Medicinal products for human use

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


Period of consultation

From 15 July 2011 to 31 December 2011.

Contributions to and results of the consultation

Below are the public responses to the above-mentioned public consultation:

Objective of the consultation

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.

The consultation document

The consultation document can be downloaded here.

Protection of personal data

The policy on "protection of individuals with regard to the processing of personal data by the Community institutions" is based on Regulation (EC) N° 45/2001 of the European Parliament and of the Council of 18 December 2000. More information is available here.

Additional information: