To obtain market authorization for a medicinal product in the European Union (EU), a manufacturer can opt one of the four registration pathways, such as:
- Centralized Procedure
- National Procedure
- Mutual Recognition Procedure
- Decentralized Procedure
As specified by the European Medicines Agency (EMA), the procedures are based on the type of the product and the number of countries in which the medicine is intended to be marketed.
Centralized Procedure (CP)
The centralized procedure allows manufacturers to submit a single Market Authorization Application (MAA) to the EMA. The CP is useful for manufacturers who are planning to market products in the European Economic Area (EEA) countries Iceland, Liechtenstein and Norway as well as in the EU. The centralized procedure falls under the Regulation (EC) 726/2004 and allows the manufacturers to market the products to the healthcare professional post the approval by the European Commission (EC).
National Procedure (NP)
Medicines which are outside the scope of the centralized procedure or which were authorized before the creation of the EMA fall under the authorization of the national procedure (NP). It is useful for manufacturers who aim to obtain market authorization in specific EU member states. In this procedure, applications are reviewed by the competent authorities of the respective EU member state. Each EU member state has a national procedure of its own.
Mutual Recognition Procedure (MRP)
In Mutual Recognition Procedure (MRP), market authorization granted in one EU member state is recognized in other EU member states. MRP is applicable only when the manufacturer has already obtained market authorization in one of the EU countries. The regulations for market authorization through MRP are established in the Directive 2001/83/EC. If an application for MRP is submitted to more than one EU country, it must be ensured that all the applications are identical. The country evaluating the application is called as the Reference Member State and is responsible for notifying the other concerned Member States regarding the status of the application.
Decentralized Procedure (DP)
Decentralized procedure (DP) is applicable for medicines which have not yet been authorized in the EU. For these medicines, manufacturers can apply for simultaneous authorization in several EU member states. The procedure falls under the Directive 2004/27/EC. In the DP, any one-member state can take the initiative of evaluating the application.
While all the procedures would lead to obtaining compliance, choosing the best procedure for your scenario will be challenging. For any assistance on opting the best Registration pathway reach out to Freyr @ sales@freyrsolutions.com.
The European Medicine Regulatory Network comprises different authorization pathways. Know more about the market entry in Europe from our focused podcast sessions