“How to Get Marketing Authorization in Europe”
In this article, you are going to learn about the marketing authorization process in the EU region.
European Medicines Agency (EMA) is the key regulator for regulating and monitoring medicinal products in the European Union. It has some expert committees which provide opinions on the quality, safety, and efficacy of the medicines mainly CHMP (Committee for Human Medicinal Products)
Marketing Authorization Procedures
The following marketing authorization procedures are there in the EU these include
- Centralized Procedure
- Decentralized Procedure
- National Procedure
- Mutual recognition Procedures
- Centralized Procedure: This Procedure is used for biological products or products for cancer, diabetes etc., using this procedure a company can submit single application to European medicines agency for marketing authorization that is valid throughout the EU member states. if there is a positive outcome, it is very beneficial to the sponsor as single application is sufficient to get MAA in all the EU member states.
- Decentralized Procedure: This procedure is used for getting simultaneous authorization in more than one member state of EU. This procedure is used for products that fall outside the scope of centralized procedure. here the sponsor can select countries to apply for MAA , this procedure is used for products that are not yet authorized in any EU member countries.
- National Procedure: This is used for products that fall outside the scope of centralized procedure . here applications can be submitted to each country, as each country has its own national procedure.
- separate application is required for each country
- if application is rejected in one country, it does not impact to application applied for other countries as each application is prepared according to countries own national procedure.
- Mutual Recognition Procedure: In MRP one country reviews the application and other countries accept the decision. Applicant submit one application to the member country for products that fall outside the scope of centralized procedure. here also negative outcome impact numerous countries in this form of MAA.