(Adopted by the 16th ordinary meeting of the People's Government of New York on 17 December 2012 No. 200 of the Order No. 200 of 21 December 2012 No. 200 of the People's Government Order No. 0 of 21 December 2013, effective 1 February 2013)

Chapter I General

Article 1 regulates the operation order of medicines to ensure the quality of medicines and the safety of medicines, in line with the laws, regulations, such as the People's Republic of China's Drug Management Act, the People's Republic of China's Drug Management Act.

Article 2

Article 3 is responsible for monitoring the management of pharmaceutical operations in the present administration, in both urban and district (market) drug control authorities.

The administrations such as business, health and transport are responsible, within their respective responsibilities, for monitoring the management of pharmaceutical operations.

The commune government and the street offices should assist food drug surveillance authorities in the supervision of the operation of medicines in the Territory.

Article IV. Pharmaceutical industry associations should strengthen industrial surveillance and act as a self-regulatory role to promote the operation of the pharmaceutical industry by law.

Chapter II

Article 5 operates a pharmaceutical enterprise that should be in accordance with the conditions laid down by law, regulations and procedures such as administrative licences, business registration.

Article 6.

Article 7.

Article 8. Due to the need for operational management to adjust the area of the drug operation and the base, the operating conditions should not be reduced and the food drug control surveillance management case should be reported within 15 days of the adjustment.

Article 9. The pharmaceutical operation commissioned pharmaceutical logistics companies to undertake drug transport or storage operations and should be responsible for the quality safety of medicines during transport or warehousing. For the transport or warehousing of requested medicines, the pharmaceutical operation should promote logistics companies to take the necessary safeguards or refrigeration measures as required.

The pharmaceutical operation sends the drugs to the postal service or to the company's mail and should produce relevant material to demonstrate the legitimacy of the medicines; the postal business agency or the fast-moving company should be present.

The transport, storage, mailing of specially administered medicines, such as narcotic drugs, mental medicines, medical substances and radioactive drugs, should be carried out in accordance with the relevant provisions.

Article 10. The sale of non-headed medicines by pharmaceutical-produced enterprises can be transferred directly from pharmaceutical-producing enterprises or other pharmaceutical-producing enterprises to purchase businesses, subject to the qualifications of this enterprise quality manager and record-keeping.

Article 11. The manufacture of special medicines reproduces by pharmaceutical companies should establish customer files to verify and retain the purchaser's qualifications certificate of photocopy, a copyright and identity certificate of photocopy.

Article 12

Article 13. The acquisition of medicines by a pharmaceutical operation shall be lawful and shall be made in accordance with the provisions for the acquisition and receipt of a record; the statement is not in conformity with the relevant provisions or is not in conformity with the instruments, the accounts, the goods.

The accompanying medicines are accepted by the pharmaceutical industry when buying drugs, and should be suffice to demonstrate the corresponding evidence of the legal origin of the medicines and to receive them in accordance with the provisions.

Article 14.

Article 15. The retailer of medicines should implement prescriptions for the management of prescription drugs and non-subsidiaries, as prescribed by the sale of prescriptions.

Article 16 The sale of special pharmaceutical agents by the retailer of medicines should be registered in a prescribed capacity, and the sale should not exceed the number of provisions and should not be sold directly to minors.

Article 17, without the approval of the Health Administration, the retailer of medicines shall not carry out medical treatment activities in its premises. The drug sales area should be clearly physical segregation with therapeutic areas, as approved by the health administration.

Article 18

Article 19

The following products shall not be sold in the manufacture of drugs:

(i) A generic name, a commodity name or other named product that has been approved as a drug name;

(ii) Products such as diagnostic, treatment, mitigation or prevention for packaging, labelling, statements and related information;

(iii) The addition of products of the drug component in violation of the law.

Article 20

Article 21

Article 2

Article 23 Endowment of medicines by pharmaceutical operators should be made available to grantees, copies such as the pharmaceutical operation licence, the pharmaceutical approval certificate, the pharmaceutical production plant or the pharmaceutical testing report by the statutory agencies, and relevant information provided by the State.

The actual duration of the donated medicines cannot be less than six months.

Article 24

Chapter III

Article 25 The head of the pharmaceutical industry should be familiar with the legal, regulatory, regulatory and basic knowledge of the management of medicines and be responsible for the quality of the medicines operated by the enterprise.

Article 26 The quality management of the pharmaceutical operation and the medical laboratory personnel shall have a pharmacological or related professional education or a technical title of the pharmaceutical profession.

Subsidised persons in the retail industry of medicines should have higher professional technical qualifications.

Article 27 Quality management, testing, inspection, custody, maintenance, etc. staff members who operate pharmaceuticals should be given a certificate after a qualified examination by professional training organized by the Food Medicine Monitoring Administration.

Article 28 Quality management and inspection agents of the retailing of medicines should be on-the-jobed and should not be part-time in other enterprises.

Article 29 pharmacies should organize health inspections for persons who are directly exposed to drugs every year and establish health files. Persons found to suffer from mental illness, infectious diseases and other diseases that may be contaminated with drugs should be removed from their jobs in a timely manner.

Article 33 The manufacture of drugs and the sale of licensed enterprises shall not be sold to medicines other than the scope of the operation entrusted to it by the enterprise and shall not be subject to the distribution, sale or illicit publicity of the drug, and shall not be allowed to destroy, reproduce or rescind medicines.

Chapter IV Legal responsibility

Article 31, in violation of the provisions of this approach, stipulates that the provisions of the law, regulations, regulations and regulations have been punished in accordance with the relevant laws, regulations and regulations.

Article 32 is one of the following cases in which drug operators operate, which is warned by the Food Drugs Superintendent Management to change the time limit, with a fine of more than 50 million dollars at the end of the year:

(i) In violation of article 7 of the present approach, the absence of a computer management information system to record the acquisition, storage and sale of medicines, or the lack of timely and accurate reporting of data;

(ii) In violation of article 10 of this approach, the direct transfer of first-hand medicines from pharmaceutical-producing enterprises or other pharmaceutical-producing enterprises, or the direct allocation of non-headed medicines without qualifications from the current corporate quality manager;

(iii) In violation of article 11 of this approach, the operation of special pharmaceutical re-continental preparations does not establish customer files as prescribed or does not verify and retain information from the buyer;

(iv) In violation of article 12 of this approach, the sale of medicines is not subject to the provision of a sale certificate;

(v) In violation of article 13 of this approach, the acquisition of medicines is free of legal instruments, without the authorization, or the acceptance of the accompanying medicines is not subject to the corresponding evidence and without the required collection;

(vi) In violation of article 14 of this approach, the name of the purchaser document of the sales voucher is inconsistent with the actual payment flow or the amount of the purchase is not commensurate with the relevant financial accounts;

(vii) In violation of article 16 of this approach, the sale of special pharmaceutical re-continental preparations is not subject to the provision of identity registration, the sale of more than specified quantities, or the direct sale of drugs to minors;

(viii) In violation of article 21 of this approach, there is no regular inspection of stockpiled medicines or the non-qualified drug destruction as prescribed.

Article 33 operates in one of the following cases: a warning by the Food Medicine Superintendent Management to correct deadlines; a fine of up to 20,000 dollars in excess of 2000:

(i) In violation of article 8 of this approach, the area of the adjustment of the drug operation and the reduced operating conditions, or the adjustment of the area of the operation and the failure of the Authority to provide the food-continuation monitoring management;

(ii) In violation of article 15 of this approach, the non-implementation of prescriptions for the management and sale of pharmacies;

(iii) In violation of article 17 of this approach, the physical isolation of the sale area and therapeutic areas is not established;

(iv) In violation of article 19, paragraph 1, of the present approach, there is no subregional storage, stereotype, and a clear mark for other products other than those that are part of the medicines;

(v) In violation of article 20 of this approach, excessive coverage of adaptation or functional ownership of medicines;

(vi) In violation of article 26 of this approach, article 27 provides that staff members, such as quality management, testing, receipt, custody, conservation and business, have not obtained relevant professional technical titles, job certificates;

(vii) In violation of article 29 of this approach, persons suffering from drug security are placed in direct contact with drugs.

Article 34, in violation of article 9, paragraph 1, of this scheme, provides for the transport or warehousing of medicines with temperature requirements without taking the necessary safeguards or refrigeration measures, which are fined by the Food Pharmaceutical Superintendent of 2000 by the Illicit Drug Control Agency.

In violation of article 9, paragraph 2, of the present approach, the mailing of medicines operated by a pharmaceutical enterprise does not produce the related material that demonstrates the legitimacy of the medicines, which is being warned by the food medicine surveillance authorities, corrective action orders and fines of up to 30,000 dollars; and postal agencies or fast-moving companies are not required to detect the receipt of medicines and are treated by postal authorities in accordance with the law.

In violation of article 19, paragraph 2, of this scheme, a pharmaceutical operation violates products other than the manufacture of medicines, which are warned by the food drug control supervisory authorities to correct orders and imposes a fine of up to 50,000 dollars in the amount of the goods in conflict with the law.

Article 36, in violation of article 28 of this approach, provides that the quality management and inspection agents of the retailer of medicines are not subject to the requirement of incumbency or, in other enterprises, are warned by the food-drug surveillance management, corrective action and may be fined up to $500,000.

In violation of article 33 of the scheme, the sale of medicines by the manufacturer of medicines outside the scope of the operation entrusted to it by the manufacturer, the sale, the sale of medicines, the illegal publicity, or the unauthorized seizure, reprinting of medicines, by the food medicine surveillance management, is being warned by the food and medicine surveillance authorities, and the fine of up to $20,000.

Article 338 Food drug surveillance authorities and their staff are in favour of private fraud, negligence, abuse of their functions in the management of drug control, and administrative disposition of directly responsible supervisors and other direct responsibilities is provided by law; and criminal liability is lawfully.

Chapter V

Article 39 of this approach is implemented effective 1 February 2013.