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. 2014 Feb;3(1):1–7. doi: 10.5582/irdr.3.1

Table 2. Recent changes in fee reductions in Europe for companies developing orphan medicinal products.

Items 2013 2014
Protocol assistance and follow-up 100 for SMEs
40% for non-SMEs
(non-paediatric-related assistance)
100% for non-SMEs
(paediatric-related assistance)		 100 for SMEs
75% for non-SMEs
(non-paediatric-related assistance)
100% for non-SMEs
(paediatric-related assistance)
Pre-authorisation inspections 100% for SMEs 100%
Initial marketing authorisation application 100% for SMEs 100% for SMEs
10% for non-SMEs
Post-authorisation activities, including annual fee in the 1st year after MA 100% for SMEs 100% for SMEs