EEA

Legal Basis for Marketing Authorization in the EEA

Legal Basis for Marketing Authorization in the EEA

Navigating the regulatory landscape for drug approval in the European Economic Area (EEA) can be complex. There are multiple legal pathways, each with its own requirements, especially around clinical studies. Here’s a quick snapshot: Full Applications (Article 8(3) of Directive 2001/83/EC) require comprehensive clinical data for new products. Generic Applications ... Read More