Module 1 2021

28/06/2021

SME = micro, small and medium- sized enterprises

EMA implementation Commission Regulation 2049/2005 • adopted 15 Dec 2005 • In order to reduce the costs for SMEs of marketing medicinal products authorised via the centralised procedure, that Regulation therefore foresees the adoption of specific provisions allowing a reduction of fees, deferring the payment of fees, and providing administrative assistance.

Scope • SME as defined in 2003/361/EC • Covers human and veterinary medicinal products

The Organisation for Professionals in Regulatory Affairs

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EMA SME office

SME office at EMA • Dedicated to addressing the particular needs of smaller companies • Advice to applicants

• Companies having EMA-SME number appear in SME register • Up to 90% (non-orphan)/100% (orphan) fee reduction Scientific advice

• Training and workshops - User guide for micro, small and medium-sized enterprises • Partnering and networking • Newsletter

The Organisation for Professionals in Regulatory Affairs

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