(Adopted by Decree No. 112 of 27 December 2010 by the People's Government Order No. 112 of 27 December 2010)

Chapter I General

Article 1 ensures the quality and safety of medicines, medical equipment and human use in order to strengthen the monitoring of the circulation of medicines and medical equipment, and develops this approach in line with the laws and regulations such as the People's Republic of China's Medicine Management Act, the Medical Assurance Regulation Regulations.

Article 2

Article 3 Supervision of food-medical medicines in the district is responsible for the supervision of the distribution of medicines and medical equipment in the current administration.

The Government of the people at the district level, through UNCTAD, is responsible for researching development planning and industrial policies for the development of the pharmaceutical and medical-farm industries, leading to the industry, promoting technological progress and restructuring. More than veterans of food medicine surveillance management should work in conjunction with UNCTAD to implement the development planning and industrial policies of the drug and medical-use industries.

The health sector of the people at the district level is responsible for guiding the health-care agency's work on drug management, organizing the implementation of the national basic drug system and participating in the clinical testing of medicines and medical equipment.

The relevant sectors, such as population and family planning, price, quality technical supervision, business and public safety, are responsible, within their respective responsibilities, for oversight management related to the flow of medicines and medical equipment.

The commune Government should assist in the management of the flow of medicines, medical devices within the jurisdiction.

Article IV Medicines, medical equipment production, business and use units should guarantee the quality and safety of their procurement, sale, storage, transport, use of drugs and medical equipment.

Article 5 provides for the establishment of a medical reserve system by the Government of the province, under the principles of central harmonization policies, harmonization planning and harmonization of organizations, to guarantee the availability of medicines, medical equipment and equipment in the event of emergencies such as floods, epidemics.

The pharmaceutical reserve system is implemented by the provincial people's governments, organized by UNCTAD.

Article 6 provides incentives for units or individuals that make significant achievements in the management of drug, medical and arms circulation, and for more than veterans in the districts.

Chapter II

Article 7.

The production of medicines, the manufacturer shall not sell drugs to the unqualified pharmaceutical operators and the units.

Article 8

(i) The licensing of the production of medicines or the licensing of the operation of medicines and the copy of the licence of business;

(ii) The Guidelines for the Quality Management of Medicines or the certification certificate and approval of the Standards for the Quality Management of Medicine;

(iii) Authorization for the sale of medicines by the supply unit;

(iv) The effective identity of the salesr is evidence of the reproduction.

In accordance with the sale certificate and information retained in accordance with the provisions of this article, the pharmaceutical operation and the use unit shall be retained for more than three years of work for the effective duration of the medicines.

Article 9. Purchasing medicines by pharmaceutical operators and using units should be established and implemented in the delivery inspection inspection system, the identification of qualified medicines and other markings, and non-removable requests.

The purchase of medicines by pharmaceutical operators and using units must have a real and complete record of procurement tests, and the record of the procurement inspection should be confirmed by the signature of the recipient.

Article 10. The production of medicines, the sale of medicines by the manufacturer should be accompanied by a sales certificate indicating the name of the purchase unit, the generic name of the drug, the manufacturer, the manufacturer, the specifications, the number, prices, etc., and a seal.

The sale of medicines by the retailer of medicines should open a sale certificate indicating the name of medicines, the manufacturer, the quantity, prices, and the number.

The production of medicines and the sale of medicines by the operation must have a real and complete record of sales.

Article 11. The collection and sale of medicines should indicate the generic name of the medicine, the manufacturer (prescription of the pharmacies), the manufacture, specifications, the collection, the valid period, approval of books, purchase orders, the number of purchases, the purchase price, and the date of purchase.

The collection and sale of medicines should be kept for more than one year, but not less than three years.

Article 12 Medicine production, operation and use units should take appropriate refrigeration, defence, stifling, ventilation, ventilation, pests, anti-speaks, ratifications, transport of drugs, as required by drug standards and statements.

The production, operation and use units of medicines can entrust with the storage and transport of medicines that are in place to secure the quality of medicines.

Article 13 pharmacies and user units should conduct regular inspections of stockpiled medicines and non-qualified medicines, such as obsolete, contaminated, transgender, should be registered and destroyed in accordance with the relevant provisions.

Article 14.

Article 15. Notes of medicines, labels of adaptation or functional ownership shall not exceed the scope approved by the National Food Drugs Monitoring Administration.

Non-drug notes, labels and their advocacy information shall not contain content that relates to drug adaptation or functional ownership.

Article 16 provides for pharmacies, pharmacies or pharmacies established by medical institutions, and shall have conditions such as the appropriate premises, equipment, warehousing facilities, the sanitation environment, with specific conditions being developed and published by the Ministry's Government's Food Medicine Monitoring Administration and the health sector.

Article 17 The drug use unit should provide the patient with medicines by the medical doctor and should not be sold or sold in an open counter cell for self-selection, probationary, co-patientation, counselling, etc.

Chapter III

Article 18

Medical-arm operators shall not operate medical equipment that is not registered, free of charge, expired or phased out. Medical devices are not allowed to use unregistered, unqualified, expired or phased medical devices.

Article 19 Medical operators and use units for the procurement of medical equipment should be requested, retained sales vouchers and relevant information provided by the State; information should also be archived for the first-time supplying units of which they should be sought:

(i) A licence for the production of an enterprise for the production of a medical device or a copy of a licence for the operation of a medical facility and a copy of the business licence, which is the first medical agent in the List of Medical Agents, is required only to request a copy of the licence;

(ii) A certificate of registration of medical equipment and a copy of the medical certificate;

(iii) Authorization for the sale of medical equipment in the supply unit;

(iv) The effective identity of the salesr is evidence of the reproduction.

The business and use unit of the medical equipment shall be retained in accordance with the sale certificate and information required by this article, and shall be retained for a period of effectiveness or use of medical equipment for a period of one year, without less than two years.

Article 20, the procurement of medical equipment by a medical company and a unit, should be established and implemented in the delivery inspection inspection system, the identification of qualified certificates and other markings for the identification of medical equipment, and the non-requidition of the requirement.

The purchase of medical equipment by medical operators and using units to purchase medical equipment must be well documented and the procurement inspection record should be confirmed by the signature of the experienced collector.

Article 21 Medical equipment for the production of enterprise sales medical equipment shall open a sales certificate indicating the name of the purchase unit, the name of the medical device, the product registration certificate, the specifications, quantity, prices, production plants, production plants or product numbers, and add chapter.

The sale of medical equipment in the second and third categories of medical equipment in the List of Medical Agents is to be obtained by a sale certificate indicating the name of the purchase unit, the name of the medical equipment, the product registration certificate, the number, price, producer, production factor or product number, and by a seal.

The production of medical equipment, the operation of a medical facility must be well documented.

Article 2 Medical equipment purchases, sales records should include references to the name of the medical device, the specifications, the production of the number or the number of products, the period of effectiveness, the date of production, the product registration certificate, the purchase unit, the number of purchases, the purchase price and the date of the purchase. Unbranted medical workers must indicate the date of bacterial elimination and the bricket.

Medical equipment procurement receipts, sales records should be maintained for more than one year of the product's effectiveness or use of one year, but not less than two years; a one-time procurement receipt, sale record should be maintained for two years than the product's effective date; and the acquisition of vegetation medical equipment, and the sale of records should be permanently preserved.

Article 23 Production, operation and use units of medical equipment shall be stored in accordance with the requirements of the product standards and statements, the transport of medical equipment, and the establishment of a record of the destruction of medical equipment.

The production, operation and use of medical equipment may commission the storage, transport products that are capable of guaranteeing the quality of medical equipment.

Article twenty-four units for the use of medical equipment should be provided with the following conditions for the use of medical equipment to perform such acts as medical treatment:

(i) Sound management of the use of medical equipment;

(ii) Facilities, equipment and sanitation conditions consistent with the requirements of medical equipment;

(iii) technicians adapted to the use of medical equipment;

(iv) Other conditions under the law, regulations.

Article 25

(i) The name of the patient, sex, age, place of residence, communication addresses, contact phones, illnesses, time of operation, medical doctors;

(ii) Names of products, registration certificates, product numbers, specifications, date of production, production and duration;

(iii) Production of enterprise name, registration address, production address, and production of enterprise licences;

(iv) The name of the supply unit and its licence number.

The user requests the record of the use provided in the preceding paragraph, and the medical devices should be provided.

Chapter IV Oversight management

More than 26 per cent of the food drug surveillance authorities should establish a system for monitoring the daily inspection, verification, screening and testing, and to strengthen monitoring of the flow of medicines, medical equipment.

More than sanitary surveillance authorities should establish a security credit management system for the quality of medicines, medical equipment production, business and use units, record violations of quality safety credits by pharmaceuticals, medical equipment production, business and use units, and make public disclosure of the violation units.

Article 27 pharmacies and users of pharmaceuticals, medical equipment and equipment should conduct a health check every year and establish a health file. Medicines, medical operators and use units shall not arrange persons with infectious diseases or other diseases that may be contaminated with drugs, sterilized medical devices, and engage in direct contact with medicines, sterilized medical devices.

Article 28

Medicines, medical equipment production enterprises should be called back without the initiative to re-recruit medicines, medical equipment, and the Government's food medicine surveillance management should be compelled to return immediately; if necessary, pharmaceuticals, medical equipment production, business and use units should be required to immediately stop the sale and use of the medicine, medical equipment.

The twenty-ninth pharmaceutical, medical-arm operators and use units have found that they operate, used medicines and medical equipment are safely hidden and may cause damage to human health and life safety, and that the sale or use of the medicine, medical equipment should be stopped immediately, while notifying pharmaceuticals, medical agents to produce businesses or suppliers of goods and reporting to the host food drug control management authorities.

Article 33 Problem of medicines, medical devices produced in the province should be approved by the Ministry's Government's Food Medicine Monitoring Administration; the publication of drug advertisements produced in outside provinces should be made available to the Government of the Provincial People's Government for food medicine surveillance management.

The provincial Government's food medicine surveillance management should make the use of medicines, medical devices for the approval and filing of cases, for public inquiries, supervision and for the timely processing of the provincial Government's business administration.

More than thirty-first food drug control surveillance authorities should monitor drug, medical and equipment advertisements in the current administration area, advertise medicines, medical devices in cases where they have not been granted or are inconsistent with the approval content, and should be transferred in a timely manner to the same level of business administration.

Article 32 provides for arbitrary expansion of product adaptation (functional owners), absolute exaggeration, serious deception and misleading consumer medicines, medical devices in violation of the law, and that the Government's food medicine surveillance management should take administrative measures in accordance with the law to suspend the sale, use and use of the pharmaceutical, medical equipment within the jurisdiction of the territory, and that companies that are responsible for the publication of unlawful advertising should issue corrections on the ground. After the publication of an offence advertisement, the provincial authorities should take decisions to remove administrative coercive measures within 15 working days, upon request, by issuing corrections.

In the case of medicines, medical devices, which violate the legitimate rights and interests of consumers, companies that publish unlawful advertisements should be held civil responsibility under the law.

Article 33 pharmacies and use units implement government pricing, government guidance or market adjustments in accordance with the prescribed minimum tender price. Violence and damage to prices of drug users are prohibited.

Medical institutions that should be pooled in the procurement of medicines in accordance with the law should be subject to tendering, and should participate in the pooling of pharmaceuticals to reduce the prices of medicines. Other health agencies are encouraged to participate in drug-focused procurement activities.

The price authorities should make public to society the price of medicines that are subject to government pricing and government guidance, strengthen daily oversight inspections, and promptly identify price violations.

More than veterans of food medicine surveillance management should be transferred in a timely manner to the same-level price authorities in cases of alleged drug price violations.

More than 34 provinces should strengthen the e-net surveillance and system-building of the flow of medicines and medical equipment to promote information management of the drug and medical devices.

Drugs and medical equipment production, business and use units should establish a computer management system for the operation of medicines and medical equipment, the use of information, the timely import of pharmaceutical and medical equipment for the procurement, sale, use of information, and the supervision of the food medicine surveillance management.

Drugs and medical equipment information and transaction services through the Internet should be adhered to national legislation, regulations.

More than XV food drug surveillance authorities should establish a network of monitoring for the availability and quality of rural medicines, strengthen the regulatory management of rural drug markets and guarantee the quality and use of rural medicines.

In more than XVI, more than veterans of food-continent surveillance management should make public reports of telephone calls at a significant location of pharmaceuticals, medical devices and units.

Citizens, legal persons or other organizations have the right to lodge complaints, report to the management of food medicine surveillance over the district. More than veterans of food medicine surveillance in the district should be dealt with in a timely manner in accordance with the law; complaints, reporting matters are not covered by this sector and should be transferred to the relevant sectors and to inform the complainant, the reporting person.

Chapter V

Article 37, in violation of article 7, paragraph 2, of this scheme, provides that the production of medicines, the sale of medicines by the manufacturer of the manufacturer to the non-legally qualified drug-using units, is redirected by the management responsible for the supervision of the foodstuffs in the district and is subject to a fine of up to 3,000 dollars.

Article 33 is one of the following cases, which is being retroactive by the authorities responsible for the supervision of food medicines in more than 1,000 dollars:

(i) In violation of article 8, paragraph 1, of the present approach, the drug use unit has not been requested, retained vouchers and relevant information provided by the State;

(ii) In violation of article 9, paragraph 2, of the present approach, there is no authentic record of the receipt of the purchase of the pharmaceutical use units;

(iii) In violation of article 12, paragraph 1, of the present approach, drug use units are not authorized to store and transport medicines;

(iv) In violation of article 23, paragraph 1, of the scheme, medical equipment production, business and use units are not authorized to store, transport medical equipment.

Article 39, in violation of article 17 of this approach, provides for the sale of drugs by drug users units or the sale of drugs by means of an order of responsibility, warning, and a fine of up to 3,000 dollars for the sale or sale of pharmaceutical products.

Article 40 is one of the following cases, which is being corrected by the management responsible for the supervision of food medicines in the district and which is subject to a fine of up to $20,000 in the year 2000:

(i) In violation of article 16 of this approach, the pharmacies, pharmacies or pharmacies established by medical institutions are not in accordance with the conditions established;

(ii) In violation of article 24 of this approach, medical equipment use units do not have conditions for the use of medical equipment for medical treatment;

(iii) In violation of article 27 of this approach, pharmaceuticals, medical operators and use units do not carry out annual health inspections, arrangements for persons suffering from infectious diseases or other diseases that may be contaminated with drugs, sterilized medical devices, and engage in direct access to medicines, sterilization.

Article 40 is one of the following cases, which is redirected by the management responsible for the supervision of food medicines in the district and which is subject to a fine of more than 30,000 dollars:

(i) In violation of article 19, paragraph 1, of the present approach, the enterprise and use units of medical equipment are not requested, retained vouchers and relevant information provided by the State;

(ii) In violation of article 21, paragraph 1, and paragraph 2, of the scheme, the production of medical equipment and the absence of a sale certificate from the business enterprise;

(iii) In violation of article 20, paragraph 2, and article 21, paragraph 3, of this approach, which provides that medical equipment is produced, operated and used in units that are not authenticly complete in the acquisition, sale of records;

(iv) In violation of article 25, paragraph 1, of the present approach, the medical equipment use units are not established and permanently preserved the record of the use of imported medical equipment.

Article 42 (2) Abuses of authority, provocative fraud, malfeasing of work in the control of the flow of medicines and medical equipment, and depriving of duties by law, which constitutes a crime, are criminalized by law.

Article 43 violates the provisions of this approach, which are regulated by law, legislation and regulations.

Annex VI

Article 44, para.

Article 42