CRED 8 Presentations

01/07/2024

Incentives for SMEs

• Administrative and procedural assistance from EMA SME office

• Fee reductions for procedures in the pre- and post-authorisation phases, fee exemptions for certain administrative services of EMA

• Deferral of the MAA and MAA related inspection fees

• Conditional fee exemption if scientific advice is followed but MAA outcome is negative

• Assistance with translations of the Annexes to MA, including product information (EU languages only) • For micro- or small-sized enterprises, also waiver of the MedDRA licensing fee when registering with EudraVigilance

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The Organisation for Professionals in Regulatory Affairs

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 Patient involvement

The Organisation for Professionals in Regulatory Affairs 62

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