Transport of medicines

Medicinal products must be protected from the effects of temperature, humidity and all external factors that may impair their quality and integrity. The vehicles used for their transport must be suitable for the purpose, and the supply of medicinal products containing, for example, narcotic drugs and psychotropic substances, requires special conditions to ensure their safety and security in accordance with the requirements laid down by the countries concerned.
Medicinal products can be transported in containers that do not adversely affect the quality of the products and offer adequate protection from external influences, including contamination. The choice of container and packaging should be made on the basis of the requirements for storage and transport of medicinal products; the space required for a given quantity of medicinal products; the expected final ambient temperatures; the estimated maximum time for transportation, incl. storage in customs transit warehouses; the quality of packaging and transport containers. Containers must be labeled to provide sufficient information regarding the requirements for handling, storage and precautions to ensure that they are handled properly and protected at all times. Containers must allow identification of the contents and their source.
Medicinal products containing high activity materials and radioactive materials should be transported in safe, specialized and safe containers and vehicles. Appropriate safeguards must comply with the provisions of international agreements and national law. For temperature-sensitive products, equipment with appropriate characteristics (eg thermal packaging, containers or temperature-controlled vehicles) should be used to ensure that the correct transport conditions are maintained between the manufacturer, the wholesale distributor and the customer. When using temperature-controlled vehicles, the temperature monitoring equipment used during transport should be maintained and periodically calibrated. Temperature maps should be prepared under representative conditions, taking into account seasonal variations. Where necessary, information must be provided to customers to demonstrate compliance with the storage temperature conditions of the products. If refrigeration packages are used in thermally insulated boxes, they must be arranged in such a way that the product does not come into direct contact with the refrigeration package. Personnel must be trained in the procedures for working with insulated boxes (seasonal configurations) and for reusing refrigeration packages. A system for controlling the re-use of refrigeration packaging should be established to ensure that refrigeration packaging that is not completely refrigerated will not be used by mistake. Appropriate physical separation between frozen and refrigerated ice packs is required. The process of delivery of sensitive products and the control of seasonal temperature deviations should be described in a written procedure.
All documents should be sufficiently detailed, written clearly and unambiguously.
Source https://eur-lex.europa.eu/

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*Excuse us if there is an inaccuracy in the translation - a common translator is used.