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EnVBK provides a full range of logistics and transport services necessary for international transport of medication, as well as transport of medical equipment and medical products. Our company pays special attention to the safety and security of the transported cargo, so transportation is carried out in accordance with the standards of distribution practice (GDP – Good Distribution Practice), international law and legislation in the field of turnover of medicines. VBK helps our Clients to establish a continuous delivery of medication and medical equipment in intercity and international traffic. Our company organizes transportation of medication and equipment by various means of transport in the regions of Europe, the CIS, the Baltic States, the Balkans, and Southeast Asia. In addition to standard customs procedures, we offer customs clearance of medical equipment for international exhibitions and conferences, for clinical esearch in temporary import mode (including under the A. T. A Carnet). VBK guarantees its clients the passage of control authorities (sanitary-epidemiological, environmental, phytosanitary, veterinary-sanitary, radiological control).
Types of cargo transported for the pharmaceutical/medical industry
VBK organizes transportation and customs clearance of the following categories of cargo for the medical industry:
- ready-made registered / unregistered medicines;
- standard samples, substances, placebo;
- registered / unregistered medical equipment and medical devices;
- laboratory sets and all types of medical instruments for conducting clinical research;
- reagents;
- veterenary preparations;
- biologically active additives.
Transportation of medical devices
The first type of cargo is medication. Medicines are a broad category that includes plant and synthetic compounds that differ in their physical and chemical properties. Many medicines are sensitive to fluctuations in temperature and humidity, to the level of lighting, and are also fragile goods. For example, liquid medicines are stored in fragile glass packages. To avoid damage to such cargoes, liquid medicines are fixed on the vehicle, and packaging material is placed in empty spaces and gaps to protect against mechanical damage.
The second type of cargo is medical devices. Medical devices include a wide range of instruments, devices, materials, reagents and devices that are used for medical purposes. During transportation the quality of such goods must not be compromised and must preserve their performance properties. Medical devices, as well as medicines, are subject to mandatory labeling, which helps to ensure proper transportation and storage conditions.
The third type of cargo is medical equipment. This high-tech equipment belongs to the categories of high value and fragile cargo, which largely determines the requirements for its transportation. In addition, medical equipment often has a non-standard configuration and size, so it is classified as oversized cargo.
VBK carefully monitors changes in national and international legal regulation of cargo transportation and ensures safe and fast transportation of medical devices and medication based on the characteristics of each specific product.
Features of customs clearance of pharmaceutical goods and cargo for the medical industry
Features of customs clearance of pharmaceutical goods and cargo for the medical industry:
By customs clearance of medical devices the following features must be taken into account:
Medical devices (IMS) are medical devices made of glass, polymer, rubber, textile and other materials, sets of reagents and control materials for them, other consumables and products that are mainly single — use, do not require maintenance when used.
Features of customs clearance of medical equipment
- Customs clearance of medical equipment is possible only if it is registered in the official state Register of medical devices.
- In some cases, testing of medical devices is required on the basis of the State control Department for The test period does not exceed 30 days.
- Byimport particularly complex equipment, the testing period may be extended to three months.
- Documents required for customs clearance of medical equipment:
- Information about technical parameters and equipment purpose;
- Illustrated catalogs of medical equipment that contain the product;
- Certificate of origin;
- Documents on registration of the equipment manufacturer, manualin Russian;
- Certificate of compliance with GOST of the Russian Federation and other standards (for example, when importing radio-electronic equipment, a conclusion from the radio Frequency center is required).
The CN FEA code:
Medical devices( IMS): to classify a product, you need to know the purpose and application of the product, as well as the technical characteristics of products that are difficult from a structural point of view (for example, for MRI, you need to know the frequency of operation of the RF generator and its power, since this product must, among other things, obtain an import license from the Ministry of industry and trade). They are also subject to exemption from VAT or payment of 10% in the presence of a Registration certificate of the Ministry of health (RU).
Certification of this products is regulated by the following regulatory documents:
- TR CU (technical regulation of the Custom Union) 010/2011 “On the safety of machinery and equipment»
- TR CU (technical regulation of the Custom Union) 004/2011 “On the safety of low-voltage equipment»
- TR CU (technical regulation of the Custom Union) 020/2011 “Electromagnetic compatibility of technical means»
- TR CU (technical regulation of the Custom Union) 032/2013 “On the safety of equipment operating under excessive pressure»;
- Other technical regulation of the Custom Union