Medicinal products for human use

Good Distribution Practice

Major developments

General Information

The wholesale distribution of medicinal products is an important activity in the integrated supply chain management. The quality and the integrity of medicinal products can be affected by a lack of adequate control. To this end, the Commission has published guidelines on Good Distribution Practice of medicinal products for human use in the form of a Commission guideline 2013/C 343/01.

The present guidelines are based on Articles 84 and 85b(3) of 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 2001/83/EC).

A "Question and Answer" document (version 1.0 March 2014) responds to frequently asked questions in relation to the guidelines on Good Distribution Practice of medicinal products for human use.

Additional information: