European Registration Procedures

Centralized Procedure

The EMA serves as the governing authority for the centralized procedure. The European Medicines Agency (EMA) Committee for Medicinal Products is responsible for issuing a single license that is valid in all member states of the European Union. This committee has representatives from each of the EU’s member states. Certain categories of medications, such as those used to treat HIV/AIDS, oncology, diabetes, neurodegenerative disorders, autoimmune disease, and viral diseases, are required to go through this method of gaining regulatory approval.

The National Procedure

When it comes to the approval of drugs that don’t have to go through the centralized process, individual EU states are free to develop their own systems and protocols.

Mutual Recognition Procedure

It is possible for drugs that have been given marketing authorization in one member state of the EU to get that same authorization in another member state of the EU.

Decentralized Procedure

When it comes to products that have not yet been authorized in any EU state and that do not fall under the mandatory centralized process, manufacturers have the ability to submit applications for simultaneous approval in more than one EU state. 

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