CRED ERP 25

2. Preparing for the Centralised Procedure – checklist of activities

Eligibility Is your product eligible for review under the CP? Article 3 of Regulation (EC) No 726/2004 defines the scope and eligibility of applications for evaluation under the centralised procedure through which medicinal products must ("mandatory scope") or may ("optional scope" or "Generic/Hybrid") be authorised by the Community. Mandatory for: • Medicinal Products developed by means of biotechnological processes (recombinant DNA technology, hybridoma and monoclonal antibody methods • Advanced Therapy Medicine Products (Gene Therapy, Somatic cell therapy or tissue engineered products) • Orphan products • Biosimilars which are developed by means of one of the biotechnological processes listed in the Annex to Regulation(EC) No 726/2004 • Medicinal products for the treatment of AIDS, cancer, neurodegenerative disorder, diabetes, auto-immune diseases, and other auto-immune dysfunctions and viral diseases. • Significant therapeutic, scientific or technical innovation, or where the granting of a Community Authorisation for the medicinal product is in the interests of patients at the Community level • Generics of reference products approved via Centralised procedure • In some cases generics of reference products approved via National/MRP/DCP procedures (except biosimilars) provided that the conditions, laid down in Article 3(3) of the Regulation are met (e.g. same summary of product characteristics, same name in all the Member States) • Certain paediatric use applications may be eligible, e.g., PUMAs, paediatric indication applications for applications for nationally-approved products Note: A generic or hybrid medicinal product of a reference medicinal product authorised via the centralised procedure has ‘automatic’ access to the centralised procedure under Article 3(3). Multiple/duplicate or informed consent applications from the same or different marketing authorisation holder for a specific medicinal product with an active substance(s) already authorised via the centralised procedure, have automatic access to the centralised procedure. Applications for generics/hybrids of reference products approved via the centralised procedure can also be made using the DCP/MRP procedure. Optional for: • New active substances

Further reading: https://www.ema.europa.eu/en/documents/regulatory-procedural-guideline/european- medicines-agency-pre-authorisation-procedural-advice-users-centralised-procedure_en-0.pdf

Suitability for the Centralised Procedure Is the CP the best route for your medicinal product?

Administrative • One application leads to one evaluation/one set of questions, leading to one authorisation in 27 EU Member States + 3 countries of the EFTA (Iceland, Liechtenstein, and Norway) • Transparent evaluation (assessment reports, agendas and meeting minutes) • Results in a single set of product information for healthcare professionals and patients in all the EU official languages • More efficient Europe-wide approval