Module 1 2021

30/06/2021

Centralised Procedure

 EU Marketing Authorisation through Centralised Procedure ● 1 marketing authorisation; ● 1 (invented) name ● 1 common product information  Dossier submission to EMA ● Initial Assessment by Rapporteur and Co-Rapporteur ● Discussion in the CHMP ● Scientific Opinion by CHMP; Positive opinion by absolute majority of votes ● Final Approval given as Decision by the European Commission

The Organisation for Professionals in Regulatory Affairs

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 Biopharmaceuticals • Recombinant DNA Technology • Controlled expression of genes encoding for biologically active proteins • Hybridoma and monoclonal antibodies cells • Biosimilars;  Advanced therapy Medicinal Products (ATMPs) ● Gene Therapy medicinal products; ● Somatic Cell therapy medicinal products ● Tissue engineered products  Certain therapeutics areas ● AIDS, Cancer, Neurodegenerative disorders, Diabetes, Autoimmune diseases, Viral Diseases  Orphan medicinal products Centralised Procedure;Mandatory Scope

The Organisation for Professionals in Regulatory Affairs

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10