In the absence of formal import procedures, the import of drugs without approval is defined as fake drugs, illegal trading is an illegal act.
According to Article 39 of the Drug Administration Law, the importation of drugs shall be subject to review by the State Council Drug Administration, which shall confirm compliance with quality standards, safety and efficacy before approval for importation and issue of registration certificates for imported drugs.
Medical units in urgent clinical need or personal use of imported medicines in small quantities, in accordance with the relevant provisions of the State for import procedures.
According to the "Chinese People's **** and State Criminal Law" Article 142 of the production and sale of substandard drugs, causing serious harm to human health, shall be sentenced to not less than three years and not more than ten years of fixed-term imprisonment, and shall be sentenced to sales of more than 50% of the amount of not less than two times the amount of the fine.
Where the consequences are particularly serious, the penalty shall be fixed-term imprisonment of not less than ten years or life imprisonment, and a fine of not less than fifty percent and not more than two times the amount of the sale or confiscation of property. The inferior drugs referred to in this article are those that are inferior in accordance with the provisions of the Chinese People's **** and State Drug Administration Law.
Expanded Information
According to Article 15 of the Drug Administration Law, the following conditions must be met in order to open a drug business enterprise:
I) have a pharmacy technician who has been accredited in accordance with the law;
II) have a place of business, equipment, warehousing facilities, and a sanitary environment suitable for the drugs being dealt in.
Third, with quality management organizations or personnel appropriate to the operation of drugs;
Fourth, with rules and regulations to ensure the quality of the drugs operated.
Article 16 Drug business enterprises must operate drugs in accordance with the "Drug Business Quality Management Standards" formulated by the State Council's drug supervision and management department in accordance with this Law.
The drug supervision and management department in accordance with the provisions of the drug business enterprises whether to meet the requirements of the "Drug Business Quality Management Specification" for certification; on the certification of qualified, the issuance of certificates of authentication.
The Specification for the Quality Management of Pharmaceutical Business specific implementation methods, implementation steps by the State Council drug supervision and management department.