24 October 2013,
Updated 24 October 2013
A transportation provider that only transports medicinal products does not need an authorisation for wholesale distribution of medicinal products (a section 39 authorisation).
Nor is a section 39 authorisation required if the medicinal products are not transported directly from A to B, but are carried e.g. via a transportation hub and stored for a short period (for example during the weekend). Any unpacking or repacking of the medicinal product during transportation must not take place.
It is the responsibility of the supplying wholesale distributor to ensure that the medicinal products are transported in compliance with the Good Distribution Practice (GDP) principles. Thus, the supplying wholesale distributor must ensure that the medicinal products are protected against breakage, adulteration and theft, and that temperature conditions are maintained within acceptable limits during transport. The supplying wholesale distributor must therefore ensure that own transportation and/or the transportation provider used comply with this practice.
The requirements applying to transportation are described in guidelines on good distribution practice of medicinal products for human use, chapter 9.
This is the previous practice that will also be followed in future following implementation of the new EU guidelines on good distribution practice of medicinal products for human use.