CRED 8 Presentations

01/07/2024

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)

The Organisation for Professionals in Regulatory Affairs

11

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

12