EC Draft Guidance On Distribution Practices

A public consultation has opened in Europe for the revised guideline on the good distribution practice of medicinal products for human use. The consultation was launched by the EC’s Directorate General for Health and Consumer Policy and, according to a statement from the EMA, will be of particular interest to wholesale distributors and brokers of medicinal products for human use, as well as for manufacturers that distribute their own products. The original guideline was introduced in 1994.

“The content of the Guidelines on Good Distribution Practice published in 1994 is no longer adequate,” stated the draft guideline. “It needs to be reviewed to take into account advancements of practices for an appropriate storage and distribution of medicinal products in the EU.”

In particular, the guideline takes into account the new requirements for wholesale distributors and brokers established in Directive 2011/62/EU, which concerns falsified medicines—and was discussed in a previous PharmTech news piece. A number of points in the revised guidance relate to falsified medicines; for example, the guideline states that training programmes should include aspects on identifying and preventing falsified medicines from entering the supply chain, and procedure should be in place for segregating and reporting suspected falsified medicines.

“Today’s distribution network for medicinal products is increasingly complex and involves many players,” stated the introduction to the draft guideline. “The quality and integrity of medicinal products can be affected by a lack of adequate control over the numerous activities, which occur during distribution and it is also necessary to address the threat that falsified medicinal products pose to the distribution channel.”

The guideline aims to exercise greater control over the entire distribution chain, which includes all activities consisting of procuring, holding, supplying or exporting medicinal products (with the exception of supplying them to the public). It will ensure that products manufactured in or exported into the EU are of a satisfactory quality level.

The deadline for comments is 31 December 2011. The guidance is expected to come into operation approximately 6 months after publication.