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, OJ L 311, 28.11.2001, p. 67.

The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 1994: Guidelines on Good Distribution Practice of medicinal products for human use, OJ C 63(1.3.1994).

Revised guidelines were published in March 2013 in order to take into account recent advances in practices for appropriate storage and distribution of medicinal products in the European Union, as well as new requirements introduced by Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC as regards the prevention of the entry into the legal supply chain of falsified medicinal products, OJ L 174(1.7.2011).

In November 2013, has been published the most recent version of the EU Guidelines on Good Distribution Practice (GDP): This version replaces the guidelines on GDP published in March 2013.