Eu legislation


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EU legislation

  • Generic medicinal product shall mean a medicinal product which has the same qualitative and quantitative composition in active substances and the same pharmaceutical form as the reference medicinal product, and whose bioequivalence with the reference medicinal product has been demonstrated by appropriate bioavailability studies. The different salts, esters, ethers, isomers, mixtures of isomers, complexes of derivatives of an active substance shall be considered to be the same active substance, unless they differ significantly in properties with regard to safety and/or efficacy....“



Innovative drugs and generics – complementary from customer’s perspective



Strategic Customer Values







The environment: A



The environment: B



The environment: C

  • Increasing life expectancy – not least an outcome of modern, high effective drugs – results in severe challenges for healthcare systems. The generation 65+ represents 14% of the population, with a drug consumption of approx. 30-40%

  • EU population will decrease from 376mio (2000) to 364mio (2050)

  • Share of working population (15-64) will decrease by 20%

  • Generation 65+ will increase from 61 Mio to 103 Mio



Leading causes of death, SR 2002



Top 10 molecules in terms of savings



Impact of generic market entries







Slovakia: Five of the top 20 are generic companies



Development of market shares (value)



Status quo of Generics in Slovakia



Status quo of Generics in Slovakia





  • Christian Wieser General Manager Sandoz Slovakia

  • Prezident asociácie Genas

  • Ruzinovska 42 82103 Bratislava

  • Phone: +421.2.48200.600

  • Email: christian.wieser@sandoz.com Web: www.sandoz.sk www.genas.sk





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