New requirements for vaccine circulation come into force in Ukraine: what has changed

Today, May 27, new requirements for the storage, transportation, acceptance and accounting of vaccines and other medical immunobiological preparations (MIBP) came into force in Ukraine. UNN tells what the updated order of the Ministry of Health provides for. 

Details 

On October 2 of last year, the Ministry of Health approved new requirements for the storage, transportation, acceptance and accounting of vaccines and other medical immunobiological preparations by order No. 1682. According to the order, the main components of the cold chain system (CCL) - a system that ensures the necessary conditions for the storage and transportation of medical immunobiological preparations – vaccines, anatoxins - from the manufacturer to the person being vaccinated - are: 

• specially trained personnel that provides maintenance of refrigeration and other auxiliary equipment, systems and devices for continuous temperature monitoring for the storage and transportation of MIBP at all levels of the cold chain;
• refrigeration equipment and other auxiliary equipment, systems and devices for continuous temperature monitoring, vehicles that provide proper conditions for the storage and transportation of MIBP;
• continuous monitoring of compliance with cold chain conditions at all its stages.

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Registration of MIBP storage conditions is mandatory at all levels of the CCL. Registration of storage conditions is carried out in writing or electronically. According to the order, it is now prohibited to use household refrigerators for the storage of MIBP. Only specialized refrigeration equipment is allowed. Household refrigerators can only be used for the storage of cold elements.

New requirements are also being established for thermal containers and thermal bags. They must maintain a temperature of +2°C to +8°C for at least 24 hours at an ambient temperature of up to +43°C and at least 10 hours at a temperature of up to -30°C. The use of household camping bags is prohibited. 

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It is also noted that the transportation of immunobiological preparations must take place in specialized thermal containers or thermal bags together with temperature recorders. Transportation of large batches of MIBP without the use of thermal containers or thermal bags is carried out by specialized transport equipped with refrigeration units in the temperature regime established by the manufacturer. 

Thermal containers or thermal bags intended for the transportation of MIBP must be without violation of integrity, in proper sanitary and technical condition.

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Loading of MIBP into thermal containers or thermal bags is carried out in a cold room. If it is impossible to load MIBP in a cold room, it is allowed to load them at room temperature for a period not exceeding 5 minutes.

Upon arrival of immunobiological preparations at medical facilities, conditions are created for their storage in accordance with the requirements of the cold chain and instructions for medical use. Upon receipt of MIBP, they are placed in refrigeration equipment within 10 minutes, checking the readings of measuring instruments. 

In case of violation of the storage or transportation regime, or in case of doubts about the quality, after drawing up an acceptance certificate, the preparations must be placed in a separate quarantine zone of the refrigeration equipment and the violation must be reported. 

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