

Journal volume & issue
Vol. 0, no. 2
pp. 38 – 42

Abstract

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RETRACTED ARTICLEThe present article considers the experience of a unitary expert and control authority regulating the circulation of medicines in the European Union (EU) – the European Medicines Agency. It also describes the main contents of the current EU regulatory documentation on the newly formed drug names eligibility criteria. These criteria are directed to protect consumer's rights and allow to prevent adverse effects on human health and life caused by the marketing authorization of new drugs, which names are identical or confusingly similar with the names of previously authorized products, but different in composition and effects.

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