EC: Guidelines of 5 November 2013 on Good Distribution Practice of medicinal products for human use

The Commission has published EU Guidelines on Good Distribution Practice (GDP) in 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. This version corrects factual mistakes identified in subchapters 5.5 and 6.3 of the revised guidelines. It also gives more explanations on the rationale for the revision as well as a date of coming into operation.