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.[citation needed] The idea behind the directive was that no medicinal product should ever again be marketed in the European Union without prior authorisation.[citation needed]
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