CRED ERP 25

3. Initial Registration Strategy Applicants must choose which procedure to use for marketing authorisation applications involving one or more MSs. The MRP can be used when a medicinal product already has approved MA in at least one Member State.

The DCP should be used when no approved MA exists with intent to approve in multiple countries simultaneously.

The MRP procedure and National or Decentralised Procedure are mutually exclusive how they are used for marketing medicinal products. As an example, a product that has been approved through National Procedure in Italy can utilise the MRP procedure to gain approval in another country like Spain or France. Whereas, a medicinal product not approved can utilise the DCP procedure to be approved in Italy, Spain, and France concurrently. These processes follow clear rules and a strict timeline that is managed by the RMS and CMDh as necessary. Choosing a Registration Path Applicants must determine based on their medicinal product, marketing needs, reimbursement strategy, pricing strategy, etc., which pathway to choose.

New Medicinal Product Introduction

CP

DCP and MRP

Mandatory Scope

Optional Scope

Products from certain biotechnological processes

New active substances

Advanced Therapy

Generic medicinal products

Cancer

Informed consent applications

Neurodegenerative disorder

Bibliographic applications

Diabetes

Known substances in new combinations

Auto-immune diseases and other auto-immune dysfunctions

Existing substance with significant therapeutic, scientific or technical innovation

Viral diseases

Herbal medicinal products

Orphan Drugs

Homeopathic products

Generics/hybrids of CAPs

Consensus between the Reference Member State and Concerned Member State is the goal for completion of each procedure. Once consensus is achieved then a final assessment report is prepared by the Reference Member State. Concerned Member State(s) grant approval through their national implementation procedure, i.e., assessment of national translations of product information and mock ups.