State Drug Administration: 6 cases of identification of counterfeit drugs do not need to issue an inspection report.

Pharmaceutical Network July 16th, July 14, the State Drug Administration openly sent a letter to the Guizhou Provincial Drug Administration, clear about the identification of counterfeit drugsThe reply notes that there are six cases in which the quality inspection conclusions of the drug inspection institution need not be specified in the penalty decision for counterfeit and inferior drugsThe reply states that according to Article 98, paragraph 2, paragraph 4, of the Drug Administration Law, "the indications identified by the drug or the main treatment of functions beyond the prescribed scope" are considered to be counterfeit drugs, and that the third to seventh items of Article 98 of the Drug Administration Act are considered inferior, only the facts are required to determine that the drug involved is not required to be tested, and the penalty decision does not require the quality inspection conclusions of the drug inspection institutionsTherefore, the six cases in which the quality inspection conclusions of the drug inspection institution are not required are: the indications indicated by the drug or the function of the main treatment beyond the prescribed scope; the drug that does not indicate or change the validity period; the drug that does not indicate or change the product batch number; the drug that exceeds the validity period; the drug that adds preservatives and accessories without authorization; and other drugs that do not meet the drug standardsThe reply further states that the determination of counterfeit and inferior drugs shall be dealt with in accordance with the 14th Provisions of the Interpretation of the Supreme People's Procuratorate on certain questions of the law applicable to the handling of criminal cases against drug safety (Authorization (2014) No14), that is, whether it is a counterfeit drug or a bad drug is difficult to determine, the judicial organ may make a determination according to the relevant materials issued by the drug supervision and administration department at or above the municipal levelIf necessary, the drug inspection institutions set up or determined by the drug supervision and administration departments at or above the provincial level may be entrusted to carry out the inspectionThe reply emphasizes that the fact of illegal acts should be based on legal, effective and sufficient evidence, and that the conclusion of drug quality inspection is not necessary for the determination of illegal acts, unless the law, regulations, regulations and other clearly provide disqualifying the drugs involved in the case in accordance with the law and based on the quality inspection conclusions to determine the illegal facts, or not to test the drugs involved in the case according to law can not be determined the facts involved in the caseIf the drugs produced in the black nest point need to carry out quality inspection, the specific case of the case should be analyzed according to the case investigation and evidence collectionThe General Department of the State Drug Administration on the identification of counterfeit drugs related to the relevant issues of the Guizhou Provincial Drug Administration: your Bureau "on the newly revised drug management law of the People's Republic of China, the people's republic of China, the drug management law, the request for the identification of counterfeit drugs related to the issue" (The Drug Administration (2020) No20) receivedSince the promulgation and implementation of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law), different understandings have been made about the application of Article 121 "The decision on the punishment of counterfeit and inferior drugs shall be set out in accordance with the law by the quality inspection conclusions of the drug inspection institutions"In doing business with the National People's Congress/Law/Industry Committee, the present letter is as follows: the penalty decision for counterfeit and inferior drugs, some do not need to include the quality inspection conclusions of the drug inspection institutionsAccording to Article 98, paragraph 2, paragraph 4, of the Drug Administration Law, "the indications identified by the drug or the main treatment of functions beyond the prescribed scope" are recognized as counterfeit drugs, and according to Article 98( 3rd, paragraph 3, paragraph 7, and article 7 to 7) of the Drug Administration Law, only the facts are found that the drug involved does not need to be tested, and the penalty decision does not need to specify the quality conclusion of the drug testing institutionWith regard to the determination of counterfeit and inferior drugs, the judicial organ may, in accordance with the interpretation of the Supreme People's Procuratorate of the Supreme People's Court on certain questions of the law applicable to the handling of criminal cases against drug safety (Authorization (2014) No14), determine whether it is a counterfeit drug or a bad drug, and the judicial organ may make a determination according to the relevant materials such as the opinion selling the opinion issued by the drug supervision and administration department at or above the municipal levelIf necessary, the drug inspection institutions set up or determined by the drug supervision and administration departments at or above the provincial level may be entrusted to carry out the inspection In short, the facts of the illegal act should be determined on the basis of legal, effective and sufficient evidence, the conclusion of drug quality inspection is not necessary to determine the illegal act, unless the law, regulations, regulations and other clearly provide disclaimed the drug in accordance with the law and based on the quality test ingons to determine the illegal facts, or not to test the drugs involved in the law according to law can not be identified the facts involved in the case If the drugs produced in the black nest point need to carry out quality inspection, the specific case of the case should be analyzed according to the case investigation and evidence collection July 10, 2020 in the Integrated Division of the State Drug Administration.