Module 1 2021

30/06/2021

Centralised Procedure; Optional Scope

 New active substances (outside mandatory scope indications) ● A new chemical, biological or radiopharmaceutical active substance as not previously authorised as a medicinal product in the European Union  Product offering significant therapeuic, scientific or technical innovation • Granting of a community authorisation is in the interests of patients at community level • Generics/Hybrid of centrally authorised products • Multiple/Duplicate • Paediatric use in accordance with paediatric regulation (EC 1901/2006)

The Organisation for Professionals in Regulatory Affairs

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Centralised Procedure steps to take

 Submission of eligibility Request ● Between 18 to 7 months before submission  Notification of intention to submit an application ● At least 7 months before submission  Appointment of Rapporteurs ● 7 months before submission  Pre-Submission Meeting

● 7 months before submission  Submission of Application  Scientific Evaluation ● 210 days of assessment (excl clock-stops)  CHMP Opinion  European Commission decision

The Organisation for Professionals in Regulatory Affairs

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