General Information 

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 form of a Commission guideline 94/C 63/03 (94 KB)

The present guidelines are based on Articles 84 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').

 

Major developments   

03/02/2012
Responses to the public consultation on the "Revised Commission guidelines on Good Distribution Practice of Medicinal Products for human use"

The responses are published here.

15/07/2011
Public consultation of the revised Commission guidelines (177 KB)on Good Distribution Practice of Medicinal Products for Human Use

Today, DG SANCO launches a public consultation on the revised guidelines (177 KB)for good distribution practices. The content of the Guidelines on Good Distribution Practice published in 1994 is no longer adequate. It needs to be reviewed to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the European Union. Moreover, it needs to consider the new requirements for wholesale distributors and brokers established by the new Directive 2011/62/EU of the European Parliament and of the Council amending Directive 2001/83/EC on the Community code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.
Comments and suggestions are invited by 31 December 2011 and should be sent by email to:  mailto:SANCO-gmp@ec.europa.euand ADM-GMDP@ema.europa.eu