This document is the COMMISSION REGULATION (EC) No 847/2000
of 27 April 2000
laying down the provisions for implementation of the criteria for designation of a medicinal
product as an orphan medicinal product and definitions of the concepts ‘similar medicinal product’
and‘clinical superiority’
Orphan medicines
This docment is the Regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999 on orphan medicinal products
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Ethic’s Committees assessment of protocols for trials with orphan medications
Published by IRDiRC
Ethic and Legal Issue GuidelineEthical AssessmentOrphan DrugProtocol AssessmentRegulatory SciencesEthical assessment of clinical trials in orphan diseases should be done by experienced committees, and should ensure that all relevant aspects of this particular type of trials is properly assessed.
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