- Directive 65/65/EEC1
Directive 65/65/EEC1 was the first European pharmaceutical directive. The directive was a reaction to the
Thalidomidetragedy 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.Fact|date=April 2007 The idea behind the directive was that no medicinal product should ever again be marketed in the European Unionwithout prior authorisation.Fact|date=April 2007
Kefauver Harris Amendment
Regulation of therapeutic goods
European Medicines Agency
* 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.
* [http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31965L0065:EN:HTML Directive 65/65/EEC1]
* [http://www.euractiv.net/en/health/new-medicines-legislation/article-117531 New medicines legislation] (overview)
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