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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.[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]

Additional recommended knowledge

See also

References

  • Maio G., On the history of the Contergan (thalidomide) catastrophe in the light of drug legislation, Dtsch Med Wochenschr. 2001 Oct 19;126(42):1183-6.
  • Shah RR., Thalidomide, drug safety and early drug regulation in the UK, Adverse Drug React Toxicol Rev. 2001 Dec;20(4):199-255.


 
This article is licensed under the GNU Free Documentation License. It uses material from the Wikipedia article "Directive_65/65/EEC1". A list of authors is available in Wikipedia.
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