Directive 2001/83/EC

Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use. The Directive dealt with the disparities between certain national provisions, in particular between provisions relating to medicinal products, which directly affected the functioning of the internal market of the European Union.

See also[]

• EudraLex
• Directive 65/65/EEC1, requires prior approval for marketing of proprietary medicinal products
• Directive 75/318/EEC
• Directive 75/319/EEC, requires marketing authorization requests to be drawn up only by qualified experts
• Directive 93/41/EEC
• Directive 2001/20/EC
• Regulation of therapeutic goods
• European Medicines Agency

References[]

• Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use [1]