Stakeholders are invited to comment on the following items which are included in the draft Notice which includes the following:
• Clarification of the definition of “significant benefit”
• Encouraging the development of orphan medicinal products for communicable diseases (e.g. Ebola)
• Simplifying the procedure for the reassessment of orphan criteria when two authorisation application procedures are pending in parallel for two orphan medicinal products.
• Introducing the reassessment of the orphan criteria for a new subset of the condition when a sponsor extends the use of its product after marketing authorisation
• Clarifications on processing the transfer of orphan designations between sponsors.
This notice is open for public consultation from 16 November 2015 to 15 February. The EC asks interested parties to submit responses to these public consultations by 15 February 2016 at the latest by e-mail to SANTE-PHARMACEUTICALS-D5@ec.europa.eu.