Chapter I General
Article 1 In order to strengthen the supervision and management of the circulation of medicines and medical devices, to ensure the safe and effective use of medicines and medical devices, and to safeguard human health and safety of life, according to the relevant national laws and administrative regulations, combined with the actual situation in this province, the formulation of these regulations.
Article II of the administrative region of the province of drugs and medical equipment procurement, transportation, storage, sales, use and supervision and management activities, the application of these regulations.
Article III of the people's governments at or above the county level shall establish and improve the supervision and management of the circulation of medicines and medical devices coordination mechanism and responsibility mechanism, unified organization and coordination of the administrative region of the supervision and management of the circulation of medicines and medical devices.
Provinces, cities, autonomous regions, counties (cities, districts) drug supervision and management departments (hereinafter referred to as the county drug supervision and management departments) is responsible for the administrative area of the supervision and management of the circulation of drugs and medical devices; other relevant administrative departments should be in accordance with their respective responsibilities in accordance with the law to do a good job in the circulation of medicines, medical equipment related supervision and management work.
The township people's government to assist in the supervision and management of the circulation of drugs and medical devices within the jurisdiction.
Article IV drugs, medical devices production, operation and use of units should ensure that their procurement, transportation, storage, sales, use of drugs and medical equipment quality and safety.
Article 5 of the drugs, medical equipment circulation supervision activities in the distribution of units or individuals to make significant achievements, the people's government at or above the county level or above the county drug supervision and management department shall give recognition and reward.
Chapter II circulation of drugs
Article 6 of the drug production, operation and use of units should be approved in accordance with the law of the scope of production, operation and use, from the drug production and operation of qualified enterprises to purchase drugs; however, the procurement of Chinese herbal medicine without the implementation of the approval number management except.
Drug production and wholesale enterprises shall not sell drugs to drug production, operation and use of units that do not have the legal qualifications.
Article VII of the drug production, wholesale enterprises selling drugs, shall issue sales vouchers labeled with the name of the purchasing unit, the generic name of the drug, manufacturer, dosage form, specifications, batch number, quantity, price and other content, and stamped with a seal.
Drug retailers selling prescription drugs and Class A non-prescription drugs, should be issued with a sales voucher labeled with the generic name of the drug, quantity, price, batch number and other content.
Article VIII of the drug production, operation and use of drugs purchased by the unit, shall request, retain sales vouchers and related information required by the state; for the first time to its supply of units, it should also request the following information filed with the seal of the unit:
(a) a copy of the drug production license or drug business license and business license;
(b) "Drug Manufacturing (ii) "Drug Production Quality Management Standard" or "Drug Business Quality Management Standard" certification and a copy of the drug approval documents;
(iii) the supplier of drug sales power of attorney;
(iv) a copy of the salesperson's valid identification;
(v) sales vouchers sample tickets.
Article IX of the drug production, operation and use of drug purchases should establish the purchase inspection and acceptance system, and in accordance with state regulations to establish the purchase, acceptance records. Sales of drugs should be established sales records.
Drug purchase, acceptance and sales records, should indicate the generic name of the drug, manufacturer, dosage form, specifications, batch number, expiration date, approval number, purchase and sale of units, purchase and sale of quantities, purchase and sale of prices, purchase and sale of the date and so on. Drug acceptance records should also indicate the acceptance of the quality of the situation and the treatment of opinions, and acceptance of the signature of the personnel to confirm.
Drug purchases, acceptance and sales records should be kept until more than one year of the validity of drugs, and not less than three years.
Article 10 of the drug production, operation and use of units and enterprises engaged in drug logistics business transportation, storage of drugs should be carried out in accordance with the requirements of the product specification, with the appropriate shade, refrigeration, light, ventilation, anti-freezing, moisture-proof, insect-proof, dust-proof, rodent-proof facilities and other conditions, and temperature, humidity control equipment, and the establishment of drug monitoring, maintenance records.
Article 11 of the drug business enterprises operating non-pharmaceuticals, drugs and non-pharmaceuticals should be divided into areas, sub-counter display, and set up obvious signs.
Article 12 of the drug packaging, labeling, instructions and related promotional materials indicated indications or functions, shall not exceed the scope approved by the State Drug Administration.
Non-drugs shall not be labeled with the common name of the drug, its instructions, labels and packaging identification shall not involve the content of the drug indications or functions.
Article XIII of the medical institutions shall be equipped with and use of essential drugs in accordance with state regulations.
Medical institutions to provide patients with medicines should be based on the unit's physician's prescription. Patients requesting paper prescriptions, medical institutions must provide.
Medical institutions shall not sell or disguise the sale of drugs by mail, open counter self-selection, trial and other ways.
Article 14 of the drug use unit set up a pharmacy or medicine cabinet, should have the appropriate personnel, premises, equipment, storage facilities, sanitation and other conditions to ensure the safety of patients with medication, and to comply with the relevant competent authorities of the provincial people's government to formulate the quality of the use of medicines management standards.
Article 15 of the drug retail enterprises and drug use units to deploy the drug tools, packaging materials, containers and the working environment, should be in line with the health and quality and safety requirements of drugs.
Drug retailers and pharmaceutical units of the smallest package of drugs zero, should make a good record of zero, and will be packaged, labeled and instructions to save until the sale or use of drugs finished. Drugs after the split containers or packaging surface should indicate the generic name of the drug, dosage form, specifications, batch number, usage, dosage, duration of use and other content.
Article 16 of the pharmaceutical production and operation of enterprises to donate drugs, should be provided to the recipient of the drug production or operation license, a copy of the drug approval documents, drug manufacturers or statutory bodies issued by the donation of a copy of the drug test report and the state regulations of the relevant information. Other donors who do not have the qualifications for drug production or operation shall provide the donee with legal proof of drug procurement. The donee shall check and accept in accordance with the provisions of Article 9, and establish acceptance records.
The actual expiration date of the donated drugs is generally not less than six months.
Article 17 of the drug production, operation and use of units should be regularly checked on the stock of drugs, drugs affecting the quality of hidden dangers, should be eliminated in a timely manner; expired, contaminated, deteriorated and other unqualified medicines, should be registered, and in accordance with the relevant provisions to be destroyed.
Chapter III circulation of medical devices
Article 18 of the medical equipment production, sales of medical equipment business enterprises should be issued to indicate the name of the purchasing unit, the name of the medical device, the product registration number, specifications, quantities, prices, manufacturers, production batch number or product number of the content of the sales voucher, and stamped with the seal.
Article 19 of the medical device business and the use of medical devices purchased by the unit, should be requested, retain sales vouchers and related information required by the state; for the first time to its supply of units, but also should be requested to file the following information stamped with the unit seal:
(a) medical device manufacturer's license or medical device business license and a copy of the business license;
(B) medical device registration certificate and a copy of the medical device registration form;
(C) the supplier of medical equipment sales power of attorney;
(D) a copy of the salesperson's valid identification.
The transfer of medical devices between medical institutions should provide the transferee with the manufacturer or statutory body issued by the transfer of the test certificate and the state regulations of the relevant information.
Article 20 of the medical device business and the use of procurement of medical devices should be established to purchase inspection and acceptance system, check the supplier's production or business qualifications, product approval documents, medical device certification and packaging markings, marking, and the establishment of procurement, acceptance records. Sales of medical devices should be established sales records.
Medical device purchase, acceptance, sales records, must indicate the name of the medical device, product registration number, specification number, production batch number or product number, expiration date, manufacturer, purchase and sale of units, purchase and sale of quantities, purchase and sale of prices, purchase and sale of date. Sterile medical devices must indicate the sterilization lot number. Medical device acceptance records should also indicate the acceptance of the quality of the situation and processing advice, and acceptance of the signature of the personnel to confirm.
Medical device purchasing, acceptance, sales records should be kept until more than the expiration date or the use of one year, and not less than two years. Implantable medical devices procurement, acceptance, sales records should be kept permanently.
Article 21 of the medical device business and the use of units should be in accordance with product standards and instructions for the transportation and storage of medical devices, and the establishment of medical device maintenance records.
Article 22 The use of medical devices shall have the following conditions:
(a) a sound management system for the use of medical devices;
(b) the performance of medical devices to meet the requirements of the premises, facilities, equipment and sanitation;
(c) with the use of medical devices compatible with the technicians;
(d) laws and regulations provide other conditions.
Article 23 of the use of medical devices using sterile medical devices, should be in contact with the inner packaging of medical devices and the expiration date of the inspection in advance; inner packaging is damaged, poorly labeled, more than the expiration date, shall not be used.
Article 24 of the medical device use units using implantable medical devices, shall establish, permanently save and provide patients with the following records of use:
(a) the patient's name, gender, age, address, mailing address, contact phone number, medical record number, name of the operation, surgery, time of surgery, the surgeon;
(b) the name of the product, the registration certificate number, product code, Specification model, production date, production batch number, expiration date;
(C) the name of the manufacturer, registered address, production address, manufacturer's license number;
(D) the name of the supply unit and its license number.
Article 25 The use of medical devices should be established to establish a regular testing system for medical devices, and establish testing records.
Included in the national mandatory calibration catalog of medical measuring instruments, in accordance with relevant state regulations.
Article 26 of the medical device production and operation of enterprises to donate medical equipment, should be provided to the recipient of the medical device registration certificate, medical device production or operation of a copy of the enterprise license, the manufacturer or the statutory body issued by the donation of the test certificate and the state regulations of the relevant information. Other donors who do not have the qualification of medical device production and operation shall provide the donee with legal proof of procurement of medical devices. The donee shall establish acceptance records, and the medical device will be a copy of the registration certificate reported to the local drug supervision and management department for the record.
Chapter IV Supervision and Administration
Article 27 of the drug, medical device circulation shall not have the following acts:
(a) without the permission of the drug supervision and management department or beyond the scope of the license to sell drugs, medical devices;
(b) rent, lend, buy, sell, or transfer of drugs, medical equipment licenses and other qualification documents;
(C) Facilitating the illegal operation and use of medicines and medical devices by repaying debts, bartering goods, etc.
(D) Promoting medicines by means of medical advertisements, charity clinics, charity sales, organizing training courses or healthcare lectures, etc.
(E) Selling and using non-medicines such as food, healthcare products, cosmetics, disinfectants, etc. as medicines;
(F) Providing prescription medicines directly with prescriptions without Provide prescription drugs directly on prescription or prescribe non-drugs in the prescription;
(vii) Sell or use drugs for termination of pregnancy in violation of the relevant provisions of the state and the province;
(viii) Purchase Chinese medicinal herbs from units or individuals who have not obtained the qualification for production and operation of traditional Chinese medicinal herbs;
(ix) Operate or use drugs that are unregistered, have no qualification certificates, or have failed to pass the test, Expired, expired, the state expressly eliminated medical devices;
(J) laws and regulations prohibit other acts.
Article 28 The drug supervision and management departments above the county shall strengthen the supervision and inspection of the circulation of drugs and medical devices, and establish a sampling and testing system.
Above the county drug supervision and management departments shall establish drug and medical device production, operation and use of quality and safety credit rating classification supervision and management system, the production, operation and use of drugs and medical devices in violation of the quality and safety of the credit behavior to be recorded, and serious violations of law to be announced.
Article 29 of the drugs, medical devices business enterprises to terminate the operation or closure, by the original licensing authority according to law cancellation of its drugs and medical devices business license; drugs, medical devices business enterprises no longer meet the statutory business conditions, requirements, continue to engage in business activities, by the original licensing department according to law revocation of the license license; and in the local major media announcements are canceled, revocation of licenses and permits Operator list.
Article 30 of the county above the drug supervision and management department shall strengthen the monitoring of adverse drug reactions, adverse events of medical devices supervision and management; health administrative departments shall strengthen the health care institutions in the adverse drug reactions, adverse events of medical devices report supervision and management.
Drugs, medical devices and the use of units should be equipped with full-time or part-time personnel to monitor adverse drug reactions, adverse events of medical devices, and in accordance with the relevant provisions of the state to the drug supervision and management departments to submit monitoring reports.
Article 31 above the county drug supervision and management departments shall strengthen the drug and medical device circulation electronic network monitoring and its system construction, and promote the drug and medical device circulation network information management.
Drugs and medical devices production, operation and use of units should be established drugs and medical devices procurement, sales information computer management system, timely entry of drugs and medical devices procurement, sales information, and accept the supervision of drug supervision and management departments.
The sale of drugs and medical devices through the Internet, should comply with relevant state laws and regulations.
Article 32 of the county above the drug supervision and management department shall supervise the drugs, medical devices business and use of units in direct contact with the drugs, sterile medical devices, annual health checks, and establish health records.
Drugs, medical devices business enterprises shall not arrange to suffer from infectious diseases and other possible contamination of drugs, sterile medical devices, personnel engaged in direct contact with drugs, sterile medical devices.
Article 33 of the county above the drug supervision and management department and the administration for industry and commerce shall strengthen the monitoring of drug and medical device advertising.
The drug supervision and management departments of illegal drugs and medical equipment advertisements found, should be promptly transferred to the administration for industry and commerce to deal with.
The administration for industry and commerce shall strengthen the supervision and management of pharmaceutical and medical device advertisements, investigate and deal with illegal pharmaceutical and medical device advertisements and non-pharmaceutical advertisements involving pharmaceutical publicity in a timely manner, and deal with the responsible advertisers, advertisers, and advertisers according to law, and make public announcements of the dealings to the public.
Article 34 of the drug and medical device advertisements, the province's production of drugs and medical devices, shall be approved by the provincial drug supervision and management department; are produced outside the province of drugs and medical devices, shall be issued before the provincial drug supervision and management department for the record.
The provincial drug supervision and management department shall approve the drug, medical device advertising and filing information on the Internet for public inquiry and supervision.
Article 35 without the approval or filing of unauthorized release of drugs, medical devices advertisements, the provincial drug supervision and management department shall order the advertiser to suspend the sale of its advertised products, and make a decision in accordance with the law.
The release of drugs and medical devices advertisements that expand the scope of indications or functional treatments, exaggerate the efficacy, deceive and seriously mislead the user, the drug supervision and management department of the place where the discovery is made to the provincial drug supervision and management department shall order the advertiser to suspend the sale of the advertised products, make public corrections to eliminate the effects within the corresponding scope, and make a decision on the handling of the matter according to the law; if the advertisement has caused any economic loss to another person, the advertiser Shall be compensated according to law.
Article 36: Non-pharmaceutical advertisements shall not involve the promotion of medicines.
If a non-pharmaceutical product is sold as a pharmaceutical product, it shall be seized and impounded by the drug supervision and management department of the place where it is found, and shall be submitted to the provincial drug supervision and management department for ordering to stop the sale of the product, and shall make a decision on the handling of the product according to law.
Article 37 of the drug, medical device production, operation and use of units found in their production, operation, use of drugs and medical devices have hidden safety hazards, may cause damage to human health and life safety, shall immediately stop selling, use, take the initiative to recall the relevant products, and to the location of the administrative department of health, drug supervision and management department report. Not in accordance with the provisions of this article to recall or stop the sale, use, the county above the drug supervision and management department shall order its recall or stop operating, use.
Drugs, medical devices production, operation and use of drugs and medical devices should be recalled to take remedial, harmless treatment, destruction and other measures, and the recall of drugs and medical devices and the handling of the situation reported to the local drug supervision and management departments.
Article 38 of the drugs, medical devices should be used to establish and improve the medical waste management responsibility system, the development of rules and regulations related to the safe disposal of medical waste, timely collection, transportation, storage and disposal of medical waste.
The administrative departments of health and environmental protection shall strengthen the supervision and inspection of the safe disposal of medical waste, timely investigation and handling of violations.
Article 39 of the drugs, medical devices should be truthfully announced the use of drugs, medical equipment prices, and truthfully provide patients with a list of drugs, medical equipment prices, the list of drug names should be used in the generic name of drugs.
Patients have objections to the price of drugs, medical devices used, drugs, medical devices, the use of units should make a timely response.
The price authorities shall regularly publish to the community to determine the approval of the use of drugs and medical equipment prices, strengthen the daily supervision and inspection, timely investigation and handling of price violations.
Article 40 of the people's governments at or above the county level and drug supervision and management departments shall gradually establish rural drug supply and drug quality and safety supervision network, strengthen the standardized management of the rural drug market, to protect the quality of rural drugs and the use of safety.
Article 41 above the county drug supervision and management department shall, in conjunction with the industry and commerce administration, price and other administrative departments in the drugs, medical equipment business and the use of units prominently publicized reporting telephone.
Citizens, legal persons and other organizations on the circulation of drugs, medical devices in violation of the law, the right to the county above the drug supervision and management, industry and commerce administration, price and other administrative departments to complain, report. Received the report of the department shall record the report in a timely manner, reporting matters belonging to the department's responsibilities, according to law, verification, processing, reply; reporting matters do not belong to the department's responsibilities, it should be transferred to the relevant departments in a timely manner to deal with, and inform the informant.
Chapter V Legal Liability
Article 42 violates the provisions of Article 8, Article 9, Article 16 of the Ordinance, one of the provisions of the circulation of medicines is not established or not in accordance with the provisions of the relevant records or request, retain the relevant information, by the drug supervision and management department to give a warning, ordered to make corrections within a specified period of time; failure to make corrections, the penalty shall be a fine of more than five hundred yuan five thousand yuan or less.
Violation of the provisions of Article 19, Article 20, Article 21, Article 24, Article 26 of the Ordinance, did not establish the circulation of medical equipment related records or not in accordance with the provisions of the relevant information requested, retained by the drug supervision and management department to the public announcement; responsible for the competent personnel and other personnel directly responsible for the relevant departments shall be punished according to law.
Article 43 violation of Article 10 of the Regulations, Article 32, paragraph 2, one of the provisions of the product standards and instructions are not in accordance with the requirements of the transport, storage of drugs, arrangements for infectious diseases and other possible contamination of drugs engaged in direct contact with the work of the drug, by the drug supervision and management department to give a warning, and shall be ordered to make corrections within a certain period of time; failure to make corrections, shall be sentenced to a fine of more than 2,000 yuan 20,000 yuan; The circumstances are serious, ordered to suspend business rectification, until the revocation of the drug license.
Violation of the provisions of Article 32, paragraph 2 of the Regulations, the arrangement of infectious diseases and other possible contamination of sterile medical devices engaged in direct contact with sterile medical devices, by the drug supervision and management department ordered to make corrections within a certain period of time, and notify the criticized, given a warning; on the responsible supervisory personnel and other personnel directly responsible for, by the relevant departments shall be punished according to law.
Article 44 violation of the provisions of Article 12, paragraph 2 of the Regulations, by the drug supervision and management department shall give a warning, ordered to make corrections within a specified period, confiscate the illegal sale of drugs or non-drugs and the illegal income, the illegal value of less than 10,000 yuan, and impose a fine of more than 2,000 yuan 20,000 yuan or less; the amount of the illegal value of more than 10,000 yuan, impose the amount of the illegal value of more than twice the fine of more than five times the amount of the illegal value of less than five times the amount of the fine.
Article 45 violation of the provisions of Article 27 (b), by the drug supervision and management department shall confiscate the illegal income, and impose a fine of more than double or triple the amount of illegal income; no illegal income, impose a fine of more than 20,000 yuan 100,000 yuan; the circumstances are serious, the revocation of the drug business license, medical device business license.
Article 46 of the drug supervision and management departments and other relevant departments of the staff in the supervision and management of the circulation of drugs and medical devices abuse of power, favoritism, negligence, shall be punished according to law; constitutes a crime, shall be investigated for criminal responsibility.
Chapter VI Supplementary Provisions
Article 47 of the Regulations of the meaning of the following terms:
Drugs, refers to the prevention, treatment, diagnosis of human disease, purposeful regulation of human physiological functions and the provision of indications or functional mainstays, usage and dosage of the substance, including traditional Chinese medicines, Chinese herbal medicine, Chinese medicine, Chinese medicine, chemical raw materials and their preparations, antibiotics, biochemical drugs, radioactive drugs, serums, vaccines, and other medicines, including Chinese medicines, Chinese medicine, Chinese medicine, Chinese medicine, Chinese medicine and their preparations.
Medical devices are instruments, equipment, appliances, materials or other items, including the required software, that are used individually or in combination on the human body.
Drugs, medical devices use units, refers to medical institutions, family planning technical service institutions, blood collection and supply institutions, disease prevention and control institutions, medical beauty care institutions and drug rehabilitation institutions and other units of medicine and equipment.
Article 48 of these Regulations shall come into force on November 1, 2009 .
Article 48 of the Regulations shall come into force on November 1, 2009.