CRED SMPC 2024

23/09/2024

Regulation on advanced therapy

Dir 2001/83/EC Article 11

medicinal products

Paediatric Regulation 1901/2006

SmPC Guideline

MA Application

SmPC

EMEA Q, S&E Guidelines

“Core SmPC”

HCP’s needs

Disease concerned

QRD Templates

link_header_fp2_r2_c5

The Organisation for Professionals in Regulatory Affairs

39

● Tailored prescription ● Paediatric data ● Subpopulation data, elderly ● Benefit risk information ● Interactions

● Clear ● Concise ● Informative

● Pharmacogenetics ● Origin of product

The Organisation for Professionals in Regulatory Affairs

40

20