The European Regulations for Orphan Medicinal Products have been successfully implemented in the EU. Many companies have used or are using these regulations as is demonstrated by the high number of applications to the COMP. Only a limited number of products with Orphan Medicinal Product Designation have reached the market.
Hélène Sou, Anne-Virginie Eggimann
2009 – RAPS Career Book
Chapter RAPS: Working as an Independent Consultant in Regulatory Affairs
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