CRED ERP 25

01/07/2025

Non-centralised procedure options

• MRP, DCP or Nationalised Procedure • Known active substance • Herbals • Homeopathic products • Generics of nationally or MRP or DCP approved products • It can be argued that the product is eligible for the use of the centralized procedure.

(https://www.ema.europa.eu/en/documents/regulatory-procedural guideline/european-medicines-agency-procedural-advice-users centralised-procedure-generic/hybrid-applications_en.pdf)

(Additional information provided in the pre-read information)

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Disease and target population

• Unmet medical need vs. “me too”

• Blockbuster vs. niche product

• Well-known vs. new/complex area

Divergent medical practices

•

• Cultural/sociological considerations.

The Organisation for Professionals in Regulatory Affairs

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