EMA: Regulatory and procedural guideline: Concept paper on Storage Conditions during Transport, draft.

The globalisation of the manufacture of human and veterinary medicinal products has brought both benefits and a wide range of challenges. This paper is concerned with challenges related to the maintenance of appropriate transit conditions during transport as products move through all stages of the manufacturing and wholesale distribution system from active substance through the wholesale distribution system to ensure that patients and animals receive safe and efficacious medicinal products. The current guidance (CPMP/QWP/609/96/Rev2) was written in 1996 and revised in 2003, during this time significant changes continued to occur in the globalisation of manufacture with a consequent increase in the complexity and vulnerability in the supply chain.