 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 the drug during pregnancy.The directive aimed at harmonising standards for the approval of medicines within the then European Economic Community

The main article 3 of the directive requires that a "Proprietary medicinal product" could not be marketed within the community without prior authorisation of the competent authority of at least one member state.