The establishment of a pharmaceutical production enterprise must meet the following conditions:

(1) Having qualified pharmaceutical technicians, engineering technicians and corresponding skilled workers according to law;

(2) Having factories, facilities and sanitary environment suitable for its pharmaceutical production;

(3) Having institutions, personnel and necessary instruments and equipment capable of quality management and quality inspection of the drugs produced;

(4) Having rules and regulations to ensure the quality of drugs.

Article 15 To establish a pharmaceutical trading enterprise, the following conditions must be met:

(1) Having qualified pharmaceutical technicians according to law;

(2) Having business premises, equipment, storage facilities and sanitary environment suitable for the drugs handled;

(3) It has a quality management organization or personnel suitable for the drugs it deals in;

(4) Having rules and regulations to ensure the quality of the drugs handled.

According to the provisions of the Measures for the Administration of Drug Business License

Article 4 According to Article 14 of the Drug Administration Law, the establishment of pharmaceutical wholesale enterprises shall meet the requirements of rational distribution of pharmaceutical wholesale enterprises in provinces, autonomous regions and municipalities directly under the Central Government, and meet the following setting standards:

(1) It has rules and regulations to ensure the quality of the drugs it deals in;

(2) The enterprise and its legal representative or the person in charge of the enterprise and the person in charge of quality management have no circumstances as stipulated in Articles 75 and 82 of the Drug Administration Law;

(3) Having a certain number of licensed pharmacists suitable for the business scale. The person in charge of quality management has a college degree or above and must be a licensed pharmacist;

(4) Having normal-temperature warehouses, refrigerated warehouses and frozen warehouses that meet the quality requirements for drug storage and are suitable for its business variety and scale. The warehouse has special shelves suitable for drug storage and devices and equipment of modern logistics system for drug storage, transportation, sorting, shelving and delivery;

(5) Having an independent computer management information system, which can cover the whole process of drug procurement, storage, sales, management and quality control; Information that can comprehensively record the enterprise management and the implementation of the "Good Manufacturing Practices"; It meets the requirements of "Quality Management Standards for Drug Trading" on all aspects of drug trading, and has the conditions to accept the supervision of local food and drug supervision and management departments;

(6) It meets the requirements of drug business premises and auxiliary facilities, management of office buildings and warehouses, quality and safety guarantee of drugs in warehouses, storage and maintenance of drugs in warehouses.

If the state has other provisions on dealing in narcotic drugs, psychotropic drugs, toxic drugs for medical use and biological products for prevention, those provisions shall prevail.

Extended data

Article 31 The production of new drugs or drugs with national standards must be approved by the drug supervision and administration department of the State Council, and a drug approval number shall be issued; However, the production of Chinese herbal medicines and Chinese herbal pieces without the approval number management is excluded. The catalogue of varieties of Chinese herbal medicines and Chinese herbal pieces subject to the approval number management shall be formulated by the drug supervision and administration department of the State Council in conjunction with the administrative department of traditional Chinese medicine of the State Council.

A pharmaceutical production enterprise can produce the drug only after obtaining the drug approval number.

Article 32 Drugs must meet the national drug standards. Chinese herbal pieces shall be executed in accordance with the provisions of the second paragraph of Article 10 of this Law.

The Pharmacopoeia of People's Republic of China (PRC) and the drug standards promulgated by the drug supervision and administration department of the State Council are the national drug standards.

The State Council drug supervision and administration department organizes Pharmacopoeia Committee, which is responsible for the formulation and revision of national drug standards.

The drug inspection agency of the State Council drug supervision and administration department is responsible for calibrating the national drug standard and reference substance.

Article 48 The production (including preparation, the same below) and sale of counterfeit drugs are prohibited.

In any of the following circumstances, it is a counterfeit drug:

(a) the ingredients contained in the drug are inconsistent with the provisions of the national drug standards;

(2) passing off non-drugs as drugs or passing off other drugs as drugs.

Drugs under any of the following circumstances shall be treated as counterfeit drugs:

(a) prohibited by the drug supervision and administration department of the State Council;

(2) Producing, importing or selling without the approval of this Law; ? [3]?

(3) deterioration;

(4) being polluted;

(five) the use of raw materials that must obtain the approval number in accordance with this law, but have not obtained the approval number;

(six) the indications or functional indications are beyond the prescribed scope.

Article 49 The production and sale of inferior drugs are prohibited.

If the content of drug ingredients does not meet the national drug standards, it is inferior.

Drugs under any of the following circumstances shall be punished as inferior drugs:

(1) Failure to indicate the validity period or change the validity period;

(two) the production batch number is not marked or changed;

(three) beyond the validity period;

(4) The packaging materials and containers that come into direct contact with drugs are not approved;

(5) Adding colorants, preservatives, spices, correctants and auxiliary materials without authorization;

(six) other do not meet the requirements of drug standards.

Article 50 The names of drugs listed in the national drug standards are generic names of drugs. If it has been used as a generic name of a drug, the name shall not be used as a drug trademark.

Article 51 Staff members of pharmaceutical production enterprises, pharmaceutical trading enterprises and medical institutions who are in direct contact with drugs must undergo health examination every year. Persons suffering from infectious diseases or other diseases that may contaminate drugs shall not engage in direct contact with drugs.

Article 52 The packaging materials and containers that come into direct contact with drugs must meet the requirements for medicinal use, meet the standards for safeguarding human health and safety, and be examined and approved by the pharmaceutical supervisory and administrative department.

Pharmaceutical production enterprises shall not use unapproved packaging materials and containers that are in direct contact with drugs.

The pharmaceutical supervisory and administrative department shall order unqualified packaging materials and containers that come into direct contact with drugs to stop using them.

Article 53 The packaging of drugs must meet the quality requirements of drugs and be convenient for storage, transportation and medical use.

Chinese herbal medicines must be packed when transported. Each package must be marked with the name, place of origin, date and transshipment unit, and must be accompanied by a quality certificate.

Article 54 Drug packaging must be printed or affixed with instructions in accordance with regulations.

Labels or instructions must indicate the generic name, ingredients, specifications, manufacturer, approval number, product batch number, production date, expiration date, indications or functional indications, usage, dosage, contraindications, adverse reactions and precautions.

The labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and over-the-counter drugs must be marked with prescribed marks.

Baidu Encyclopedia-People's Republic of China (PRC) Drug Administration Law

Baidu Encyclopedia-Measures for the Administration of Drug Business License