进口消毒产品卫生安全评价行政处罚探讨

Discussion of Administrative Punishment on Hygienic Safety Evaluation of Imported Disinfection Products

本文基于一起进口抗抑菌制剂在华责任单位经营产品卫生质量不符合要求的行政处罚案件,在产品责任单位认定、违法行为查证、行政处罚法律适用等方面进行了分析。通过案例分析,对进口消毒产品卫生安全评价的行政处罚提炼出案件办理的思路方法和技巧。进口消毒产品的在华责任单位应依据合法有效的授权书进行认定;在华责任单位违反卫生安全评价规定的违法行为查证要点包括产品上市行为的确定和未进行卫生安全评价两个方面;对于第一类、第二类消毒产品首次上市前未进行卫生安全评价的违法行为,应按生产经营产品卫生质量不符合要求的消毒产品的违法行为进行处罚。在推进消毒产品卫生安全评价管理方面提出建议:消毒产品卫生监督应以消毒产品卫生安全评价为抓手加强市场流通监管;抗(抑)制菌剂的消毒产品属性名称应依据消毒产品分类目录进行规范统一;进口消毒产品的产品责任单位应被规范认定,有效规避产品责任法律风险;建立和完善消毒产品行政处罚裁量基准制度;建立统一的进口消毒产品信息数据平台,完善进口消毒产品卫生安全评价的监管体系。

This article analyzed an administrative punishment case of imported antibacterial and bacteriostatic agents which did not meet the quality requirements of disinfection products, and discussed the identification of disinlection products liability, the identification of illegal acts and the law application of administrative punishment. From this case the authors put forward such conclusions as that the liability unit of imported disinfection products should be identified according to the letter of authorization of loreign corporation, and that behaviors of first listed sales and the absence of hygienic salety evaluation report are the two key points to confirm the violations of hygienic safely evaluation regulations, and that due to illegal acts of absence of hygienic salety evaluation reports before the first listed sales of the first and second category disinfection products, the punishment should be applicable to the violation of production and marketing disinfection products missed the requirements of the hygiene quality. The authors provide such measures to improve supervision and management on hygienic salety evaluation of imported disinfection products： to strengthen the supervision of hygienic salary evaluation on disinfectant products in market circulation fied, to promote standardization and unification of property of antibacterial and bacteriostatic agents based on the classilication catalogues of disinfection products, to effectively identify liability unit of imported disinfection products so as to avoid legal risk of disinfection products liability, to establish and improve the criterion of administrative punishment for disinfection products, and to establish unified information network platform for hygierdc safety evaluation regulations on imported disinfection products.