Opening a pharmaceutical business enterprise must have the following conditions:
1, with the qualification of pharmacy technicians;
2, with the operation of the drugs appropriate business premises, equipment, storage facilities, sanitation environment;
3, with the operation of the drugs appropriate quality management organization or personnel;
4, with the Ensure the quality of the drugs operated by the rules and regulations.
Drugs shall be examined by the State Council Drug Administration, the examination confirmed to meet the quality standards, safety and efficacy before approval of the import, and issue a certificate of registration of 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.
"People's Republic of China *** and the State Drug Administration Law" Article 28 of the drugs should be in line with national drug standards. Drug quality standards approved by the State Council drug supervision and management department is higher than the national drug standards, in accordance with the approved drug quality standards; there is no national drug standards, shall comply with the approved drug quality standards.
The State Council Drug Administration promulgated the "Chinese People's *** and the National Pharmacopoeia" and drug standards for the national drug standards.
The drug supervision and administration department of the State Council, in conjunction with the competent health department of the State Council, organizes the Pharmacopoeia Committee, which is responsible for the formulation and revision of national drug standards.
The drug testing organizations set up or designated by the State Council department of drug supervision and administration are responsible for calibrating the national drug standards and controls.
Article 32 of the Law of the People's Republic of China on the Administration of Medicines The holder of a marketing authorization for a medicine may produce the medicine itself, or may entrust the production of the medicine to a pharmaceutical manufacturer. The holder of a listed drug license to produce their own drugs, shall obtain a drug production license in accordance with the provisions of this Law; commissioned production, shall be entrusted to meet the conditions of the drug production enterprises. The holder of a listed drug license and the entrusted production enterprise shall sign a commissioning agreement and quality agreement, and strictly fulfill the obligations agreed upon. The drug supervision and management department of the state council to formulate drug commissioned the production of quality agreement guidelines, guidance and supervision of drug license holders and commissioned production enterprises to fulfill the obligations of drug quality assurance.
Blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, and pharmaceutical chemicals shall not be entrusted with the production; however, except as otherwise provided by the Drug Administration under the State Council.