Centralised procedure
- Published: November 29, 2019
- Last updated: November 29, 2019
The European Medicines Agency (EMA) is responsible for coordinating centralised marketing authorization applications. Once approved by the European Commission, it is valid in all EU member states as well as Iceland, Liechtenstein and Norway.
Mandatory for some medicinal products
The centralised procedure is mandatory for certain biotechnological products, orphan drugs and new active substances against cancer, AIDS, neurodegenerative diseases, diabetes, auto-immune diseases and viral diseases.
This is to ensure a high scientific level of assessment and to guarantee access to new, advanced medicines across the EU at the same time.
For other products, the centralised procedure is optional, but for some it is not possible.
Rapporteurs
The application is sent to EMA, where the Committee for Medicinal Products for Human Use (CHMP) appoints two National competent authorities (NCA) who, based on competence and national priorities have nominated interest in assessing the application and thus become Rapporteur or Co-Rapporteur.
The risk management plan is assessed by Rapporteurs from another of EMA’s scientific committees, the Pharmacovigilance Risk Assessment Committee (PRAC).
The assessment
The Rapporteur countries initially assess the application independently of each other and write separate reports. The other member states comment on the reports and they are joined together. At a CHMP meeting, all member states agree on a joint list of questions regarding uncertainties or weaknesses in the submitted documentation. The applicant then answers the questions usually within 3-6 months.
End of Procedure
As long as objections remain, new assessment rounds are started. If the applicant answers the questions satisfactorily and the benefit-risk balance is deemed to be positive, the CHMP will issue a positive opinion and forward it to the European Commission for decision.
The centralised approval applies to sales in all EU Member States as well as Iceland, Norway and Liechtenstein.
In cases where the CHMP assessment is negative, the applicant may request a re-examination or choose to withdraw its application.
More information
In Swedish: Central procedur
More information on the Centralised procedure can be found at EMA - Human regulatory:
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