Centralized Procedure

The preferred European procedure for medicinal products to access European Union with a single market authorization


What to know about European Centralized Procedure ? 

The centralized procedure is mandatory for certain human medicinal products such as those developed by certain biotechnological processes, ATMP, designated orphans, and products containing new active substances for several treatments targeting diseases such as : acquired immune deficiency syndrome, cancer, neurodegenerative disorders, diabetes, auto-immune diseases, other immune dysfunctions and viral diseases.


The CP may also be used on a voluntary basis for other medicinal products containing a new active substance, or medicinal products which constitute a significant therapeutic, scientific or technical innovation or that the granting of an EU marketing authorization would be in the interests of patients at EU level.