CRO
CP
The preferred European procedure for medicinal products to access European Union with a single market authorization
The centralised procedure is the EU regulatory pathway for the marketing authorisation of certain human and veterinary medicinal products. The centralised procedure allows for EU-wide marketing authorisation of a medicinal product, and is therefore considered to be the most efficient way to obtain EU-wide market approval.
The centralised procedure is voluntary for both EU Member States and companies, and is not applicable to all medicinal products.
The advantages of the centralised procedure include EU-wide marketing authorization of certain medicinal products, as well as a more streamlined and efficient regulatory pathway than the decentralised procedure.
The EU centralised procedure is therefore considered to be the most efficient and advantageous pathway for the authorization of medicinal products in the EU.
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.