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

On July 14, the State Drug Administration issued a letter to the Guizhou Provincial Drug Administration, clarifying the issue of the identification of counterfeit drugs.
reply notes that there are six cases in which the quality inspection conclusions of the drug inspection institution need not be specified in the decision on the punishment of counterfeit and inferior drugs.
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" is recognized as a counterfeit medicine, and according to Article 98( 3rd, paragraph 3, paragraph 7, to 7) of the Drug Administration Law, the drug is considered to be inferior, only the facts are determined that the drug involved is not required to be tested, and the penalty decision does not need to specify the quality testing conclusions of the drug testing institution.
, therefore, 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 main treatment of the function beyond the prescribed scope; the drugs that do not indicate or change the validity period; the drugs that do not indicate or change the product batch number; the drugs that exceed the validity period; the drugs that add preservatives and accessories without authorization; and the other drugs that do not meet the drug standards.
further pointed out that the determination of counterfeit and inferior drugs should be dealt with in accordance with the interpretation of the Supreme People's Court on certain questions of the law applicable to the handling of criminal cases against drug safety (Authorization (2014) No. 14), i.e. whether it is a counterfeit drug or a bad drug is difficult to determine, the judicial organ may determine the relevant materials such as the opinions issued by the supervision and administration of drugs at or above the municipal level. if necessary, the
may entrust the drug inspection institutionset or determined by the drug supervision and administration department at or above the provincial level for examination.
reply stressed that the fact of illegal acts should be based on legal, effective and sufficient evidence, drug quality inspection conclusions are not necessary evidence to determine illegal acts, unless laws, regulations, regulations and other clearly provided for the drug involved 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 law can not be determined the facts of the case.
If 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.
the 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 Administration Law of the People's Republic of China on the identification of counterfeit drugs related to the request" (2020) No. 20) received.
since 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 institutions.
is 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 institution.
the 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) No. 14), 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 level. if necessary, the
may entrust the drug inspection institutionset or determined by the drug supervision and administration department at or above the provincial level for examination.
in 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 case.
If 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.
the Integrated Division of the State Drug Administration on July 10, 2020.