疫苗是含有生物活性物质的特殊药品,疫苗的储存和运输对温度有一定的冷链要求。山东疫苗案件之后国家陆续发布了一系列法律法规,进一步加强疫苗的生产、流通、接种管理。此文对疫苗流通管理相关的法律法规按时间顺序进行系统梳理和分析,旨在为疫苗生产、配送、储存企业以及接种单位等理清法律法规脉络,为其更好地开展疫苗流通管理提供法律法规依据。
Vaccine is a special drug containing bioactive substances, and the storage and transportation of vaccine have certain cold chain requirements on temperature. After the Shandong vaccine case, a series of laws and regulations have been issued to further strengthen the management of vaccine production, circulation and vaccination. In this paper, the laws and regulations related to vaccine circulation management are systematically combed and analyzed in chronological order, aiming at clarifying the context of laws and regulations for vaccine production, distribution, storage enterprises and vaccination agencies, and providing legal and regulatory basis for them to better carry out vaccine circulation management.
周振歆,赵冰心,苗睿,等. 我国疫苗流通管理法律法规浅析[J]. 国际生物制品学杂志,2025,48(01):55-59.
DOI:10.3760/cma.j.cn311962-20240730-00053版权归中华医学会所有。
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