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State Council amends vaccine regulations

Updated: Apr 25,2016 5:04 PM     english.gov.cn

The State Council on April 24 passed an amendment to the Regulations for the Circulation and Inoculation of Vaccines in which a number of articles have been altered or modified, as follows:

Provincial centers for disease control and prevention will centralize purchase of type-2 vaccines on provincial platforms for public resources transaction, while centers at county levels will purchase vaccines from vaccine manufacturing enterprises and supply the inoculation unit within the administrative area.

Vaccine manufacturing enterprises should directly dispatch the type-2 vaccines to county centers for disease control and prevention, or authorize enterprises which meet the requirements for cold chain storage and transportation.

The center for disease control and prevention, inoculation unit, vaccine manufacturing enterprises and enterprises that are authorized for the distribution of vaccines are required to abide by the rules on the storage and transportation of vaccines, ensuring the vaccines being kept at the required temperature during the whole process, and regularly monitor the temperatures.

In accordance with the Law on the Administration of Drugs and rules from the national drug watchdog, vaccine production enterprises should establish a real and complete sales record concerning the purchase, storage, distribution and supply of vaccines, saving them until two years after the vaccines’ expiry dates.

In receiving type-1 vaccines or purchasing type-2 vaccines, inoculation units should ask for a temperature monitoring record for the storage and transportation of vaccines, and set up a complete purchasing and reception record.

Medical personnel should record vaccine type and vaccine production enterprises, identifying information on the smallest unit of packaging, the expiry date, medical personnel who conduct the inoculation, inoculation time and people who received vaccination. The inoculation record should be saved for no less than five years.

For those who show abnormal reactions after taking type-1 vaccines and need to be compensated, the compensation expenses will be allocated from budgets for vaccine inoculation by financial departments at the provincial, autonomous region, and municipalities’ governments; for abnormal reactions resulting from taking type-2 vaccines, vaccine manufacturing enterprises will be responsible for compensation expenses.

The amendment also required vaccine manufacturing enterprises, center for disease control and prevention and the inoculation unit to establish a trace system for monitoring the circulation and use of vaccines, as well as achieving the whole process of production, storage, transportation and use of vaccines traceable through checking the smallest packaging of vaccines.

Centers for disease control and prevention and inoculation units are required to truthfully register and report to a county drug watchdog concerning vaccines that have unidentified packaging, an overdue expiry date, detached from cold chain, failed to meet requirement, or unidentified source. County drug supervision department and health authorities should supervise the destruction of these vaccines with the destruction record to be kept for no less than five years.

According to the general rule on the Regulations for the Circulation and Inoculation of Vaccines, there are two types of vaccines in China. Type-1 are compulsory vaccines offered by the government for free, which include vaccines within the category of the nation’s immunization program. These also include vaccines that provincial, autonomous region, and municipalities governments added in carrying out the immunization program, as well as vaccines that are used for urgent and preventive inoculation. Type-2 vaccines are non-compulsory and should be paid for inoculation.

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