Regulation (EC) No. 141/2000 1 of the European Parliament and of the Council on Orphan Medicinal Products was drafted on December 16, 1999 and formally adopted by the European Commission on April 27, 2000. This regulation established a Community procedure for designating orphan medicinal products and introduced incentives for the research,development and marketing of orphan medicinal products in the European Union (EU).
Emmanuelle Voisin
2004 – RAPS Book Chapter
RAPS Orphan Medicinal Products Regulation in Europe
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Emmanuelle M. Voisin, PhD
Founder and CEO
Dr. Emmanuelle Voisin founded Voisin Consulting Life Sciences (VCLS) in 1997. The firm has become a leading advisor to Biotech,…
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