GDP and transport: what the European guidelines ask of medicine transport

The GDP guidelines apply to wholesalers of medicinal products for human use. The European medicines directive obliges holders of a wholesale distribution authorisation to comply with the GDP principles and guidelines; in the Netherlands the Medicines Act does so through Article 36, and the accompanying regulation designates the European guidelines. Wholesale distribution without an authorisation is prohibited; supervision lies with the IGJ. According to the EMA the guidelines describe the minimum requirements for a wholesaler, including the correct storage conditions during transport.

Pharmacies do not fall under GDP but under their own professional standards, and medical devices fall under the regulations on devices and in-vitro diagnostics, not under GDP. A carrier is not an addressee in its own right; how GDP reaches it nonetheless is explained below. What GDP is in plain language, with the ten chapters and what it is not, is in what is GDP; how medicines move through the chain in medicine transport.

Chapter 9 starts with responsibility: the supplying wholesaler protects medicines during transport against breakage, falsification and theft and keeps the temperature within acceptable limits, on the basis of a risk assessment. Storage conditions during transport stay within the limits described by the manufacturer or shown on the outer packaging. Deviations are reported to the distributor and the recipient and investigated. A risk assessment of the route determines where temperature control is needed; measuring equipment is calibrated at least once a year; delivery takes place at the address on the delivery note, to the addressee.

For equipment, the chapter asks for packaging and containers suited to the product, the volume, the expected outside temperature and the duration of the ride; for temperature-sensitive products qualified equipment such as thermal packaging or conditioned containers; cooling elements that do not come into direct contact with the product; staff trained in assembling insulated boxes per season; and temperature information for the customer on request. The guidelines give no figures anywhere: 2-8 °C or 15-25 °C are not in the text, but on the product's pack.

When transport is outsourced, chapter 7 applies. There is a written contract with a clear division of tasks; the client remains responsible, may audit before the start and at any later moment, and the contractor may not subcontract anything without approval and audit. The wholesaler informs the carrier of the transport conditions, and the contract includes the requirements of chapter 7.

The IGJ has clarified the carrier's position: a company that only transports medicines and holds them at a location for less than 72 hours needs no wholesale distribution authorisation; one that structurally stores them for 72 hours or longer does. In both cases the GDP rules on personnel, storage and transport must be observed, under the client's supervision. The wholesaler cannot transfer the responsibility for transport by contract. Who then remains responsible for what, and what belongs in the contract, is explained in GDP responsibilities in outsourced transport. What that means for the often-heard claim 'GDP-certified' is explained in GDP training or GDP certificate.

The limit for transport is the product's storage condition. It appears in standardised statements on the pack, such as 'Do not store above 25 °C' or 'Store in a refrigerator (2 °C - 8 °C)', and follows from the stability data; terms such as room temperature are not allowed on a label. Without a storage condition, the European inspectors say temperature must still be controlled and monitored; the IGJ then assumes 15-25 °C and applies lower limits for short transports of 2 °C and, for products that do not belong in a refrigerator, 9 °C. That is supervisory policy, not statute.

What the conditions mean in practice and how the cold chain works is explained in temperature-controlled transport; what should happen in the event of an excursion in temperature excursion during transport. How UrgentX has built its way of working around the transport parts of chapter 9, without claiming a certificate a carrier cannot obtain, is described under transporting medicines in line with GDP.