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DIRECTIVES (European)
Eudralex - Volume 1
Pharmaceutical Legislation: Medicinal Products for Human Use
Directives & legislation
European search engine
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.
Directive 2004/27/EC
of the European Parliament and of the Council of 31 March 2004 amending Directive 2001/83/EC on the Community code relating to Medicinal Products for Human Use.
Directive 2008/29/EC
of the European Parliament and of the Council of 11 March 2008 amending Directive 2001/83/EC on the Community code relating to Medicinal Products for Human Use, as regards the implementing powers conferred on the Commission.
DIRECTIVES (USA)
21 CFR Parts 210 and 211
Current Good manufacturing Practice in Manufacturing, Processing, Packaging or Holding of Drugs; General and Current Good Manufacturing Practice for Finished Pharmaceuticals
21CFR Part 820
Quality System Regulation
ICH
ICH Website
Provides links to the ICH Guidelines
