Flow Of Medicines And Medical Devices, Fujian Province Supervision And Administration

Original Language Title: 福建省药品和医疗器械流通监督管理办法

Read the untranslated law here: http://www.chinalaw.gov.cn/article/fgkd/xfg/dfzfgz/201108/20110800346683.shtml

Flow of medicines and medical devices, Fujian province supervision and administration

    (November 3, 2010 61st Executive meeting of Fujian province on December 27, 2010, 112th promulgated by the people's Government of Fujian province as of February 1, 2011) Chapter I General provisions

    First in order to strengthen the supervision and administration of circulation of pharmaceuticals and medical devices, and guarantee the quality of drugs, medical devices and human security, in accordance with the People's Republic of China pharmaceutical administration law, the supervision and administration of medical devices regulations and other laws and regulations, combined with the facts of the province, these measures are formulated.

    Article within the administrative area of the province of drug and medical device purchasing, sale, storage, transportation, use, supervision and management, application of this approach.

    Article above the county level, the food and drug regulatory agency responsible for the administration of drugs and medical equipment supervision and administration of circulation. Study on the economic and trade departments in the people's Governments above the county level are responsible for developing medicines and medical devices in circulation industry development plans and industrial policies to guide industrial layout, promote technological progress and structural adjustment of industry management.

    Above the county level, the food and drug supervision and Administration Department shall cooperate with the economic and trade sectors, implementation of drug and medical device industry development programs and policies.

    Government health departments above the county level are responsible for guiding drug management of work of medical institutions, organizations implementing the national system for basic drugs, participation in drug and medical device clinical trial management.

    Population and family planning, pricing, quality supervision, industry and commerce, public security and other departments concerned within the scope of their respective duties is responsible for supervision and administration related to the circulation of drugs and medical devices.

    Township people's Government shall assist in areas of drugs, medical equipment supervision and administration of circulation.

    Article fourth drug, medical device manufacturing, trading enterprises and users shall guarantee their purchase, sale, storage, transport and use of drugs and the quality and safety of medical devices.

    Fifth in the central unified policies, under the principle of unified planning, unified organization, province people's Government establish a pharmaceutical reserve system security disasters, epidemic situations such as emergency medicine, medical equipment supply.

    Pharmaceutical reserve system implemented by the provincial economic and trade departments in organizations.

    Sixth in the medicine, the circulation of medical devices regulatory activities of units or individuals have made outstanding achievements in and above the county level, the food and drug supervision and management departments should be rewarded.

    Chapter II administration of pharmaceutical distribution

    Article seventh trading enterprises and units should have the drug production and operation of enterprises procurement of medicines, but except for purchases without approval, management of traditional Chinese medicine.

    Drug production, wholesale enterprise may not have legal qualification of pharmaceutical trading enterprises and units sales of drugs.

    Article eighth trading enterprises and use the unit of purchasing drugs, shall obtain, retain sales receipts and national information; supplied to it by the unit for the first time, following sealed by the supplier of the information should be obtained from the archive:

    (A) the pharmaceutical production license or drug business license and copy of business license;

    (B) good manufacturing practices or the medicine quality control standard authentication certificate and copy of drug approval documents;

    (C) supply unit drug sales orders;

    (D) the sales copy of valid identification.

    Drug-handling enterprises and use the unit in accordance with the provisions of the preceding paragraph of this article retained the sales documents and information, more than drugs period of validity shall be kept until the year, but not less than 3 years.

    Nineth pharmaceutical trading enterprises and used purchase, should establish and implement incoming inspection system of pharmaceuticals certificates and other marks do not comply with the requirements may not be purchased.

    Drug distributors and users purchase drugs must be true and complete acceptance of procurement records, purchase acceptance record shall be confirmed by the signature of acceptance.

    Tenth Strip pharmaceuticals production, wholesale business selling medicines, should be issued indicating the purchases unit name, drug name, manufacturer, quantity, batch number, dosage form, specifications, prices and so on sales documents and seal.

    Pharmaceutical retail enterprise selling drugs issued shall be marked with a drug name, manufacturer, lot number, quantity, price and other sales documents.

    Pharmaceutical production and trade enterprise sales sales of medicines must be true and complete record.

    11th acceptance of drug purchases and sales records, you should indicate the drug's generic name, manufacturer (indicating their origin of Chinese herbal medicines), dosage form, specifications, batch number, expiry date, the approval number, purchase and sale, purchase and sale quantity, purchase price, purchase date, and so on.

    Acceptance of drug purchases and sales records shall be kept until the more than medicine valid for 1 year, but not less than 3 years.

    12th Strip pharmaceuticals production and management enterprises and users shall, according to pharmaceutical standards and specification of requirements, take the appropriate refrigeration, freezing, moisture, protected from light, ventilation, pest control, dust control, prevention measures, such as storage, transport medicine and drug monitoring and maintenance records.

    Pharmaceutical production and management enterprises and users can delegate to the guarantee drug quality and safety conditions of enterprise storage, transport medicine.

    13th drug distributors and users should regularly check the stock medicines, expired, spoiled by pollution, substandard drugs, should be inventoried and destroyed in accordance with the relevant provisions.

    14th the business diversified into non-drug, drug and non-drug-zones, should be counter storage, display, and set clear identification.

    Article 15th specifications, indicated by the label indications or indications, shall not exceed the scope approved by the State food and drug administration.

    Non-pharmaceutical brochures, labels and their promotional material, shall not involve elements of drug indications or indications.

    16th medical organizations sets a drug store, pharmacy or medicine cabinet, should have the appropriate premises, equipment, storage facilities, health and environmental conditions, the specific conditions of the provincial food and drug supervision and management departments and health departments jointly developed and made public.

    17th pharmaceutical firms to provide medicines for patients with doctor's prescriptions, not open counter, trial, free clinics, sale, advice, such as sales or disguised sales of drugs.

    Chapter III medical devices distribution

    18th medical equipment enterprises and users shall be ineligible for medical device manufacturing, business purchase medical equipment. Medical device distributing Enterprise shall not operate without registration, without certificates, expired, invalid or obsolete equipment.

    Medical device using the unit must not be used without registration, without certificates, expired, invalid or obsolete equipment.

    Article 19th medical equipment enterprises and users buy medical equipment, shall obtain, retain sales documents as well as national information; supplied to it by the unit for the first time, following sealed by the supplier of the information should be obtained from the archive:

    (A) the medical device manufacturing enterprise license or copy of the medical device distributing Enterprise license and license, production, first in the undertakings belonging to the category of medical devices class I medical devices business, simply request a photocopy;

    (B) medical device registration certificate and a copy of the registration of medical device registration form;

    (C) the supplier medical equipment sales orders;

    (D) the sales copy of valid identification.

    Medical device distributing enterprise and use the unit in accordance with the provisions of the preceding paragraph of this article retained the sales documents and information should be preserved to over 1-year validity or use of medical devices, but not less than 2 years.

    20th medical equipment enterprises and users buy medical equipment, should establish and implement incoming inspection and acceptance system, identify medical device certificates and other marks do not comply with the requirements, shall not be purchased.

    Medical equipment enterprises and units purchased medical equipment must be true and complete acceptance of procurement records, purchase acceptance record shall be confirmed by the signature of acceptance.

    21st medical device manufacturers selling medical devices should be issued indicating the purchase name registration name, product, medical device license number, specification, quantity, price, manufacturer, production batch number or product number, such as the content of sales documents, under seal.

    Medical device distributing enterprise sales second to third in the category of medical devices class I medical devices, should be issued indicating the purchases unit names, medical device registration number, name, product specifications, quantity, price, manufacturer, lot number or serial number of the products content of sales documents, under seal.

    Medical device manufacturing, enterprise sales sales of medical devices must be true and complete record. 22nd acceptance of medical device purchasing, sales records, medical devices which shall be indicated the name, specifications, batch number or product number, expiry date, manufacturer, date of production, purchase and sale, product registration card, number, purchase and sale, purchase price, purchase date, and so on.

    Sterile medical devices must indicate the date of sterilization, sterilization lot number.

    Acceptance of medical device purchasing, sales records should be kept beyond the expiration date or use the period of 1 year, but not less than 2 years purchase acceptance of single-use sterile medical devices, sales records, should be kept well beyond their expiration date 2; acceptance of implantable medical device purchasing, sales records should be stored permanently.

    Article 23rd medical device production, management of enterprises and units shall, in accordance with product standards and specification of requirements storage, transportation, medical equipment, and the establishment of medical equipment maintenance records.

    Medical device manufacturing, trading enterprises and users can delegate the ability to guarantee quality and safety of medical devices terms of enterprise storage and transport products.

    24th medical apparatus used shall meet the following conditions, diagnosis and treatment, medical devices can be used:

    (A) the sound management system, medical devices used;

    (B) meets the requirements of medical device performance sites, facilities, equipment and hygiene conditions;

    (C) compatible with the medical devices used by technicians;
(D) other conditions stipulated by laws and regulations.

    25th medical apparatus and use units of implantable medical devices, should be established and permanently holds the following records:

    (A) name, sex, age, address, mailing address, phone number, medical record number, duration of surgery, surgeon;

    (B) the name, registration number, serial number of the products, specifications, production date, batch number, period of validity;

    (C) manufacturer's name, registered address, production, production, Enterprise license;

    (D) the supplier's name and license number.

    Patients requesting use of the provisions of the preceding paragraph records, medical equipment units should be provided.

    Supervision and administration of the fourth chapter

    26th district over food and drug supervision and management departments should establish and improve the day-to-day supervision and inspection, certified checks, inspection system, strengthen supervision and inspection of pharmaceutical, medical equipment and distribution.

    Food and drug supervision and administration departments at or above the County shall establish a drug, medical device manufacturing, business enterprises and use the credit management system of quality and safety, drug, medical device manufacturing, business enterprises and the use of acts in violation of the quality and safety of credit records, illegal units to the public. 27th pharmaceutical, medical equipment enterprises and use the unit to direct contact with drugs, sterile medical personnel, health checks once a year, and health records.

    Drugs, medical equipment enterprises and users shall not be arranged with contagious diseases or any other diseases might contaminate the drug, sterile medical devices staff, engaged in direct contact with the pharmaceuticals, of sterile medical devices.

    28th pharmaceutical, medical device manufacturing enterprises should take the initiative to recall unsafe drugs and medical devices, taken against drug and medical device recall remedies, decontamination and destruction measures, and drug and medical device recall and report local food and drug supervision and Management Department of management.

    Drug and medical device manufacturers should recall not voluntarily recalled drugs, medical devices, provincial food and drug supervision and Administration Department shall order the immediate recall, if necessary, may require the production of pharmaceuticals, medical devices, Enterprise and using the unit immediately to stop the sale and use of the drug and medical devices.

    Article 29th of pharmaceuticals, medical equipment enterprises and units found its operation, use of unsafe drugs and medical devices, can cause damage to human health and safety, should immediately stop selling or using the drugs, medical devices, and inform drug and medical device manufacturers or suppliers, and to report to the local food and drug supervision and administration departments.

    Article 30th advertising of the province's production of pharmaceuticals, medical devices, should be approved by the provincial food and drug administration; released mainland-produced drug advertisements, before you publish it to the provincial food and drug supervision and Administration Department.

    Provincial food and drug supervision and management departments should be pharmaceuticals, medical equipment approval and record of posting for public inquiry, supervision, and copy to the provincial industrial and commercial administration departments for the record in a timely manner.

    31st over food and drug supervision and Administration Department shall, within their respective administrative areas of medicine, medical monitoring equipment, without approval or inconsistent with the approved scenarios, such as the illegal advertisements of medicines, medical devices, should be transferred to the Administrative Department for industry and Commerce investigated and dealt with at the same level in a timely manner. Articles 32nd to arbitrary expansion of indications (indications) and absolute exaggerate the effect of the scope, serious fraud and illegal advertisements of misleading the consumers of pharmaceuticals, medical devices, provincial food and drug supervision and Administration Department shall take administrative enforcement measures, suspended the drug, medical device sales in the area, using, and to order the release illegal ads in local media published correction.

    Of the release illegal ads after the correction is published according to the requirements of enterprises, provincial food and drug supervision and Administration Department shall, within 15 working days to make the Disarmament decision of compulsory administrative measures.

    Harming the legitimate rights and interests of consumers of illegal advertising of pharmaceuticals, medical devices, enterprises shall bear civil liability for publishing illegal ads. Article 33rd trading enterprises and units from carrying out Government prices or Government guided or market-regulated prices, use price labels in accordance with regulations.

    Prohibit profiteering and harm the interests of users of price frauds. Bidding approach to law should be centralized procurement of drugs by medical institutions, should take part in centralized purchasing of drugs and reduce drug prices.

    Other medical institutions are encouraged to participate in centralized drug procurements.

    Pricing departments should publicize the law to Government pricing or Government guidance prices the price of drugs, strengthen daily supervision and inspection, and promptly investigate and deal with illegal pricing.

    Food and drug supervision and administration departments at or above the County to find drug pricing violations, shall promptly transfer price Department investigated and dealt with at the same level.

    34th District more food and drug supervision and management departments should strengthen the drug circulation of medical devices and electronic network monitoring and system construction, promoting the circulation of medicines and medical equipment network information management.

    Pharmaceutical and medical device manufacturing and trading enterprises and using units shall establish drug and computer management system of medical equipment management, the use of information and input procurement, sales of medicines and medical devices in a timely manner, the use of information, and food and drug supervision and management oversight.

    Drug and medical device information and transactions through the Internet service shall comply with the provisions of relevant State laws and regulations.

    35th County and more food and drug supervision and management departments should establish and improve the rural drug supply and quality and safety supervision network, strengthening the standardized management of rural drug market to protect rural drug quality and safety.

    Article 36th County over food and drug supervision and management departments should be in drug and medical device distributing Enterprise prominent positions and use a public telephone. Citizens, legal persons or other organizations against drugs, medical devices in circulation illegal is entitled to complain to the food and drug supervision and administration departments at or above the county or information.

    Food and drug supervision and administration departments at or above the County after receiving the complaints, the report should be dealt with according to law in a timely manner; reported complaints, not part of the duties of the Department, it shall transfer the relevant Department and inform the whistle-blower complaints,.

    Chapter fifth penalty

    37th article violates this article seventh paragraph, pharmaceutical manufacturing, wholesale business unit of drug use do not have-legal sale of pharmaceutical products, by the food and drug supervision and administration departments at or above the County ordered corrective action and give a warning, and a million the following fines in serious cases, fined 10,000 yuan and 30,000 yuan fine.

    38th under any of the following circumstances, by the food and drug supervision and administration departments at or above the County a rectification and give a warning; it fails, and fined 1000 Yuan and 10,000 yuan fine:

    (A) in violation of the first paragraph of this article eighth, drug use does not obtain, retain sales voucher and national data;

    (B) the breach of paragraph II of this article Nineth, drug use is no real complete acceptance of purchase records;

    (C) in violation of the first paragraph of this article 12th, drug use is not in accordance with the regulations of storage, transportation, medicines;

    (D) violation of the first paragraph of this article 23rd, medical equipment production and management company provides storage, transport and use is not of medical devices.

    39th disobey article 17th, drug use unit sales or disguised sales of drugs, by the food and drug supervision and administration departments at or above the County ordered corrective action and give a warning, and a sales or disguised fined not more than twice times the amount value of domestic sales, but up to 30,000 yuan.

    40th under any of the following circumstances, by the food and drug supervision and administration departments at or above the County ordered corrective action and given a warning and a fine of 2000 Yuan and 20,000 yuan fine:

    (A) in violation of these regulations article 16th, the establishment of medical institutions of pharmacy, pharmacy or medicine cabinet, does not meet the required conditions;

    (Ii) violates the provisions article 24th of this approach, units do not meet the requirements of medical devices used medical device, including diagnosis and treatment;

    (C) in violation of these regulations article 27th, pharmaceuticals, medical devices business and use the unit to direct contact with drugs, sterile medical devices is not an annual health check, arrangements suffer from infectious diseases or other potentially contaminated medicines, diseases of sterile medical devices staff, engaged in direct contact with the pharmaceuticals, of sterile medical devices.

    41st under any of the following circumstances, be ordered by the food and drug supervision and administration departments at or above the county corrections, given a warning and a fine of 3000 Yuan and 30,000 yuan fines:

    (A) violation of the first paragraph of this article 19th, enterprises and use of medical devices does not obtain, retain sales receipts and national data;

    (B) the violation of the article 21st of this approach, the second paragraph, medical device manufacturing, enterprise does not draw up the sales voucher;

    (C) violation of the second paragraph of this article 20th, 21st paragraph, medical device manufacturing, trading enterprises and users have no real complete acceptance of purchase and sales records;

    (D) violation of the first paragraph of this article 25th, medical device unit was not established and permanently implantable medical device using records.

    42nd staff of the food and Drug Administration on drug and abuse in the supervision and administration of circulation of medical devices, malpractice, neglect their duties, shall be subject to punishment constitutes a crime, criminal responsibility shall be investigated according to law.

    Article 43rd acts in violation of these rules, laws and regulations are provided, from its provisions.

    The sixth chapter supplementary articles

    Article 44th of pharmaceuticals, medical devices used in these measures refers to established by law to use pharmaceuticals, medical, family planning technical service institutions of medical devices, blood collection and supply institutions, disease prevention and control institutions and medical beauty care and treatment institutions. 45th article of the rules take effect on February 1, 2011.