Article 1 These Measures are formulated in accordance with the Drug Administration Law of People's Republic of China (PRC) (hereinafter referred to as the Drug Administration Law) and relevant laws and regulations in order to strengthen drug supervision and administration, standardize drug circulation order and ensure drug quality.
Article 2 These Measures shall apply to all units and individuals engaged in drug purchase and sale activities.
Article 3 Local drug supervision and administration departments at all levels shall be responsible for the implementation and supervision of these Measures within their respective jurisdictions; The State Pharmaceutical Products Supervision and Administration Bureau is responsible for organizing the investigation and handling of major and complicated cases of illegal business operations, and supervising the local pharmaceutical supervisory and administrative departments at all levels to implement these measures.
Article 4 The pharmaceutical supervisory and administrative department encourages and protects the social supervision of any unit or individual on the circulation of pharmaceuticals. In violation of these measures, any unit or individual has the right to report and accuse.
Chapter II Supervision and Administration of Sales of Pharmaceutical Production Enterprises
Article 5 Pharmaceutical producing enterprises can only sell drugs produced by their own enterprises.
Article 6 An office set up by a pharmaceutical production enterprise shall not sell drugs on the spot. The office must accept the supervision and management of the local drug supervision and administration department. The activities of the office shall be undertaken by the enterprise that set up the office.
Article 7 Pharmaceutical production enterprises shall not engage in the following sales activities:
(1) Selling the drugs produced by this enterprise to units or individuals without the License for Pharmaceutical Manufacturing Enterprises, the License for Pharmaceutical Trading Enterprises and the License for Practice of Medical Institutions, as well as individual medical practitioners in rural areas, clinics and towns;
(2) selling drugs produced by the enterprise in the illegal drug market or other bazaars;
(3) selling prescription drugs to non-prescription drug business units;
(4) selling drugs with changed production batch numbers;
(5) Drugs whose sales instructions and labels do not meet the requirements;
(6) selling drugs that violate the provisions on the administration of drug approval numbers;
(seven) other circumstances prohibited by laws and regulations.
Article 8 It is forbidden for pharmaceutical production enterprises to provide drugs to units or individuals without a Pharmaceutical Production Enterprise License, a Pharmaceutical Trading Enterprise License and a Medical Institution Practice License in the form of debt repayment and payment.
Chapter III Supervision and Administration of Pharmaceutical Trading
Article 9 Anyone who engages in pharmaceutical trading must obtain a Pharmaceutical Trading Enterprise License and a Business License in accordance with the provisions of the Drug Administration Law. Otherwise, it shall not engage in drug business.
Tenth pharmaceutical wholesale enterprises must have a true and complete record of drug purchase and sale. Drug purchase and sale records must be recorded: the date of purchase and sale; Purchase and sale target; The number of purchases and sales; The name, specification, production batch number, production unit, approval number, signature of the agent and person in charge of the drug and other contents stipulated by the State Administration of Pharmaceutical Products. Drug purchase and sale records must be kept for more than one year, but not less than three years. If there is no record of drug purchase and sale, it shall be handled in accordance with the provisions of Article 47 of these Measures.
Eleventh pharmaceutical retail enterprises must establish a true and complete record of drug purchase. The items recorded in the drug purchase records shall be implemented in accordance with the provisions of Article 10 of the Purchase and Sale Records. Drug purchase records must be kept for more than one year, but not less than two years. The retail of prescription drugs and over-the-counter drugs shall be implemented in accordance with the provisions of the Measures for the Administration of Classification of Prescription Drugs and Over-the-Counter Drugs.
Twelfth without approval, pharmaceutical wholesale enterprises shall not engage in pharmaceutical retail business; Drug retail units shall not engage in drug wholesale business.
Article 13 The following acts are not allowed in drug trading:
(1) Forging records of drug purchase and sale or purchase;
(two) in violation of the provisions of these measures, the purchase and sale of drugs to units or individuals without the license for pharmaceutical production enterprises, the license for pharmaceutical trading enterprises and the license for medical institutions, as well as individual medical practitioners and individual clinics in cities and towns;
(3) Participating in the illegal drug trading market or other bazaars or providing drugs to them;
(4) Doctors shall not sell prescription drugs to consumers;
(5) Other circumstances prohibited by laws and regulations.
Article 14 It is forbidden for pharmaceutical trading enterprises to pay off debts for goods to units without a License for Pharmaceutical Production Enterprises, a License for Pharmaceutical Trading Enterprises and a Practice License for Medical Institutions, and to provide medicines for their unlicensed operations.
Article 15 pharmaceutical trading enterprises shall not provide business counters, booths, invoices, tax payment vouchers, photos, etc. to any unit or individual. , so as to provide conditions for its drug business, lease, lend and transfer the Pharmaceutical Trading Enterprise License.
Article 16 pharmaceutical production and marketing enterprises and medical institutions must report to the local pharmaceutical supervisory and administrative department in time when they find fake and inferior drugs or drugs with suspicious quality in the purchase and sale of drugs, and may not sell them themselves or return or exchange them. Imported drugs found in import inspection shall be handled in accordance with the provisions of the Measures for the Administration of Imported Drugs.
Seventeenth pharmaceutical retail chain headquarters and chain stores, must obtain the "pharmaceutical trading enterprise license".
Eighteenth in addition to the state approved the establishment of Chinese herbal medicine professional market, it is strictly prohibited to set up various forms of drug market.
Article 19 The specialized market of Chinese herbal medicines prohibits the sale of medicines other than Chinese herbal medicines, Chinese herbal pieces and Chinese herbal pieces which are prohibited by the state from being sold in the specialized market of Chinese herbal medicines.
Twentieth urban and rural fairs can sell real estate Chinese herbal medicines, unless otherwise stipulated by the state. The urban and rural fairs prohibit the sale of drugs other than Chinese herbal medicines.
Twenty-first units or individuals without a license for pharmaceutical trading enterprises are strictly prohibited from engaging in pharmaceutical trading activities. In any of the following circumstances, it shall be handled as unlicensed operation:
(1) Having a License for Foreign Business of Pharmaceutical Trading Enterprises;
(2) The non-prescription drug business unit engages in prescription drugs or other businesses beyond the scope;
(three) urban individual practitioners and individual clinics engaged in drug purchase and sale activities in violation of regulations;
(four) township hospitals in violation of the provisions of article twenty-eighth, without the consent of the drug supervision and administration department at the county level to purchase drugs;
(five) illegal purchase of drugs;
(six) veterinary drug business units dealing in drugs for human use;
(7) Participating in drug trading with the conditions provided by drug trading enterprises without the License for Drug Trading Enterprises;
(eight) engaged in the domestic sales of imported drugs without the "Pharmaceutical Trading Enterprise License";
(nine) in violation of the provisions of the fifth and sixth paragraphs of these measures;
(ten) in violation of the provisions of the thirtieth paragraph of these measures;
(eleven) other circumstances prohibited by laws and regulations.
Twenty-second imported drugs that have obtained the Registration Certificate of Imported Drugs are sold in the domestic market, and foreign pharmaceutical production enterprises must choose legal domestic sales agents for imported drugs in China.
Article 23 To distribute imported drugs, a copy of the Registration Certificate of Imported Drugs stamped with the official seal of the distribution enterprise and the drug inspection report of the port drug inspection office must be issued in accordance with the provisions of the Measures for the Administration of Imported Drugs.
Article 24 Domestic sales agents of imported drugs must file with the State Administration of Pharmaceutical Products. If there is any change in the recorded items, the change procedures must be handled.
Twenty-fifth imported drugs sold in China, must accept the supervision and management of the local drug supervision and administration department. If the quality is found to be suspicious, the local provincial drug inspection agency may conduct inspection. When necessary, you can ask the China Institute for the Control of Pharmaceutical and Biological Products for the standards and standards of this variety for inspection, or transfer them to the nearest port drug inspection institution for inspection.
Chapter IV Supervision and Administration of Drug Purchase
Twenty-sixth pharmaceutical trading enterprises and medical institutions must purchase drugs from pharmaceutical production enterprises and trading enterprises with the License for Pharmaceutical Production and Trading Enterprises. It is strictly forbidden to purchase drugs from other channels. In addition to buying Chinese herbal medicines.
Twenty-seventh individual medical practitioners and individual clinics in cities and towns shall not open pharmacies or engage in drug purchase and sale activities.
Twenty-eighth rural self-employed doctors and clinics use drugs, should be purchased from the nearest pharmaceutical trading enterprises or their extended outlets; If there are no pharmaceutical trading enterprises or extended outlets, with the consent of the county-level pharmaceutical supervisory and administrative departments, township hospitals may be entrusted for unified procurement. It is strictly forbidden to purchase drugs from other channels.
Twenty-ninth township hospitals need drugs and purchasing drugs, and they must buy them from pharmaceutical trading enterprises with the License for Pharmaceutical Trading Enterprises. It is strictly forbidden to purchase drugs from other channels.
Thirtieth township health centers on behalf of rural individual doctors and clinics to buy drugs, except for necessary and reasonable expenses, shall not be used for business sales.
It is strictly forbidden for township hospitals to entrust or contract drug procurement to individuals.
Thirty-first pharmaceutical trading enterprises, medical institutions and rural individual practitioners shall not engage in the following procurement activities:
(1) Purchasing drugs from units and individuals without a Pharmaceutical Manufacturing Enterprise License or a Pharmaceutical Trading Enterprise License;
(2) purchasing drugs from the illegal drug market;
(3) Purchasing preparations prepared by medical institutions;
(four) to buy drugs beyond the scope of business from drug dealers;
(five) in violation of the provisions of Article 28 and Article 29 of these measures, purchasing drugs through channels;
(6) Other circumstances prohibited by laws and regulations.
Article 32 A true and complete drug purchase record must be established when purchasing drugs. The matters recorded in the drug procurement records shall be implemented in accordance with the provisions of Article 10 of these Measures.
In violation of the provisions of article eleventh and this article, there is no record of drug purchase, and it shall be handled in accordance with the provisions of article forty-seventh of these measures.
Article 33 When purchasing imported drugs, pharmaceutical trading enterprises and medical institutions must obtain a copy of the Import Drug Registration Certificate and the import drug inspection report from the import drug distribution enterprise, and affix the official seal of the distribution enterprise for future reference.
Chapter V Supervision and Administration of Drug Salespersons
Article 34 The sales personnel of pharmaceutical production and marketing enterprises shall, within the scope of authorization, bear legal responsibilities for the personnel appointed or employed by pharmaceutical production and marketing enterprises.
Article 35 pharmaceutical sales personnel shall not engage in drug purchase and sale activities in other enterprises part-time.
Article 36 A salesperson engaged in drug trading must meet the following conditions:
(1) Having a high school education or above, and receiving corresponding professional knowledge and training in pharmaceutical laws and regulations;
(2) There is no legal record of defective products.
Article 37 The pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the administration of the training of pharmaceutical laws and regulations, and the municipal pharmaceutical supervisory and administrative departments shall be responsible for the specific implementation.
Article 38 When selling drugs, drug salesmen must produce the following certificates:
(1) Copies of the License for Pharmaceutical Production and Trading Enterprises and the Business License stamped with the official seal of the enterprise;
(two) the original power of attorney of the legal representative of the enterprise stamped with the official seal of the enterprise and the seal or signature of the legal representative of the enterprise; The power of attorney shall specify the scope of authorization.
(3) the identity card of the drug salesman.
Pharmaceutical trading enterprises and medical institutions must verify the above-mentioned documents, establish verification records, and record them in the records of drug purchase and sale or procurement according to the provisions of these Measures.
Chapter VI Punishment
Article 39 Whoever, in violation of the provisions of Item 4 of Article 7 of these Measures, changes the production batch number beyond the validity period of the drug shall be punished in accordance with the provisions of the Drug Administration Law on selling inferior drugs;
In violation of the provisions of the fourth paragraph of Article 7 of these measures, if the production batch number is changed without exceeding the validity period of the drug, it shall be punished in accordance with the provisions of Article 53 of the Drug Administration Law;
In violation of the provisions of Article 7, Item 5 of these Measures, it shall be punished in accordance with the provisions of Article 53 of the Measures for the Implementation of the Drug Administration Law;
Whoever sells drugs in violation of other provisions of Article 7 of these Measures shall be given a warning or fined between 20,000 yuan and 30,000 yuan.
Fortieth whoever deals in drugs in violation of the provisions of Article 13 of these Measures shall be given a warning or fined between 2,000 yuan and 30,000 yuan.
Article 41 Whoever purchases drugs in violation of the provisions of Article 31 of these Measures shall be given a warning or fined 1000 yuan but not more than 30,000 yuan.
Article 42 Anyone who, in violation of the provisions of Article 15 of these Measures, rents, lends or transfers the Pharmaceutical Trading Enterprise License shall be given a warning or fined 1 10,000 yuan but not more than 30,000 yuan.
Article 43 In violation of the provisions of Article 16 of these Measures, pharmaceutical production and trading enterprises and medical institutions that fail to report counterfeit and inferior drugs and drugs with suspicious quality to the local pharmaceutical supervisory and administrative departments in time may be given a warning or fined between 2,000 yuan and 20,000 yuan; Those who sell, return or exchange counterfeit drugs found shall be punished in accordance with the provisions of the Drug Administration Law on the sale of counterfeit drugs; If the drug with suspicious quality is sold, returned or exchanged, which makes it impossible for the pharmaceutical supervisory and administrative department to trace it, it shall be handled in accordance with the provisions of Article 47 of these Measures.
Article 44 Whoever violates the provisions of Articles 12, 17, 18, 19, 20, 21 and 35 of these Measures shall be punished in accordance with the provisions of Article 52 of the Drug Administration Law.
Article 45 A domestic sales agent of imported drugs who engages in domestic sales of imported drugs without filing shall be given a warning or fined 1 10,000 yuan but not more than 30,000 yuan.
Article 46 Whoever, in violation of these measures, distributes or uses imported drugs without registration certificates and inspection reports, or forges or alters the registration certificates and inspection reports of imported drugs, shall be dealt with in accordance with Article 50 of the Drug Administration Law and Article 48 of the Measures for the Implementation of Drug Administration.
If the distribution of imported drugs fails to affix the official seal of the supplier as required, and fails to obtain the registration certificate and inspection report of imported drugs as required, a warning or a fine of 1 10,000 yuan may be given.
Forty-seventh in violation of other provisions of these measures, shall be given a warning or impose a fine of ten thousand yuan.
Article 48 When imposing administrative punishment, the pharmaceutical supervisory and administrative department shall, according to its functions and powers, order the parties concerned to correct or stop the illegal act.
The drug supervision and administration department at a higher level has the right to order the drug supervision and administration department at a lower level to correct its improper administrative behavior.
Forty-ninth pharmaceutical supervisory and administrative departments in the implementation of these measures, it is strictly prohibited to abuse their powers, engage in malpractices for selfish ends, dereliction of duty. If the drug supervision and administration department and its drug supervisor commit the above acts, the principal responsible person and the person directly responsible shall be dealt with severely in accordance with the relevant provisions. If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 50 If a party refuses to accept the administrative punishment given by the pharmaceutical supervisory and administrative department in accordance with these Measures, it may apply for administrative reconsideration or bring an administrative lawsuit in accordance with the provisions of relevant laws and regulations.
Chapter VII Supplementary Provisions
Article 51 The meanings of the following terms in these Measures are:
Drug bazaar: refers to the place where the state prohibits illegal drug buying and selling activities, including drug fairs held without approval. It is a place where many unlicensed operators, operators protected by legal enterprises or licensed operators in different places relatively concentrate on independent and scattered spot drug procurement, warehousing, storage, transportation and sales activities.
Domestic sales agent of imported drugs: refers to an enterprise legal person who has obtained the License for Pharmaceutical Trading Enterprises and a pharmaceutical trading enterprise engaged in domestic sales agent of imported drugs according to the agreement signed with foreign pharmaceutical production enterprises.
Off-site operation: refers to changing the original registered place of the Pharmaceutical Trading Enterprise License without authorization to engage in pharmaceutical trading activities.
Scope of business: refers to the scope of business varieties specified in the Pharmaceutical Trading Enterprise License.
The violation of the drug approval number stipulated in Item 6 of Article 7 of these Measures refers to the act that does not constitute counterfeit and inferior drugs according to law.
The purchase and sale of drugs mentioned in Article 2 of these Measures does not include the purchase of consumer drugs by individuals.
The term "urban individual doctors and clinics" as mentioned in these Measures does not include rural individual doctors and clinics.
The term "city" as mentioned in these Measures refers to prefecture-level cities in administrative divisions, excluding county-level cities.
Article 52 The contents of drug classification management stipulated in these Measures shall be implemented after the implementation of the Measures for the Classification Management of Prescription Drugs and Non-prescription Drugs.
Article 53 If the documents on drug circulation supervision and management issued before the promulgation of these Measures are inconsistent with the provisions of these Measures, the provisions of these Measures shall prevail.
Article 54 The State Administration of Pharmaceutical Products shall be responsible for the interpretation of these Measures.
Article 55 These Measures shall be implemented as of 1 August 19991day.