基于法规辨析假劣药认定检验受理情形  

Analyze the Acceptance Situation of Identification Test of Counterfeit and Inferior Drugs Based on Laws and Regulations

作　　者：张炜敏 黄清泉[1] 梁静 黄宝斌 ZHANG Weimin;HUANG Qingquan;LIANG Jing;HUANG Baobin(National Institutes for Food and Drug Control,Beijing 102629,China)

机构地区：[1]中国食品药品检定研究院,北京102629

出　　处：《医药导报》2023年第6期938-940,I0001,共4页Herald of Medicine

基　　金：中国食品药品检定研究院中青年发展研究基金资助项目[2020G1]。

摘　　要：2022年,最高人民法院、最高人民检察院联合发布《关于办理危害药品安全刑事案件适用法律若干问题的解释》(简称新司法解释)。新司法解释等法规对认定假劣药是否需检验结论作规定,但有的规定不够明确或存在不一致的情况,应依新司法解释受理假劣药认定检验,并在结合有关法规规定受理假劣药认定检验中,不断细化明确假劣药认定检验受理情形。对于2019年修订的《中华人民共和国药品管理法》第九十八条所列11种假劣药情形,属于该条第二款第四项、第三款第三至五项所列4种情形,可依规不予受理假劣药认定检验;属于第二款第一、三项和第三款第一、二、七项所列5种情形,可予受理;属于第二款第二项和第三款第六项所列2种情形,可附条件受理。对违禁使用、应批准未批准、应检验未检验等,进一步研判是否属于假劣药时需进行假劣药认定检验的,可予受理。In 2022,the Supreme People's Court and the Supreme People's Procuratorate jointly issued the interpretation on“Several issues concerning the application of law in handling criminal cases against drug safety(New Judicial Interpretation)”.The new judicial interpretation and other regulations stipulate whether identifying of counterfeit and inferior drugs requires test conclusions,but some provisions are not clear enough or there are inconsistencies.The identification test of counterfeit and inferior drugs should be accepted in accordance with the new judicial interpretation.In the acceptance of the identification test of counterfeit and inferior drugs in accordance with relevant laws and regulations,the circumstances of the acceptance should be continuously refined and clarified.For the 11 kinds of counterfeit and inferior drugs listed in Article 98 of the"Pharmaceutical Administration Law of the People's Republic of China"revised in 2019,which belong to the four situations,listed in item 4 of paragraph 2 and items 3 to 5 of paragraph 3 of this article,the identification test of counterfeit and inferior drugs may not be accepted according to regulations.If it belongs to the five situations,listed in items 1and 3 of paragraph 2 and items 1,2,and 7 of paragraph 3,the test may be accepted.The two other situations listed in item 2 of paragraph 2 and item 6 of paragraph 3 may be accepted with conditions.For prohibited use,items which should be approved or should be tested and other situations,or Where it is necessary to carry out a fake and inferior drug identification test when further researching and determining whether it is a fake or inferior drug,they can be accepted.

关 键 词：假劣药 司法解释 认定检验 

分 类 号：R951[医药卫生—药学]