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2015年8月31日,国家食品药品监督管理总局通过第16号总局令,发布《食品生产许可管理办法》(以下简称《办法》),《办法》包括总则,申请与受理,审查与决定,许可证管理,变更、延续、补办与注销,监督检查,法律责任,附件共八个章节,并于2015年10月1日实施。在实施前夕,2015年9月30日,总局向各省、自治区、直辖市、新疆生产建设兵团食品药品监督管理局发出了《食品药品监管总局关于贯彻实施〈食品生产许可管理办法〉的通知》(食药监食监一[2015]225号),以指导地方各级食品药品监督管理部门认真贯彻执行食品(含食品添加剂)生产许可制度。通知包括关于《办法》与原有规章制度的关系问题、关于食品生产许可审批权限下放、关于“一企一证”的实施、关于旧版食品生产许可证变更及延续、关于食品生产许可证编号标注及“QS”标志、关于食品生产许可证编号的食品类别编码、关于食品检验报告的核查、关于产业政策的执行、关于落实工作保障、关于加强行政许可监督等十个问题。制度实施以来,各地积极转变观念,加强制度宣传,深入贯彻总局改革思路和措施,多措并举推动食品生产许可改革工作落实,有效保证了食品生产许可改革工作顺利过渡。但由于此次制度修订变革事项较多,各地在实施过程中有政策把握不准、工作标准不统一的问题。为强化食品生产许可工作指导,统一工作规范,2017年6月13日,总局又发出《总局关于贯彻实施〈食品生产许可管理办法〉有关问题的通知》(食药监食监一[2017]53),就贯彻实施《办法》对许可审批有关问题、许可审查有关问题、证书管理及证后监管有关问题等事项进行了重申和明确,内容如下。
On August 31, 2015, the State Food and Drug Administration issued the “Measures for the Administration of Food Production Permits” (the “Measures”) through the Order No. 16 of the General Administration of Quality Supervision, Inspection and Quarantine (the “Regulations”), which includes the general provisions, application and acceptance, review and decision, License Management, Change, Renewal, Reissue and Cancellation, Supervision and Inspection, Legal Liability, Annex, a total of eight chapters, and in October 1, 2015 implementation. On the eve of the implementation, on September 30, 2015, the SAIC issued the “Notice of the General Administration of Food and Drug Administration on the Implementation of the” Measures for the Administration of Food Production Permits “to the provinces, autonomous regions, municipalities directly under the Central Government and the Xinjiang Production and Construction Corps, Food and Drug Administration Food and Drug Administration [2015] No. 225) to guide the local food and drug supervision and management departments at all levels to conscientiously implement the food (including food additives) production permit system. The circular includes the issue of the relationship between the ”Measures“ and the original rules and regulations, the delegated authority on examination and approval of food production licenses, the implementation of ”one enterprise, one license“, the change and continuation of the old version of food production licenses, Numbering and ”QS“ mark, food category code of food production license number, verification of food inspection report, implementation of industrial policy, implementation of job security, and supervision on ten issues such as strengthening administrative supervision. Since the implementation of the system, various localities have actively changed their concepts, strengthened institutional publicity, thoroughly implemented the ideas and measures for the reform of the General Administration of Public Administration, promoted the implementation of the reform of the food production license by multiple measures and effectively ensured the smooth transition of the food production license reform. However, due to the fact that many changes have been made in this system, all localities have some problems in implementing such policies. In order to strengthen guidance on food production permission work and standardize work, on June 13, 2017, the SAIC also issued the ”Notice of the SAIC on the Implementation of the“ Measures for the Administration of Food Production Permits ”(CFDA [2017] 53 ) On the implementation of the “Measures” on the licensing examination and approval issues related to licensing examination, certificate management and issues related to post-license supervision and other issues were reaffirmed and made clear as follows.