Module 1 2021

30/06/2021

Fee reduction some examples

Examples of fee reduction (2021)

Regular fee (in Euro)

OD discount

OD + SME discount

Protocol assistance (non- paediatric-related)

44k – 89k

75%

100%

Pre-authorization inspection 22k

100% 100%

Application for a marketing authorisation

297k (single strength associated with one form and one presentation)

10%

100%

The Organisation for Professionals in Regulatory Affairs

SME=micro, small and medium enterprises Source: https://www.ema.europa.eu/en

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When to apply

At any stage of the development ….. but prior to MAA Strategic considerations • Incentives • grants, protocol assistance • Competition • literature, study registries, orphan registry • Scientific input • Stage of development • Tradename • e.g. sildenafil (Viagra / Revatio) • Review previous assessments • COMP outcome and EPARs note : more than one sponsor may obtain OD for the same indication

The Organisation for Professionals in Regulatory Affairs

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