Part,  Chapter, Paragraph

1   II,     5. 15.  4|    the criteria for orphan designation in the EU and describes
2   II,     5. 15.  4|    the criteria for orphan designation and defining the concepts
3   II,     5. 15.  4|    Agency (EMEA) to review designation applications from persons
4   II,     5. 15.  4|    applications for orphan designation, for giving opinions on
5   II,     5. 15.  4| for giving opinions on the designation of orphan medicinal products,
6  III,    10.  4.  2| shared with the FVO.~ ~The designation of the competent authorities