(Adopted at the 10th ordinary meeting of the Government of the city on 30 March 2009, by Order No. 139 of 30 March 2009, to be published as from 1 May 2009)

Article 1, in order to strengthen the management of medicines and medical equipment, ensures the effective safety of human use of medicines and medical equipment, and in accordance with the laws, regulations and regulations such as the People's Republic of China Pharmaceutical Medicine Management Act, the Medical Assurance Regulation Regulations.

Article 2 units and individuals involved in the production, distribution, operation, use and supervision of pharmaceutical and medical equipment in the present municipal administration should be subject to this provision. The law, legislation and regulations provide otherwise, from their provisions.

Article 3 provides for the supervision of drug and medical equipment in the current administration.

The municipal, district quality technical monitoring services include the production, use and supervision of medical equipment in the catalogue of the management and enforcement of the measures.

The relevant sectors of the city, the people's government should be monitored in accordance with their respective responsibilities.

Article IV. When a pharmaceutical-producing enterprise produces pharmaceutical products, a medical agency is equipped with the purchase of raw materials and supplemental materials, a copy of the Business Licence, a product qualification certificate and a product invoice should be requested to the supply unit.

The following documents should also be requested, in addition to the evidence provided in the previous paragraph, when pharmacies and pharmacies must be obtained:

(i) Complete copies of the Pharmaceutical Production Permit or the pharmaceutical operation licence;

(ii) The Guidelines for the Quality of Medicine Production, or the certified copies of the Standards for the Quality Management of Medicines;

(iii) The approval of pharmaceuticals in the form of a sealed chapter of the Géguétat;

(iv) Authorized letters of authorization to authorize the sale of goods, territories, time limits, and to indicate the number of licensees; authorizations are photocopy and should be added to the original seal of the supply unit and the original chapter or signature of the enterprise representative;

(v) A copy of the owner's identity card;

(vi) A sales certificate containing elements such as the pharmaceuticals;

(vii) Other relevant documentation to be requested by law.

The above-mentioned documentation requested should be retained for one year after the expiry of the period of effectiveness of the raw materials, backed by the material, and three years should be preserved for an effective period of up to two years.

Article 5 prohibits the use of opioid raw materials that are not in compliance with national standards, supplemented by the production of medicines, consignments.

The prohibition should mark an effective period without identifying or exceeding an effective period of pharmacetic raw materials, complement the production of medicines, consignments.

Article 6. Production of medicines must be made in accordance with the prescriptions and prescriptions set out in national drug standards, and in accordance with the production process approved by national food drug control monitoring authorities.

Article 7.

Article 8.

Article 9 prohibits the sale of medicines by a pharmaceutical-producing enterprise and a licensee to a unit and individual free of a pharmaceutical production permit, a licence for the operation of medicines, a licence for the operation of a medical institution.

Article 10 The second category of medicines, medical equipment operators and national provisions, three types of medical equipment should be provided with quality tests and complete authentic and complete receipt records.

The record of the collection of medicines shall not exceed three years. More than three years of effectiveness of medicines, the record of the collection of medicines has been kept for one year after the expiry of the period of effectiveness.

The medical check-up record should be kept for one year after the expiry of the period of operation or the cessation of the use, but no less than three years must be kept. The inspection records of vegetation medical equipment are kept in the same period as their quality tracking.

Article 11. The retail enterprises of medicines, the tools used by medical institutions to dismantle the sale of medicines, the packaging kits should be clean and sanitation, and the sale of medicines should be made available in the drug kits, specifications, kits, uniforms, use, effective periods.

Article 12 prohibits the leasing of a pharmaceutical enterprise; prohibits the release of the same medicines by a different counteror or by the cargo company in the same place of operation; and prohibits the retailing of medicines from placing goods other than the pharmaceutical counter, the shipment of drugs.

Article 13 prohibits the illicit acquisition of medicines.

The production of medicines and the operation of the enterprise could be engaged in public-health-recovery drug activities, but it should be reported to the authorities for the surveillance of locally recovered food medicines before the start of recovery activities.

Food drug surveillance management should monitor the whole process of recovery to destruction.

More than XIV (condominant) medical institutions should establish relatively independent drug and medical equipment warehouses adapted to their scale.

Specific management approaches are developed by the municipal food medicine surveillance authorities.

Article 15. The establishment of a cell within a medical institution must use medical institutions to harmonize the acquisition of medicines; to buy the drugs on their own hands and to deal with the use of undocumented medicines.

Article 16 advertisements, promotional information and internal training materials, written statements, labels, statements, packagings etc., signs of adaptation or functional ownership of medicines beyond the scope of the national drug standards, which are treated on the basis of a sales counterfeit.

Non-drug advertisements, promotional information and internal training materials, written statements, labels, statements, packagings, etc. contain elements such as drug adaptation, functional ownership, use of law and use, and are treated under the sale of false medicines.

Article 17 Medical equipment for the production of medical equipment for enterprise production, and in the acquisition of raw materials and parts, a copy of the Business Licence, a product certificate of eligibility and a product invoice should be made available to the supplier unit for approval.

The acquisition of raw materials, the parts of the pipeline are included in the management of the licence, and, in addition to the confirmations provided in the previous paragraph, requests should also be made for the reprinting of the Medical Agent Production Business Licence or the Medical Asset Business Licence of the Medical Agents, as well as the copy of the Medical Accreditation of the Medical Accreditation of the Carriage Unit.

The acquisition of raw materials, parts belonging to non-bacterial products should be preserved for one year after the expiry of the product's effectiveness; there should be no effective period to preserve or stop the sale of the product for three years after the sale of the product or the sale of the country's priority products, such as vegetation and the intervention category, confirm that the document should be permanently preserved.

Article 18 prohibits the sale, storage and storage of the second category of State-mandated premises, storage outside the warehouse, and three types of medical equipment.

Article 19 Production of medicines and medical equipment and business enterprises should organize regular training of practitioners on the appropriate expertise and legal knowledge.

The production of medicines and the operation of business practitioners should be eligible for corresponding vocational skills in accordance with national provisions. Vocational skill qualifications training is carried out by the Food Medicine Monitoring Administration and the labour sector is responsible for the conduct of inspections and the production of a national uniform vocational qualifications certificate.

Article 20 Production, operation and medical institutions of medicines and medical equipment should organize health inspections and health files for persons who are directly exposed to drugs and sterilics.

Persons who do not carry out health inspections and communicable diseases and other diseases may contaminated medicines and sterilized medical devices are prohibited from engaging in direct access to medicines and sterilized medical devices before they are treated or excluded.

Article 21 publishes advertisements of false medicines, medical devices and is governed by laws, regulations and regulations administered by the business administration.

Article 22 provides for the seizure and seizure of medicines in one of the following cases:

(i) The National Food Drugs Monitoring Administration provides for the prohibition of use;

(ii) The sale, distribution, operation, import, or inspection shall be carried out without the approval of the production, distribution, distribution, use, without the authorization of the production, distribution, operation, import or inspection;

(iii) The use of pharmacies that do not obtain approval;

(iv) The reference to adaptation or functionality beyond the specified scope;

(v) It should be noted that no period of effectiveness or modification of the period of effectiveness should be indicated;

(vi) No reference to or modification of production orders;

(vii) Continuation of operation and use over an effective period;

(viii) Package materials and containers that are directly exposed to drugs are not approved;

(ix) The unauthorized addition of opioids, anti-corruption agents, foams, correctional agents and accompanying materials;

(x) A supplemental material for the production, distribution and use of medicines is not in accordance with the drug standards;

(xi) No production of the approved production process in accordance with the criteria or in accordance with the approved criteria;

(xii) Processing without a licence;

(xiii) Excluding the production, distribution or operation of the licence;

(xiv) Production, non-production or distribution of records, in-householding or sale records, and in-householding of retail operations;

(xv) Other pharmaceuticals that may endanger human beings under the laws, regulations.

In violation of this provision, the purchase of pharmacies for raw materials and the need to obtain pharmacies for the approval of pharmacies are accompanied by a failure to request and maintain one of the documents in article 4, paragraph 2, subparagraphs (i), (iii), (vi) of the present provision, which amounts to less than 5,000 dollars for the purposes of confiscation of proceeds of the law by food medicine, the supervision of management, and a fine of up to $20,000 for the amount of €50 million, and a fine of more than €10,000, or more than 100,000 for the purpose of the offence.

The purchase of pharmacies for raw materials and the need for pharmacies to obtain and preserve one of the supporting documents of article 4, paragraph 2 (iv), (v), of this provision, is subject to correction and warning; and is not later corrected, with a fine of up to $200 million.

Article 24, in violation of article 5 of the present article, uses pharmaceutical material that is not in accordance with national standards, supplemented by the use of pharmacies containing raw materials that are not valid for an effective period or exceed the period of time, the supplementary production of medicines, the preparation of the manufacturer, the confiscation of proceeds of the law by the Food Medicine Supervision Administration, the amount of which is less than 5,000 and the fine of $20,000, and the amount of €50 million for the goods, and the amount of more than €1 million, and the amount of the excess of the proceeds of the offence.

Article 25, in violation of article 6 of the present article, has not been surrendered in accordance with the State drug standards by side or by side, without the production of medicines approved by the National Food Drugs Supervision Authority, by the confiscation of proceeds and products in violation of the law by the Food Medicine Regulatory Authority of the amount of less than $50 million, with a fine of $50,000; the amount of goods of less than 5,000 and a fine of $100,000; the amount of goods of more than 1 million, and the amount of more than 10 times the amount of the excess of the amount of the authorized by the law.

Article 26, in violation of article 8 of the present article, criminalizes the acquisition of medicines by pharmaceutical-producing enterprises, pharmaceutical operators, medical institutions from pharmaceutical retail enterprises or the acquisition of medical institutions.

Article 27, in violation of article 9 of the present article, provides that a pharmaceutical-producing enterprise and a consortium sells drugs to units and individuals without a pharmaceutical production permit, a licence for the operation of medicines, a licence for the operation of the medical institution, a warning and a fine of US$ 1 million; and, in exceptional circumstances, a fine of $2 million.

Article 28, in violation of article 10 of the present provision, purchases of medicines, medical equipment operators into the second category of medicines and national provisions, three types of medical equipment are not subject to quality tests, with no authentic record of receipts, the receipt of the record is not kept at the time specified, and is being converted by the food medicine surveillance management order, warnings and fines of more than 500,000 dollars.

Article 29, in violation of article 12 of the present article, the retailer of the pharmaceutical industry has placed the same medicine in the same operating place or other commodities other than the pharmaceutical counter, the cargo loading of medicines, with a fine of 1000 dollars from the Food Drugs Supervision Administration; in the case of serious circumstances, the fine of up to 5,000 dollars.

Article 31, in violation of article 13, paragraph 1, of the present article, unlawful acquisition of medicines, is punishable under article 73 of the People's Republic of China Drug Control Act.

Article 31, in violation of article 14, paragraph 1, of the present provision, does not establish relatively independent drug and medical equipment warehouses that are adapted to their scale, and is subject to warning by the food drug surveillance management for the period of time and by fines of up to 5,000 dollars after the delay.

In violation of article 17, paragraph 2, paragraph 3, of the present article, the manufacturer of medical equipment is subject to the acquisition of raw materials, parts of the licence management, which are not required to request and maintain the relevant documentation, with a fine of up to 1 million dollars for the Food Drug Control Management Service.

Article 33, in violation of article 18 of this provision, sells, stores a second category of State-mandated by food medicine surveillance authorities, three types of medical equipment, stops the operation by a food-medical surveillance authority, confiscation of products and proceeds of the conflict, proceeds of the offence, exceeds 5,000 dollars of the proceeds of the offence, and makes up more than five times the penalties for the proceeds of the violation; does not receive less than 5,000 proceeds of the offence or pay less than €50 million for the offence; and constitutes criminal liability under the law.

In violation of article 19 of this provision, the production of medicines and medical equipment, the training of practitioners who operate without a regular organization for training in expertise and legal knowledge, allows persons who do not have the corresponding vocational skills to be employed and are warned by the time limit of the food medicine surveillance management order; the imprecise changes that have been delayed, with a fine of up to $200 million.

In violation of article 20 of this provision, pharmaceutical and medical devices are produced, operated and medical institutions do not organize direct access to medicines and sterilized medical personnel, in accordance with the provisions, and allow for unhealthy inspections and treatment of persons with infectious diseases and other diseases that may be contaminated with drugs and sterilics or exclude the work of direct contact with medicines and sterilized medical devices prior to the possible contamination, and are subject to correctional orders from food-monitoring authorities, warnings and fines of up to $50 million.

Article XVI Oversight managers of food medicine do not perform their duties seriously, abuse of their duties, provocative fraud, and malfeasing, are administratively disposed of by this unit or by the inspectorate in accordance with the relevant provisions; constitute a crime and hold criminal responsibility under the law.

Article 37