Market entry · Cold chain

Keeping the cold chain intact from the port to the warehouse

A temperature-sensitive product can survive a well-run factory and a well-run pharmacy and still be ruined in between. The two most dangerous points are ones a manufacturer cannot see directly: the hours a consignment sits with customs, and the road transport that follows. WHO's import guidelines and the EU's Good Distribution Practice guidelines both set out what should happen at each point. This article works through what they say and what it means for choosing a partner to move temperature-sensitive stock.

What happens to a consignment at customs

WHO's guidelines on import procedures set out an eight-step sequence for implementing controls once medical products reach the border.¹ Customs authorities should routinely carry out visual examination and preliminary screening, ideally with an inspector from the national regulatory authority (NRA), checking consignment size against invoices and delivery slips and examining packaging and labelling.¹ Where samples are taken for analysis, the consignment should be quarantined at an approved site, kept away from potential contaminants, and stored under the conditions on its label or safety data sheet, including temperature, light and humidity limits, while the result is awaited; a consignment suspected of being substandard or falsified follows the same discipline while it is investigated.¹

Why storage facilities at the border matter

The guidelines are direct about why this matters for temperature-sensitive stock: many medical products degrade during storage and some need specified conditions, such as 2 to 8°C.¹ Every customs post designated to handle medical products should have secure storage facilities that include cold storage areas, with customs and NRA officials confirming that the right environmental conditions are maintained and the equipment is working and periodically inspected.¹ The guidelines also place a duty on the importer, to inform customs in advance of an anticipated arrival, so the consignment moves to designated storage without delay and, where relevant, without breaking the cold chain, and consignments requiring cold chain are named specifically as ones to prioritise for clearance, to avoid extended time in storage.¹

Once the goods are moving: whose responsibility is it

The EU's Good Distribution Practice guidelines put the obligation squarely on the wholesale distributor. Chapter 9 states that it is the distributor's responsibility to protect medicinal products against breakage, adulteration and theft, and to ensure temperature conditions are maintained within acceptable limits during transport, using a risk-based approach.² The required storage conditions, as defined by the manufacturer or on the outer packaging, must be maintained throughout transportation, and if a deviation occurs, a temperature excursion or product damage, it should be reported to the distributor and the recipient under a written procedure that already exists for investigating and handling excursions.²

Vehicles, monitoring and calibration

Vehicles and equipment must be suitable for their use and appropriately equipped, with written procedures for operation, maintenance and cleaning, and a risk assessment of delivery routes to decide where temperature controls are actually needed.² Monitoring equipment must be maintained and calibrated at regular intervals, at least once a year, and dedicated vehicles are preferred; where non-dedicated vehicles are used, procedures must protect product quality.² Deliveries must go to the address on the delivery note, into the care of the consignee, and any transit storage at a hub calls for particular attention to temperature, cleanliness and security, kept as brief as possible.² WHO's separate model guidance adds that a temperature-controlled road vehicle should hold its set range across the full annual ambient temperature on the route, including while parked with the engine stopped, with calibrated sensors at the points most likely to show an extreme and an alarm for excursions or refrigeration failure.³

Containers, packaging and cool packs

Choosing a container is a compliance decision, not a packaging detail. Selection should be based on the product's storage and transport requirements, the anticipated extremes of external temperature, the estimated maximum transport time including transit storage at customs, and the qualification and validation status of the packaging itself.² Where insulated boxes with cool packs are used, the product must not directly contact the cool pack, staff must be trained on assembling boxes for different seasonal configurations and on the safe reuse of cool packs, and frozen and chilled ice packs must be kept adequately segregated.² Some products also carry a security risk on top of a quality risk. WHO's model guidance sets out additional measures for controlled products and those of high illicit value, lockable vehicle doors and an intruder alarm, tamper-resistant seal locks, security-cleared drivers, and fully documented and tracked deliveries.³ The EU guidelines add that a distributor handling narcotics or psychotropic substances should maintain a secure supply chain with additional controls and a theft protocol.²

What this means for entering the Yemen market

None of the above is a Yemen-specific checklist, and it will not tell a manufacturer exactly which storage arrangement applies at a particular Yemeni port or how a consignment will be prioritised through customs. Those specifics are confirmed case by case with the authority. What the framework does give a manufacturer is a plain set of questions to put to any prospective distribution partner: does your customs handling keep cold chain consignments in secure, monitored storage while they clear, do your vehicles and monitoring equipment meet a calibration schedule, and do you have a written procedure for a temperature excursion. LNJC is a licensed importer and distributor of pharmaceuticals, medical supplies, laboratory equipment, pharmaceutical raw materials and packaging materials in the Republic of Yemen, based in Sana'a, and is happy to walk a manufacturer through how a specific product category is currently handled from port to warehouse.

In summary

Cold chain integrity is not decided at one point in the journey, it is decided at every point: the storage a customs post can offer while a consignment clears, the vehicle and monitoring equipment used to move it, the packaging chosen to protect it, and the written procedures that catch a deviation when one occurs. A distribution partner should be able to speak plainly to all four.

See also: how medical products are cleared for import: the controls and the paperwork.