Directive 65/65/EEC1

Directive 65/65/EEC1 was the first European pharmaceutical directive. The directive was a reaction to the Thalidomide tragedy in the early 1960s, when thousands of babies were born with deformities as a result of their mothers taking thalidomide during pregnancy. The directive aimed to establish and maintain a high level of protection for public health in Europe. The idea behind the directive was that no medicinal product should ever again be marketed in the European Union without prior authorisation.