CRED ERP 25

01/07/2025

Centralised procedure (1)

• Products listed in Annex Regulation 726/2004 as mandatory for centralised procedure: • Biotech, advanced therapies, biosimilars • NCEs for HIV, cancer, neurodegenerative disorders, diabetes, autoimmune and viral diseases • Orphan drugs

(Additional information provided in the pre-read information)

The Organisation for Professionals in Regulatory Affairs

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Centralised procedure (2)

• Optional scope

• NCEs, generics/hybrids or duplicates of centralised products • Significant therapeutic, scientific or technical innovation or the interests of patients • Some paediatric use MAAs

(Additional information provided in the pre-read information)

The Organisation for Professionals in Regulatory Affairs

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