Directive 65/65/EEC1

From Wikipedia, the free encyclopedia

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]}

[edit] See also

• EudraLex
• Kefauver Harris Amendment
• Regulation of therapeutic goods
• European Medicines Agency

[edit] 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.

[edit] External links

• Directive 65/65/EEC1
• New medicines legislation (overview)