In accordance with Article 48 of the Drug Administration Law of the People's Republic of China*** and the State of China, it is prohibited to produce (including configuration, the same below) and sell counterfeit drugs. One of the following two situations is a counterfeit medicine:
(1) the ingredients contained in the medicine do not conform to the ingredients stipulated in the national drug standard;
(2) the use of non-pharmaceutical drugs as medicines, or the use of other kinds of medicines as such medicines. These two cases are counterfeit medicines.
These circumstances are punishable as counterfeit drugs:
(a) the State Council Drug Administration prohibits the use of;
(b) in accordance with this Law must be approved without approval of the production, importation, or in accordance with this Law must be inspected without inspection of the sale;
(c) deterioration;
(d) contaminated;
(e) the use of raw materials in accordance with this Law must obtain approval of the name but did not obtain approval of the name of the production;
(f) labeled indications or functions beyond the scope of the provisions of the main.
The above six cases are dealt with as fake drugs. In addition, celebrities who endorse drugs that they know are counterfeit will be held criminally liable. The production and sale of counterfeit drugs, substandard drugs crime, is an intentional crime; constitute **** crime is to know or should know that others produce, sell counterfeit drugs, substandard drugs as a prerequisite.
Guaranteeing the safety, effectiveness, homogeneity and stability of medicines is the mission of every pharmaceutical person. Therefore, drug safety is highly valued. In addition, in daily life, consumers should also improve the awareness of identifying counterfeit medicines, master the simple method of identifying counterfeit medicines, and found that the phenomenon of sales and manufacturing of counterfeit medicines immediately reported to the relevant departments,*** with the responsibility for their own health and the health of others.
Expanded information:
The concept of counterfeit medicines and the circumstances in which they are dealt with as counterfeit medicines have been recognized by the current Drug Administration Law since December 1, 2001, when it was first promulgated. Administration Law has not been amended since December 1, 2001, when it was formally implemented. Prior to the introduction of the Criminal Law Amendment (VIII) in 2011, the crime of producing or selling counterfeit drugs was a dangerous crime, which could only be penalized if it caused harmful consequences.
As a result, there were relatively few cases involving the transfer of counterfeit drug cases and public security organs requesting the drug regulatory authorities to carry out the identification of counterfeit drugs, and the modes and circumstances of identification were relatively single and fixed.
Amendment (VIII) to the Criminal Law amended Article 141 of the Criminal Law, which stipulates that the crime of producing or selling counterfeit drugs is a dangerous crime to a crime of behavior, and eliminated the threshold of "sufficient to seriously endanger human health".
In particular, the Interpretation of the Supreme People's Court and the Supreme People's Procuratorate on Several Issues Concerning the Application of Law in Handling Criminal Cases of Endangering the Safety of Pharmaceuticals makes it clear that if it is difficult to determine whether or not it is a fake drug, "the judicial organ can make a determination on the basis of the determination opinion issued by the drug supervision and management department at or above the prefecture or municipal level, or any other relevant materials."
This not only further increases the crackdown on crimes against drug safety, but also puts forward higher requirements for drug regulators to recognize counterfeit drugs in the connection of execution and punishment.
Article 52 of the Drug Administration Law of the People's Republic of China stipulates that the following conditions should be met in order to engage in drug business activities:
(a) there are pharmacists or other pharmacy technicians who have been qualified according to law;
(b) there is a place of business, equipment, warehousing facilities and hygienic environment that is appropriate for the drugs being operated;
(c) there is a place of business, equipment, warehousing facilities and sanitary environment that is appropriate for the drugs being operated;
(c) there is a place of business that is suitable for the drugs being operated. There is a quality management organization or personnel appropriate to the operation of drugs;
(d) there are rules and regulations to ensure the quality of drugs, and in line with the State Council's drug supervision and management department in accordance with the requirements of the Drug Administration quality management standards developed under this law.
Baidu Encyclopedia - Drug Administration Law