Chapter I General

Article 1, in order to regulate the use of medicines, medical devices and to guarantee human health and life safety, sets this approach in line with the laws, regulations, such as the People's Republic of China's Drug Management Act, the Department of State Medical Asset Monitoring Regulation Regulations.

Article II applies to medical institutions within the province's administration, family planning technology services, blood stations, single-pulse pulses, rehabilitation support institutions (hereinafter referred to as the use units) and the use of medical equipment, as well as supervision by the regulatory authorities for their implementation.

Article 3. The use of units shall be in accordance with national provisions to establish a security responsibility for the use of medicines, medical equipment, in accordance with national provisions.

Article IV. Supervision of food drugs at the district level (hereinafter referred to as the pharmacies) is responsible for the management of surveillance in the area of medicine, medical equipment and weapons.

Sectors such as hygienic, price, business and quality should be responsible for the monitoring of drug use, medical devices, in accordance with their respective responsibilities.

Chapter II Procurement, receipt, inspection

Article 5 Use units should purchase medicines, medical devices from enterprises with medicines, medical equipment or operational qualifications. The acquisition of medical equipment that does not apply for the management of approval No.

Article 6. The use units shall designate an institution or a person to harmonize the procurement of medicines, medical equipment. Other bodies or persons may not be procured by themselves.

Article 7 procures pharmaceuticals, medical devices in the form of tenders, and use units should strictly implement the relevant provisions of the State and the province and receive oversight by the pharmacies and other relevant sectors.

Article 8

(i) A copy of the manufacture or operation of licenses and licenses, medical equipment produced or operated licenses, vouchers and business licences;

(ii) A copy of the certificate of certification for the production or operation of quality management standards;

(iii) A copy of the certificate of registration of a medical device or a written file;

(iv) A copy of the import certificate or the certificate of registration of pharmaceutical products;

(v) A copy of the drug test report, a certificate of eligibility for biological products, and a copy of the medical certificate of eligibility;

(vi) Original and photocopy of the authorizations of drug, medical and arms sales agents.

A copy of the information provided in the previous paragraph shall be added to the seals of the suppliers' businesses.

Article 9. When medicines, medical equipment and freight are delivered, the use units shall determine whether the means of transportation are met and whether the medicine, medical equipment is in compliance with the accompanying pyrethroids and the cheques.

When refrigeration, refrigeration of medicines, medical devices and freights are needed, the use of units should also identify quality control such as nuclear and record transport time, and temperature records of transport processes. It should be refused to meet the temperature requirement.

Article 10. The use of units to purchase drugs should be collected on a case-by-case basis, in accordance with the pharmaceutical column and to establish authentic and complete drug collection records. The data collection records should contain generic names of medicines, manufacturers, agents, specifications, production kits, effective periods, approvals, supply units, quantity, arrival date. The record of the collection of medicines should be signed by the recipients. Unqualified medicines should be processed in accordance with procurement contracts and relevant national provisions.

The use of units to receive donations of medicines and first-time medicines from other use units should be collected and recorded in accordance with the preceding paragraph.

Article 11. The use of units for the acquisition of medical equipment should be carried out and the establishment of authentic and complete medical equipment receipt records. The receipt records should contain the name, specifications, stereotypes, quantity, production orders, periods of effectiveness, production plants, supply units, relevant licences or supporting documents, and the date of delivery, etc.; and the date of the removal of bacterial medical equipment should also be recorded or extinguished. The receipt records should be signed by the recipient. The experience of collecting non-qualified medical devices should be addressed in accordance with procurement contracts and relevant national provisions.

The use of units externally requests medical equipment taken by doctors, medical equipment accepted for donations, which should be tested and recorded in accordance with the preceding paragraph.

Article 12 For more than three years of effectiveness, the receipt record is maintained for one year after the expiry of the effective period.

The medical check-up records should be maintained for two years after the expiry of the period of use by medical equipment or two years after the termination. Large-scale medical check-ups should be kept up to five years after the expiry of the period of use of medical equipment or five years after the termination. The record of the admission of medical equipment should be kept permanently.

Chapter III

Article 13 places, facilities, conditions and conditions for the storage of medicines, medical equipment, should be in line with the requirements for storage of stocks of medicines, medical devices and relevant national provisions. The pharmacies using units should be in line with national and provincial drug management norms.

Article 14. The use units should conduct regular inspections of stored medicines, medical equipment, and monitor the temperatures and humidity of storage medicines, medical equipment. Inspections, monitoring should be recorded.

The use of units should be immediately sealed, registered and processed in accordance with the relevant provisions.

Article 15. The use unit shall, in accordance with the statement of product, inspect, test, calibration, maintenance and maintenance, establish a check, test, school quasi, maintenance, maintenance and maintenance record on a case-by-case basis.

After schools, maintenance, maintenance and maintenance, they still do not have medical equipment categories that use safety standards, the use of units must stop and be processed in accordance with the relevant provisions.

Chapter IV

Article 16 shall be used by a user unit within the framework of the medical treatment subject approved by law or the services project.

Article 17 should use units to redeploy pharmaceuticals in line with prescriptions. It should be assumed by persons who are eligible for pharmacical technical functions.

Article 18 Persons who are directly exposed to medicines and medical equipment should be subject to health inspections every year. In the case of infectious diseases or other potentially contaminated medicines, medical equipment or diseases, there shall be no direct access to medicines, medical devices.

Article 19 Use of units for therapeutic distribution, facilities, packaging materials and containers, working environments should be in line with quality and sanitation requirements.

The use of units for the internal distribution of medicines and the destruction of spare parts for the least packaging of medicines should indicate the time for the destruction of spare parts, the name of medicines, specifications, allies, use, quantity, use, duration and effectiveness. The storage of medicines should be consistent with the storage requirements of the original packaging mark. The destruction of piecemeal medicines should be recorded.

Article 20 should follow up on the use of vegetation medical devices and establish records.

Information on the use of vegetation types of medical equipment, the name of the patient, the hospitalization, the duration of the operation, the name of the physician and the name of the veterans, the specifications, the number of products or orders, the product registration certificate, the production plant and the supply unit should be included in the record file. The records should be maintained in conjunction with the medical file and the return record.

Article 21 transfers, donations of medical equipment in a condition of use, the transferee, the donor shall ensure the security and effectiveness of the transfer, the donation of medical equipment, the provision of legal documentation, product statements, and the transfer of medical equipment during the use of the equipment.

Transfers, donation of medical equipment can be used by a qualified inspection body to test qualifications and by the dispersed and grantee, in accordance with article 11 of this approach.

Article 22 Use units should monitor, report poor responses to medicines and incidents of ill-treatment of medical equipment in accordance with relevant national provisions.

The use of units found that their use of drugs, medical equipment was safe and could cause damage to human health and life safety, should be stopped immediately, reported to the pharmacies and informed of the production and operation of enterprises.

Oversight inspection

Article 23. The pharmacies should conduct monitoring inspections of the following matters for the use of units and the use of units should not be denied and concealed if they are provided in practice and corresponding information:

(i) The establishment and implementation of drug, medical equipment management systems;

(ii) Management of pharmaceuticals, medical equipment procurement files, receipt of nuclear records, inspection records, storage inspection monitoring records and drug dispersion records, and vegetation of medical equipment;

(iii) The storage, maintenance, mediation and use of medicines, medical equipment.

The pharmacies can conduct a sample of pharmaceuticals, medical equipment and equipment using units, depending on the need for monitoring inspections. Use units should be synchronized.

The health-care sector should monitor the use of unit medicines and medical equipment, in accordance with the National People's Republic of China Drug Management Act and the relevant legislation, regulations.

The price sector should monitor, in accordance with the law, the fees for pharmaceutical prices, medical equipment prices and the use of medical equipment for the use of units, and identify the offences of drug prices, medical equipment prices and medical equipment services.

The business sector should monitor the advertisements of the use unit in accordance with the law and identify the offences of the publication of medicines, medical devices.

In accordance with the provisions of the Law on the Safety of Specialized Equipment of the People's Republic of China, the quality sector should monitor the security of medical equipment used by the use of units in the form of mandatory inspection kits, in accordance with the provisions of the law, regulations and regulations of the People's Republic of China Measuring Act.

Sections such as pharmacies, sanitary birth, price, business and quality should be kept under this approach. The oversight of the inspection records should be archived by the supervision of the inspectors. The public has the right to access the inspection records.

Monitoring findings should be made available to society in a timely manner, either on the website of the sector or in other public-friendly ways.

Sections such as pharmacies, sanitary birth, price, business and quality should be made available to the public in a manner that informs complaints and reports of telephones in this sector. Complaints and reports received should be promptly investigated, processed in accordance with the law or transferred to the competent authorities to investigate and address them in accordance with the law. The results of the investigation, treatment should be communicated to the complainant or to the author in due form.

Article 27 pharmacies should establish a credit management system for the use of medicines, medical equipment, which is in violation of this approach by law and by means of disclosure.

The pharmacies should establish emergency preparedness cases for the use of safe emergencies for medicines, medical devices. In the event of a sudden incident, the pharmacies should launch emergency preparedness.

Chapter VI Legal responsibility

Article 29 contains one of the following cases, which are being corrected by the pharmacies and warnings; and is not reformulated, with a fine of €50 million above 2000.0:

(i) The establishment of a drug, medical and equipment procurement file, in accordance with article 8 of this approach, without relevant information on the identification, request for procurement, medical equipment;

(ii) No drugs, medical equipment or equipment that are nuclear to be inspected pursuant to article 9 of this approach;

(iii) Unless access to medicines, medical equipment is provided for in Articles 10, 11, 12 of this scheme, the collection of the receipt and the preservation of the receipt records;

(iv) No treatment of medicines and the dismantling of piecemeal medicines, as provided for in article 19 of this approach;

(v) No follow-up record of the use of intrusive medical devices pursuant to article 20 of this approach, the establishment of records and permanent preservation.

Article 30 provides that, in violation of article 5 of this scheme, the acquisition of medicines, medical devices from enterprises that do not possess medicines or medical equipment for the production, operation, is converted by the pharmacist service and is subject to a fine of more than five times the value of the purchase of medicines, medical devices.

The use of units to purchase drugs, medical equipment from a super-managed approach or a super-managed enterprise is being warned by the pharmacist service for a period of time and warning; the refusal to reproduce, with a fine of 5,000.

Article 31 does not provide for the harmonization of the procurement of medicines, medical devices or personnel by designated institutions or personnel under article 6 of this scheme, which is subject to a warning by the pharmacological order, and rejects the correctness of a fine of up to $100,000.

Article 32 does not provide for the storage of medicines, medical equipment, in accordance with article 13 of this approach, and is being warned by the pharmacist sector for the period of time being converted to a warning; the refusal to reproduce, with a fine of more than 300,000 dollars.

The use units do not provide for the conservation, maintenance of medicines, medical equipment, as prescribed by article 14, article 15 of the present approach, and are warned by the pharmacist sector for a period of time; the denial of correction; and the imposition of a fine of €50 million.

Article 33 contains one of the following cases, which are punishable by the Pharmaceutical Service in accordance with the provisions of the National People's Republic of China Act on the Control of Medicines in the People's Republic of China.

(i) The unauthorized acquisition and use of other medical institutions for the preparation of preparations;

(ii) Referral, probationary marketing of medicines, medical devices;

(iii) Use of non-qualified documents for medical equipment;

(iv) In violation of article 21 of this approach, the receipt, use or donation of medical equipment.

There are one of the following cases for staff in the pharmacies and other relevant departments, which are lawfully disposed of by law; those suspected of constituting an offence are prosecuted by law:

(i) Complaints against the use of medicines, medical devices, reports of non-legal investigations and treatment;

(ii) The sale of medicines, medical devices to use units;

(iii) To recommend medicines, medical devices to the use unit;

(iv) Failure to perform oversight duties or to detect violations in the supervision of the inspection, which is not lawful;

(v) Other acts of negligence, abuse of authority, favouring private fraud.

Chapter VII

Article 55 of this approach is implemented effective 1 April 2016.