State Drug Administration: The penalty decision of counterfeit and inferior drugs does not require the conclusion of drug quality inspection.

On July 14th, the State Drug Administration issued a "Reply Letter from the General Department of the State Drug Administration on the issue of the identification of counterfeit and inferior drugs", which clearly determined the decision on the punishment of counterfeit and inferior drugs, some of which do not need to include the quality inspection conclusions of the drug inspection institutionsfull text reply is as follows: Guizhou Provincial Drug Administration: Your Bureau "on the newly revised Drug Administration Law of the People's Republic of China on the identification of counterfeit drugs related to the request" (The Drug Supervision (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 the quality inspection conclusions of the drug inspection institutions"conducting business with the National People's Congress Law and Industry Commission, the letter is as follows: the punishment of counterfeit drugs, inferior drugs, some do not need to include the quality inspection conclusions of drug inspection institutionsis recognized as a counterfeit drug in accordance with Article 98, paragraph 2, paragraph 4, of the Drug Administration Law, "The indications identified by the drug or the main treatment of the function is beyond the prescribed scope", and as a result of the fact that the drug in question is determined to be inferior, and the penalty decision does not require the quality conclusion of the drug testing institutionthe determination of counterfeit and inferior drugs, and shall be dealt with in accordance with the 14th Provisions of the Interpretation of the Supreme People's Procuratorate of the Supreme People's Court on Certain Questions of the Law Applying to 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 relevant materials such as the opinions issued by the drug supervision and administration department at or above the municipal levelif necessary, themay entrust the drug inspection institutionset or determined by the drug supervision and administration department at or above the provincial level for examinationin general, the fact of illegal acts should be based on legal, effective and sufficient evidence, the drug quality inspection conclusion is not necessary for the determination of illegal acts, unless the law, regulations, regulations and other clearly provided for the drug involved in the law and based on the quality testing conclusion to determine the illegal facts, or not to test the drugs involved in the law can not be determined the facts involved in the caseIf the drugs produced by the black nest site require quality inspection, the specific case of the investigation and collection of evidence shall be analyzed according to the case.