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Institute for rare diseases » Orphan Drugs
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  • Orphan Drugs

    Print | Wednesday 21 December 2011 | 15,520 views

    You can find in this section information about the registered and marketed orphan drugs in the EU, as well as their current status in Bulgaria.

    According to the European definition, orphan drug is a medicinal product which:
    – is intended to diagnose, prevent or treat life-threatening or progressive chronic diseases that affect not more than 5 per 10 000 people throughout the country;
    – is intended to diagnose, prevent or treat life-threatening diseases and seriously impairing chronic health conditions (diseases causing high incapacity and disability) and are attached evidence that the sale of the product does not provide a satisfactory return to justify necessary investment in research and development, without incentives for the originator of the product;
    – when there is no satisfactory method of diagnosis, prevention or treatment of the condition, or if there is such a method, the proposed product has significantly more advantages than it and benefit to those affected by this condition.

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