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Centralized procedure

Centralised authorisation procedure of medicinal products

 

Medicinal products subjected to the centralised authorisation procedure in accordance with the European Union legal acts [Regulation (EC) No 726/2004 of the European Parliament and of the Council (31 March 2004)]: medicinal products manufactured utilising biotechnological processes, orphan medicinal products containing new active substances and intended for treatment of diseases such as acquired immunodeficiency syndrome, diabetes mellitus, cancer, etc., as well as other medicinal products. Marketing authorisation is performed by the European Medicines Agency (EMA). The decision regarding marketing authorisation is adopted by the European Commission (EC) and it is binding to all EU member states. Prior to distribution of a medicinal product in any member state, the marketing authorisation holder must inform the relevant national medicines agency.

Please see more information on the website of the European Medicines Agency

 

Submission of documents

In 2014, EMA introduced a system for circulation of documents – the Common Repository. SAM uses this system to obtain information regarding all applications for the centralised authorisation procedure. This system allows searching, overviewing and downloading all of the applications in an eCTD (electronic Common Technical Document) format submitted to EMA for marketing authorisation of medicinal products via the centralised authorisation procedure using the eSubmission Gateway/Web Client system.

The application is available in the Common Repository, therefore, it is not necessary to submit to SAM additional copies of the application in a CD/DVD format or using the Common European Submission Platform for marketing authorisation applications.