The process for obtaining a MA is very complex and highly regulated.
A medicine may only be placed on the market of a Member State of the EU or the European Economic Area (EEA) when a marketing authorisation (MA) has been issued by the national competent authority of that member state (MS) or by the European Commission after scientific assessment by the European Medicines Agency (EMA).
Legal basis: Article 6, Directive 2001/83/EC
The map below (Figure 3) shows the geographic area covered by the EU member states and the three EEA EFTA states Liechtenstein, Norway, Iceland.
Figure 3: geographic area covered by the EU member states, including the three EEA EFTA states Liechtenstein, Norway, Island
The European Economic Area (EEA) unites the EU member states and the three EEA EFTA (the European Free Trade Association) states Iceland, Liechtenstein, and Norway into an Internal Market governed by the same basic rules. These rules aim to enable goods, services, capital, and persons to move freely about the EEA in an open and competitive environment, a concept referred to as the four freedoms.
The main principle underlying the pharmaceutical legislation is the protection of public health.
MAs for medicines are dynamic and not static and the dossier underlying an MA must be regularly updated in order to ensure that scientific progress and new regulatory requirements are incorporated.
Any new information which may influence the evaluation of the benefits and the risks of the medicine must be promptly communicated to the competent authority.
With the content of the application dossier the applicant has to demonstrate that the medicine has the required quality and that it is safe and efficacious.