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Regulation about the terms and conditions for authorization of use of medical products, designed for treatment of rare diseases was recently adopted in Bulgaria (Regulation 22/18.07.2005, SG 62/29.07.2005). This regulation enters into force on 31.12.2006 and defines the criteria, terms and conditions for definition of medical products, designed for diagnostic, prophylaxis and treatment of rare diseases. The regulation is a very important step towards providing patients with rare diseases in Bulgaria with access to the life-saving medical treatment.