According to Article 8 of the Law of the People's Republic of China on the Administration of Medicines:
The following conditions must be met in order to set up a pharmaceutical production enterprise:
(1) a pharmacy technician, engineering technician, and the corresponding skilled workers who have been qualified according to law;
(2) a plant, facilities, and sanitary environment that are appropriate for the production of the medicines it produces;
(3) institutions, personnel, and necessary instruments and equipment capable of carrying out quality control and quality testing of the medicines produced;
According to Article 8 of the Drug Administration Law, a drug production enterprise must have /p>
(c) have the quality of the drugs produced by the quality management and quality inspection of the institutions, personnel and the necessary equipment;
(d) have to ensure the quality of drugs and regulations.
Article 15 of the opening of pharmaceutical enterprises must have the following conditions:
(1) a qualified pharmacy technicians according to law;
(2) with the business premises, equipment, warehousing facilities, sanitation and environment appropriate to the operation of the drugs;
(3) with the operation of the pharmaceuticals appropriate to the quality of the management organization or personnel;
(4) with the quality of drugs produced, quality control and quality inspection agencies and necessary equipment and regulations to ensure the quality of the drugs. /p>
(d) have to ensure that the quality of the drugs operated by the rules and regulations.
According to the "Drug License Management Measures"
Article 4 in accordance with Article 14 of the Drug Administration Law, the opening of wholesale drug enterprises, shall comply with the requirements of the province, autonomous region and municipalities directly under the Central Drug Wholesale Enterprises of a reasonable layout, and comply with the following setup standards:
(I) has a guarantee of the quality of the drugs operated by the rules and regulations;
(ii) the enterprise, the enterprise's legal representative or personnel; and (ii) The enterprise, its legal representative or person in charge of the enterprise, and the person in charge of quality management do not have the circumstances stipulated in Articles 75 and 82 of the Drug Administration Law;
(iii) It has a certain number of practicing pharmacists appropriate to the scale of operation. The person in charge of quality management has a university degree or above, and must be a licensed pharmacist;
(d) has a room temperature warehouse, cool warehouse, cold warehouse that can ensure the quality requirements for the storage of medicines, and that is suitable for the variety and scale of its business. The warehouse has special shelves suitable for the storage of drugs and devices and equipments for realizing the modern logistics system of drug entry, transmission, sorting, shelving and exit;
(v) it has an independent computer management information system, which can cover the whole process of drug purchase, storage, sale, operation and quality control in the enterprise; it can comprehensively record the information on the management of business operation and the implementation of the "Code of Practice for the Quality Management of Pharmaceutical Business"; it is in line with the "Code of Practice for the Quality Management of Pharmaceutical Business"; and it is in line with the "Code of Practice for the Management of Pharmaceutical Business". Information; in line with the "Good Manufacturing Practice" on the requirements of the various aspects of drug business, and has the conditions to realize the acceptance of the local food and drug supervision and management department supervision;
(f) with the "Good Manufacturing Practice" on the drug business premises and auxiliary, office space and warehouse management, quality and safety of the drugs in the warehouse, and in and out of the library, in the library storage and conservation Conditions.
The state on the operation of narcotic drugs, psychotropic drugs, toxic drugs for medical use, preventive biological products otherwise provided for, shall be subject to its provisions.
Expanded Information
Article 31 The production of new drugs or drugs for which national standards have been set shall be approved by the State Council's drug supervision and administration department and issued with an approval number for the drug; however, the production of Chinese herbal medicines and traditional Chinese medicinal herbs and Chinese herbal medicinal tablets for which the management of the approval number has not been implemented is excluded. The implementation of the approval number management of Chinese herbal medicines, Chinese medicine varieties catalog by the State Council drug supervision and management department in conjunction with the State Council administration of traditional Chinese medicine to develop.
Drug manufacturers can only produce the drug after obtaining the approval number.
Article 32 drugs must comply with national drug standards. Chinese medicine tablets in accordance with the provisions of the second paragraph of Article 10 of this Law.
The drug supervision and management department of the State Council promulgated the "Chinese People's **** and the National Pharmacopoeia" and drug standards for the national drug standards.
The drug administration department of the State Council organizes the Pharmacopoeia Committee, which is responsible for the formulation and revision of national drug standards.
The State Council drug supervision and management department of the drug testing organization is responsible for calibrating the national drug standards, control products.
Article 48 prohibits the production (including preparation, the same below) and sale of counterfeit medicines.
One of the following circumstances is a fake drug:
(1) the drug contains ingredients that do not match the ingredients specified in the national drug standard;
(2) passing off a non-pharmaceutical drug as a pharmaceutical product, or passing off another type of pharmaceutical product as such a pharmaceutical product.
Drugs in one of the following circumstances shall be dealt with as counterfeit drugs:
(1) those whose use is prohibited under the provisions of the State Council's drug supervision and administration department;
(2) those which must be approved in accordance with this Law but are manufactured or imported without approval, or those which must be tested in accordance with this Law but are sold without such testing; and
(3) those which are sold in accordance with this Law but are not approved by the State Council; and
(4) those which are sold in accordance with this Law. [3]?
(3) deteriorated;
(4) contaminated;
(5) the use of raw materials in accordance with this Law must be approved without obtaining the approval number of the production of raw materials;
(6) labeled indications or functions beyond the scope of the provisions.
Article 49 prohibits the production and sale of substandard drugs.
If the content of a pharmaceutical ingredient does not conform to national pharmaceutical standards, it is an inferior drug.
Drugs with one of the following circumstances shall be dealt with as inferior drugs:
(1) failure to indicate the expiration date or change the expiration date;
(2) failure to indicate or change the production lot number;
(3) exceeding the expiration date;
(4) unauthorized packaging materials and containers in direct contact with drugs;
(5) Unauthorized addition of coloring agents, preservatives, spices, flavoring agents and excipients;
(vi) Other non-compliance with the provisions of the drug standard.
Article 50 is included in the national drug standards for the drug name is the generic name of the drug. Has been used as a generic name of drugs, the name shall not be used as a pharmaceutical trademark.
Article 51 of the drug manufacturers, drug companies and medical institutions in direct contact with the staff of the drug, must be an annual health examination. Suffering from infectious diseases or other diseases that may contaminate the drugs, shall not be engaged in direct contact with drugs.
Article 52 of the packaging materials and containers in direct contact with medicines must meet the requirements of medicinal use, in line with the standards for safeguarding human health and safety, and by the drug supervision and management department in the approval of medicines together.
Drug manufacturers shall not use unapproved packaging materials and containers that come into direct contact with drugs.
The unqualified packaging materials and containers for direct contact with drugs shall be ordered to stop using by the drug supervision and management department.
Article 53 of the drug packaging must be suitable for the requirements of the quality of drugs, convenient storage, transportation and medical use.
Shipping Chinese herbal medicines must be packaged. On each package, must indicate the name, origin, date, transfer unit, and accompanied by a sign of quality.
Article 54 of the drug packaging must be printed or labeled in accordance with the provisions and instructions.
The label or instructions must indicate the generic name of the drug, ingredients, specifications, manufacturer, approval number, product lot number, date of manufacture, expiration date, indications or functions, usage, dosage, contraindications, adverse reactions and precautions.
The labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radiopharmaceuticals, medicines for external use, and over-the-counter medicines must bear the prescribed symbols.
Baidu Encyclopedia - Chinese People's **** and State Drug Administration Law
Baidu Encyclopedia - Measures for the Administration of Drug Licenses