(Adopted at the 4th ordinary meeting of the People's Government of Land, 25 March 2011, by Order No. 4 of 29 March 2011, by the People's Government Order No. 4 of 2011, published as from 1 May 2011)

Article 1 ensures the effective use of arms in order to ensure human health and life safety, in accordance with the National People's Republic of China's Drug Management Act, the special provisions of the Department of State for the strengthening of the safety of products such as food, the implementation regulations of the National People's Republic of China's drug management law, the regulations governing the supervision of medical equipment and the regulations governing the regulation of the supervision of the disease.

Article 2

Medical institutions referred to in this approach include hospitals engaged in disease diagnosis, treatment activities, health clinics, therapy, clinics, health clinics (rooms), gynaecology, stations, community health services centres ( stations) and first aid stations.

Article 3 regulates the supervision of pharmacies in the city, the district food drug control monitoring authorities (hereinafter referred to as the food drug control regulatory sector).

The relevant sectors of the city, the people's government should be able to monitor the management of medical institutions within their respective responsibilities.

Article IV. Medical institutions should establish or be equipped with the quality management or quality management of the drugs that are adapted to their scale, to clearly manage their responsibilities and be responsible for the quality of the force.

Article 5 provides for the establishment of pharmacies or pharmacies by medical institutions. The regulation of pharmacies provides that the municipal food medicine control sector will be developed with the urban health sector.

Article 6. Medical institutions should actively integrate the acquisition, storage and use of pharmacies into management tele-management systems, in accordance with national, provincial and municipal provisions.

Article 7. Persons engaged in the management of the quality of medicines (hereinafter referred to as pharmacists) within medical institutions shall be strictly enforced in accordance with the provisions of Articles 7, 9, 10, 15 and 15 of the Act on the Control of Medicines and Medical Equipment in the State of the Interior.

Article 8. Medical institutions should purchase pharmacies from enterprises that have legal arms production, operational qualifications, and be able to test the qualifications of the pharmacies and establish a normative supply file; basic drugs should be obtained from the centralized procurement of essential drugs, and the delivery of the licensee.

Article 9

(i) A copy of the licence of the supplier;

(ii) Reprinted copies of the ex-clinical pharmacies in the urban food medicine regulatory sector;

(iii) Accreditation of the manufacturer's pharmacies, and a copy of the authorization of corporate legal persons;

(iv) Legal tax statements.

Article 10. Medical institutions should purchase drugs and should conduct quality inspections and establish a record of buying and authentic and complete medicine.

The pharmacization record is maintained for more than one year after the expiry of the use of the pharmacies, but no less than three years may be allowed; in that case, the acquisition of the veterans should be kept permanently.

Article 11. Medical institutions should establish relevant records for the installation, storage and transit of medical equipment, which will record one year after the release of medical equipment.

Medical equipment needed to be specializedly installed should be installed by the production plant or its authorized units with the qualifications of the services.

Article 12. Medical institutions should adapt to the scope of the treatment, and medical institutions such as the syllabus, the Clinic, the Village Health Service should not be equipped with medicines other than the regular use of drugs and first-aid medicines.

The acquisition and availability of medicines by family planning technology services should be consistent with the authorized range of services, service projects, operating articies and should not be equipped with medicines other than the basic pharmacies of the family planning technology services.

The basic pharmacies of the Family Planning Technology Service are developed by the municipal food medicine control sector with the urban population and family planning sectors.

Article 13 medical institutions should classify the acquisition of pharmacies in accordance with normative requirements and ensure the quality of the weapon in accordance with measures such as refrigeration, defence, stifling, ventilation, fire prevention, pests and rats, etc. Medical institutions must be kept on a regular basis for stockpiled pharmaceuticals.

(a) The destruction of the health sector should be reported in the custody inspection and use of suspected pharmacies or ex-pharmacies;

Article 14. Medical institutions should take effective means of preventive maintenance, testing and school supervision of equipment-based medical devices, and retain relevant data and records to ensure that medical equipment is in good condition.

Medical institutions should be based on the quality management of medical equipment.

Article 15. Medical institutions should redeploy medicines from the owners of the practitioners or practitioners' assistants, without any affordability.

Article 16 Medical institutions may not sell or sell drugs in a mail, falsification, counter-licensor's self-selection and diagnosis, sale, counselling, probationary, exhibition and other ways.

A medical facility may not be installed in private pharmacies or pharmacies.

Article 17

The combination of medicines requires the destruction of medicines for the least packagings, which should be kept in a piecemeal record and the retention of the smallest packaging and drug statements to be completed. After-stop drug packagings appear to indicate the names of medicines, specifications, use, use, quantification, duration of effectiveness and names of medical institutions.

Article 18 medical institutions should be equipped with the requirements of the Quality Management Guidelines for Psychiagents and to report on the distribution, use, storage and storage of medical equipment to the tele-management system in the food medicine control sector on time.

The medical body is not subject to advertising.

Article 19 Medical institutions should buy oxygen from pharmaceutical production companies that have obtained a licence for the production of medicines and a certificate for the quality management of medicines.

Medical institutions have self-changing oxygen and the equipment used should be registered with the medical equipment products and their production processes should be consistent with the relevant provisions and the quality of the production of oxygen is consistent with the standards of the People's Republic of China.

Article 20 Medical equipment developed by medical institutions should be produced or processed in accordance with the relevant quality management requirements, and a true and complete production or processing, use of records.

Medical equipment developed by medical institutions should be used in this unit and not sold to the market without unauthorized expansion of the scope of the manufacture of medical equipment.

Article 21, the use of intrusive medical equipment by medical institutions should be established and kept permanently. The record includes:

(i) The name, address, telephone;

(ii) The date of the operation, the name of the physician;

(iii) Names of products, specifications (phasitions), registration certificates, production plants, production kits (numbers or orders), articles, date of production and duration of effectiveness;

(iv) The supply unit, the date of acquisition, the address of the supply unit and the telephone.

Article 2 medical institutions shall not use non-registration certificates, non-qualified certificates, expires, invalidated or technically phased medical devices according to national provisions.

The use of medical equipment by medical institutions should be strictly carried out in accordance with the medical equipment product statement. Medical equipment that is marked by the use of a note or in-country packaging is prohibited by the use of a “pushing blocked or disappeared” warning, such as the opening or devastation of the packaging.

Article 24 Medical agencies should immediately stop use and report in a timely manner on the municipal food medicine control sector, if they have found that a statement of the use of medical equipment is exaggerated and falsely disseminated.

Article 25 Specific equipment used by medical institutions and the measurements included in the National Forced Quantification List should be used by the statutory screening body.

Article 26 Medical institutions should designate specialized personnel to follow up on the quality, therapy and adverse responses to the use of pharmacies in this unit, in accordance with the relevant national provisions. In cases where there may be adverse reactions or negative incidents related to drug use or armed use, reports should be made promptly to the food drug control regulatory sector, the health sector or the relevant testing sector.

Article 27 Medical institutions should strictly manage narcotic drugs, mental medicines, medical toxic medicines, medical use of radioactive drugs, hazardous chemicals and vaccines in accordance with the provisions of the legislation.

The Food Medicine Regulatory Service should strengthen the drug control monitoring and screening of medical institutions in the current administration area and should not collect any costs. In the course of the regulation of the food medicine sector and its staff, the persons concerned should cooperate actively and should not provide false information without denying and concealing them.

Article 29 is one of the following cases in the medical body, which is being converted to the time limit by the municipal, district-based food drug control control authorities, and has been fined by over 5,000 dollars:

(i) In violation of article 5 of this approach, the establishment of a pharmacological or pharmaceutical counter is not in accordance with the normative pharmacies;

(ii) In violation of article 6 of this approach, the acquisition, storage and use of pharmacies in the management remote e-regulation system is not provided for in the provisions;

(iii) In violation of article 19, paragraph 2, of this approach, the quality of oxygen produced or produced is not in accordance with the standards of the People's Republic of China pharmacies;

(iv) In violation of article 20, paragraph 2, of this approach, the scope of the use of medical equipment developed to markets or the unauthorized expansion of the development of medical equipment.

Article 33 is one of the following cases in the medical institutions, which are being corrected and fined by the urban, district-based food medicine control sector, with a fine of up to 20,000 dollars in the year 2000:

(i) In violation of article 10 of this approach, no purchase and acquisition of a receipt record and the record of the receipt of the receipt as prescribed;

(ii) In violation of article 11 of this approach, records relating to the establishment or retention of medical equipment;

(iii) In violation of article 15 of this approach, the transfer of medicines by no means;

(iv) In violation of article 18, paragraph 2, of the present approach, advertising of the medical body for the preparation of the agent;

(v) In violation of article 21 of this approach, vegetation medical equipment does not establish records or records incomplete;

(vi) In violation of article 26 of the present approach, there is no provision for reporting on ill-responses of medicines and ill-treatment of medical equipment.

Article 31 is one of the following cases in the medical institutions, which is being converted by the municipal, district-based food medicine control sector to the time limit, and which is overdue, with a fine of up to $50 million:

(i) In violation of article 8 of this approach, no supplier files are established;

(ii) In violation of article 13 of this approach, the failure to maintain a record of pharmacies or non-performance and the self-return, exchange of goods and destruction, as provided for in article 13 of the scheme;

(iii) In violation of article 14 of this approach, there is no record of the use of medical equipment or no file.

(iv) In violation of article 17, paragraph 2, of the present approach, there is no record of the destruction or of a statement of the least packaging and pharmaceuticals of the former, as well as the contents of the piecemeal pharmaceutical packaging, specifications, use, use, quantification, effective duration, removal of the name of the non-medical institution;

(v) In violation of article 24 of this approach, the regulatory authorities for foodstuffs have not been reported to be dealt with.

Article 32 contains one of the following cases in the medical institutions, which are sanctioned by the municipal and district food drug control authorities in accordance with the provisions of the People's Republic of China's Medicine Management Act, the Land Town Metrics and Medical Equipment from the Industrial Monitoring Approach:

(i) In violation of article 9 of this approach, no information was requested at the time of the purchase of a drug weapon;

(ii) In violation of article 12 of this approach, the provision or availability of medicines is beyond the scope specified;

(iii) In violation of article 16 of this approach, private pharmacies or pharmacies, or mailing, falsification, self-selection and diagnosis, sale, counselling, probationary, exhibition boards and other means of selling or distributing drugs;

(iv) In violation of article 19, paragraph 1, of this approach, no pharmaceutical-product production licences and the GMP certificate have been obtained to buy oxygen for medical purposes.

Article 33 Medical institutions have one of the following cases, which are sanctioned by the municipal, district-based food medicine control sector in accordance with the State Department's regulations on the regulation of medical equipment, the one-time use of non-benecotic medical surveillance methods:

(i) In violation of article 22 of this approach, the use of unregistered, unqualified, expired or phased medical devices;

(ii) In violation of article 23 of this approach, there is no strict enforcement of the norms governing the use of medical equipment.

In violation of article 27 of this approach, medical institutions do not strictly manage narcotic drugs, mental medicines, medical toxic medicines, medical use of radioactive drugs, hazardous chemicals and vaccines, which are dealt with by the division of responsibilities between the health administration and the food drug control authorities.

Article XV regulates the food medicine sector and the staff of its testing institutions in one of the following cases, which are administratively disposed of by law; constitutes an offence and are held criminally by law:

(i) The reports of the quality of the arms reported or medical institutions are not dealt with in a timely manner by law, resulting in adverse consequences;

(ii) The failure to launch emergency pre-release cases in a timely manner, resulting in adverse consequences, as reported by the incidents of ill-treatment of pharmacological groups;

(iii) Fee tests, test reports or fees charged in violation;

(iv) Participation in drug purchases;

(v) There are other abuses of authority, provocative fraud, and sterilization.

Article XVI provides for administrative review or administrative proceedings in accordance with the law by the parties with respect to the food drug control regulatory and related sectors.

Article 37 states that agencies and units engaged in disease prevention, diagnosis, treatment, health activities are implemented in the light of this approach.

Article 338 is implemented effective 1 May 2011.