Directive 65/65/EEC
Directive 65/65/EEC1 was the first European pharmaceutical directive.
Intention
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.Regulation
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.Proprietary medicinal product being defined as "Any ready-prepared medicinal product placed on the market under a special name and in a special pack."