Transportation of pharmaceutical products is a task that requires maximum caution, strict adherence to transportation rules and current legislation. Failure to comply with the relevant regulations during transportation can lead to spoilage of products and harm the health of consumers.
Ukraine has developed a regulatory framework governing the rules for the import of pharmaceuticals and their customs clearance. In accordance with article 17 of the Law “On Medicinal Products”, medicines that are registered here and have the appropriate quality certificate issued by the manufacturer can be imported into Ukraine. Control over the import of pharmaceutical products is carried out by the State Inspectorate for Quality Control of Medicines.
Unregistered medicines can be imported into Ukraine in several cases:
- for the registration itself (corresponding samples are imported);
- for clinical trials;
- to participate in exhibitions or conferences;
- for personal needs of citizens.
Detailed rules for importing goods in these cases are regulated by the Ministry of Health of Ukraine.
Rules for the transportation of medicines in Ukraine
To implement the provisions of the mentioned law, the Ministry of Health adopted an order “On approval of the rules for the transportation of medicines”. All rules are focused on the mandatory provision of appropriate transportation conditions to maintain the integrity and quality of products during the delivery of goods with pharmaceutical products. First of all, you need to pay attention to the information from the packaging of the medicinal product or the instructions for use, where the need for special conditions during transportation is noted.
Medicines must be transported in packages. Pharmaceutical products must not be transported together with food products and must be protected from damage to the packaging. If the product requires special attention in transport, it is necessary to mark with the designation “Caution!”, “Keep away from heat”, “Glass”, “Afraid of the cold”, “Fragile”, “Top”.
Pharmaceutical products must be protected from direct light, excess moisture, dirt and too high or low air temperatures. If pharmaceutical products are transported in ampoules or vials, corrugated cardboard or bubble wrap must be used to ensure product integrity.
Requirements for vehicles for the transportation of medicines
There are also a number of requirements for the transport of pharmaceutical products. The vehicle must be in good technical condition, equipped with fire fighting equipment and everything necessary for cleaning equipment, have a sanitary passport.
If medicines require a special storage temperature, they can only be transported in specially equipped vehicles. This refers to the presence of refrigeration units with thermometers or thermal containers. Regular monitoring of temperature and moisture should occur. The temperature regime must be observed at all stages of cargo delivery: when receiving goods, transshipment from one transport to another, during unloading at the time of receipt. Overheating or hypothermia of pharmaceutical products can lead to the loss of medicinal properties, which is harmful to the health of consumers.
Psychotropic and potent drugs are classified as dangerous goods, so they are transported in sealed refrigerators often accompanied by an authorized person.
Also, transport must have special cargo containers and pallets that can be cleaned regularly using disinfectants. Each time after transporting drugs, the vehicle interior must be properly cleaned. It is strictly forbidden to store foreign objects that may contaminate the packaging of drugs.
Medicines that are imported through the customs border of Ukraine require mandatory declaration. Only after the submission of the declaration can the customs control and clearance process be carried out. Together with the declaration, the availability of medicines is checked by the customs inspector. When importing pharmaceutical products, the cargo customs declaration indicates all the necessary data about the medicine: series, full name, details of the quality certificate, scope, active substance, type of primary packaging, and the like.
US Pharmaceutical Quality Control
In the United States, quality control of pharmaceutical products is carried out by the Food and Drug Administration (FDA). It is this organization, in accordance with applicable law, that approves all commercial imports of pharmaceutical products. Therefore, if importers, for example, want to deliver cargo by air, they must consult with the FDA to ensure that pharmaceutical products comply with established standards. All imported drugs must be in the original packaging. Also, U.S. Customs legislation requires that each product manufactured abroad be labeled in English with the name of the country of origin. Markings must be legible and visible.
Methods of transporting pharmaceutical products from the USA
Delivery of products from the United States is carried out in two ways – by sea and by air. The choice of transport for delivery depends on the time of transportation and the specific conditions of transportation. When delivering goods with medicines, the main criterion for transportation is reliability and maximum preservation of the quality of the cargo.
The sea route is economically viable. Using road or rail transport, appropriately packaged pharmaceutical products are delivered to the port. Already at the port, the cargo passes the necessary clearance. After shipping, the goods are delivered to the final destination by land or air. Delivery time using sea delivery takes 5-6 weeks. On the coast of the Pacific and Atlantic oceans in the USA there are 315 ports (19 of them are considered international). The largest are the port of Los Angeles, the port of New York, Long Beach.
Pharmaceutical products can be delivered as quickly as possible thanks to air delivery, which on average takes 10-14 days. From the USA, air cargo can be sent from several hundred airports, depending on the state of dispatch. You can deliver cargo by air directly to the airports of Ukraine. This option saves time, but a higher price must be considered. It is possible to reduce the cost of delivery when products are delivered by plane to some of the European airports and are already transported by road to a destination in Ukraine. It is possible to deliver cargo by air in this way within 20 days.
During transportation of pharmaceutical products to airports or seaports by road, containers with medicines in the back of a car should be placed in such a way as to ensure their stability in place during movement. The driver carrying out the transportation must have a medical record and a preventive medical examination.