CRED ERP 25

07/07/2025

EUROPEAN COMMISSION DECISION ON THE MARKETING AUTHORISATION

EUROPEAN COMMISSION DECISION

The European Commission is the authorising body for all centrally authorised products, who takes a legally

binding decision based on EMA's recommendation.

Once granted by the European Commission, the centralised marketing authorisation is valid in all EU

Member States as well as in the European Economic Area (EEA) countries Iceland, Liechtenstein and

Norway.

Commission decisions are published in the Community Register of medicinal products for human use. EMA

publishes a European public assessment report (EPAR) for each medicine.

When a new marketing authorisation application is refused, EMA publishes a refusal EPAR, including a

question and answer document and an assessment report.

When: Within 67 days of receipt of CHMP opinion[1]

The Organisation for Professionals in Regulatory Affairs

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NEW MARKETING AUTHORIZATION

The centralised procedure (CP) makes provision for submission of a single new marketing authorisation application (MAA) to the EMA with scientific assessment being conducted by a rapporteur/co-rapporteur, and assessment of the risk management plan by the Pharmacovigilance Risk Assessment Committee (PRAC). Scientific discussion and final opinion are carried out by the Committee for Human Medicinal Products (CHMP), resulting in one EU marketing authorisation (MA) for the EU issued by the European Commission (EC) [2].

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