BethAri Limited

Innovative Solutions, Delivered.

New EU guideline on Good Distribution Practice published - 05 Sep 2012

Good Manufacturing Practices (GMP) and Good Distribution Practices (GDP) are, within the pharmaceutical industry, interlinked. The Guidelines laid down in Article 84 of Directive 2001/83/EG on Good Distribution Practice (Document 94/C 63/03) has remained unchanged since it was published in the Official Journal of the EU in 1994. However, there has been several advances in pharmaceutical product integrity throughout the supply chain, as evident by recent reviews and publications e.g. Directive 2011/62/EU on Falsified Medicines ( which is intended to provide Guidelines on Good Distribution Practice), USP Chapter <1083> Good Distribution Practices - Supply Chain Integrity, necessitating a revision of the 1994 Guidelines.

The guideline was revised to take into account advancements of practices for an appropriate storage and distribution network of medicinal products in the European Union. The revised guideline on Good Distribution Practice, published by the EU Commission, for public consultation is much more extensive. A detailed requirement and list of obligations for both medicines wholesalers and brokers is presented in 10 chapters within this draft guideline. A copy can be downloaded here.

< Back to News page