European GDP

"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 .

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)(46 KB) responds to frequently asked questions in relation to the guidelines on Good Distribution Practice of medicinal products for human use."

Major developments

A new version of the of medicinal products was published today
The revised guidelines correct factual mistakes in subchapters 5.5 and 6.3, give more explanations on the rationale for the revision and provide a formal date of coming into operation. These guidelines, which replace the guidelines on GDP published in March 2013, are applicable as of 24 November 2013.

Responses to the public consultation on draft guidelines on the principles of good distribution practices for active substances for medicinal products for human use.

Gedeon Richter Plc., Merck KGaA, Teva Pharmaceutical Industries Ltd. and UCB Pharma SA requested that their response not be published.

It is of key importance that the quality and the integrity of the medicinal products are maintained during the entire supply chain from the manufacturer to the patient.
Today’s distribution network for medicinal products is increasingly complex and involves many players. The revised guidelines, published today, lay down appropriate tools to assist wholesale distributors in conducting their activities and to prevent falsified medicines from entering the legal supply chain.