The EU Commission has launched a consultation on the 141/2000 EU Regulation of orphan medical products.
The purpose of this consultation is to collect views, relevant evidence and information from stakeholders to provide the European Commission with material for further developing the EU legislation on orphan medicinal products.
The views of the rare disease community are being sought on 5 questions, including the definition of the term "significant benefit" and clarification on processing the transfer of orphan designations between sponsors.
If you would like to comment please go to the Consultation Document. The deadline is 15 February 2016.