Drugs are different from ordinary commodities. They are related to the survival and health of every citizen, which determines that the drug market is obviously different from the general commodity market. In addition to complying with the general laws of the market economy, the pharmaceutical market also has its own particularities. For example, special emphasis on transaction safety and order requires the participation of the country's powerful "hand" to establish a coordinated development of the pharmaceutical market order. Therefore, in the process of establishing a harmonious and healthy modern pharmaceutical market, the pharmaceutical industry cannot do without the improvement of the legal system and the establishment of a strict market access system. Article 12 of my country's "Administrative Licensing Law" stipulates that important equipment, facilities, products, and items that are directly related to public safety, personal health, and the safety of life and property must comply with technical standards and technical specifications. ,
Administrative licenses can be set for matters that are reviewed and approved through inspection, testing, quarantine, etc. At the same time, our country's laws
clearly require that enterprises or individuals engaged in pharmaceutical production or operation must have certain subject qualifications.
For example, Article 7 of my country's "Drug Administration Law" and Article 14 stipulates that pharmaceutical manufacturing and operating enterprises must be reviewed and approved by the drug regulatory department and obtain relevant licenses before they are qualified for business. In addition, with the gradual development and improvement of the pharmaceutical market, it is necessary for pharmaceutical companies to have an agency sales system. This is a natural result of the development of market economy
. However, agency sales behavior should be subject to certain restrictions. The "Measures for the Supervision and Administration of Drug Circulation (
Interim)" stipulates the supervision and management of drug sales personnel. Pharmaceutical sales personnel must meet the prescribed employment conditions, must have a certain level of education, and receive corresponding professional knowledge and training on pharmaceutical regulations. In this way, regardless of theoretical requirements or legal regulations, companies or individuals engaged in pharmaceutical business must meet certain conditions. Only those who have obtained market entity qualifications can enter the drug market for drug transactions.
After enterprises and individuals involved in drug production and operation have the corresponding qualifications and conditions, they must also comply with legal
business procedures and requirements. The "Drug Administration Law" and its "Implementing Regulations", especially the "Drug Circulation Supervision
Management Measures" strictly regulate drug business activities, clearly stipulate the drug procurement channels, and limit them to the aforementioned
Among qualified market entities. Moreover, legal norms emphasize business procedures and rules from both positive and negative sides. For example, Article 30 of the "Measures for the Supervision and Administration of Drug Circulation" stipulates that township health centers are strictly prohibited from entrusting or contracting the purchase of drugs to individuals; Article 35 prohibits the sale of drugs Personnel work part-time for other companies to carry out drug purchase and sales activities. Article 38
also clearly stipulates that when pharmaceutical sales personnel sell drugs, they must issue a certificate stamped with the official seal of the enterprise and the seal or signature of the legal representative of the enterprise
The original power of attorney and other relevant documents. These regulations on business procedures are conducive to the overall management and orderly development of the drug market, and prevent chaotic drug transactions and the circulation of counterfeit and substandard drugs in the market.
In this case, Wu acted as the sales agent of Kangxin Company, which only meant that he was qualified to sell drugs of that company
as an agent. According to legal provisions, they should engage in pharmaceutical business activities within the scope of the company's entrustment and authorization,
and the consequences of their actions shall be borne by the entrusted or hired enterprise to bear legal responsibility. Just like the legal restrictions on the business scope of pharmaceutical business enterprises, legal regulations also clearly stipulate that pharmaceutical sales personnel can no longer act as agents for other pharmaceutical manufacturers at the same time to purchase and sell pharmaceuticals. Activity.
Therefore, from February to September 2003, Wu purchased and sold drugs from Zhonghong Company several times and engaged in profit-making activities while working as an agent for selling Kangxin Company's drugs
p>The business qualifications of the business do not have the pharmaceutical business qualifications of Zhonghong Company. Wu's business behavior of "stepping on two boats" is a clear violation of current legal regulations.
Through this case, we can see that my country's pharmaceutical industry and pharmaceutical market are gradually improving, and the legal system in the pharmaceutical field is also constantly improving. At the same time, we should also see the limitations of the law, and the law has its own lag
. With the continuous development of the market economy, some people believe that the regulation that drug sales agents can only sell drugs from one company may limit the vitality and vitality of the market and should be revised. It is reported that relevant departments are revising the "Measures for the Supervision and Administration of Drug Circulation". As for whether drug sales agents can sell drugs from multiple companies at the same time, I believe the revised "Measures for the Supervision and Administration of Drug Circulation" will have clear regulations.
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"Measures for the Supervision and Administration of Drug Circulation"
Chapter 1 General Provisions
Article 1 In order to strengthen drug supervision and management, standardize the order of drug circulation, and ensure drug quality, in accordance with the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Drug Administration Law") and relevant laws and regulations stipulate and formulate these measures.
Article 2 These Measures apply to all units and individuals engaged in the purchase and sale of pharmaceuticals.
Article 3 Local drug regulatory authorities at all levels are responsible for the implementation and supervision of these Measures within their jurisdiction; the National Medical Products Administration is responsible for organizing the investigation and handling of major and complex illegal business cases, and is responsible for local drug supervision and administration at all levels The drug regulatory authorities shall supervise the implementation of these Measures.
Article 4 The drug regulatory department encourages and protects any unit or individual’s social supervision of drug circulation. Any unit or individual has the right to report and accuse any violation of these Measures.
Chapter 2 Supervision and Management of Sales by Pharmaceutical Manufacturing Enterprises
Article 5 Pharmaceutical manufacturing enterprises can only sell drugs produced by their own enterprises.
Article 6 The offices established by pharmaceutical manufacturers shall not conduct spot sales of pharmaceuticals. The office must accept the supervision and management of the local drug regulatory department. The enterprise that established the office shall bear legal responsibility for the activities carried out by the office.
Article 7 Pharmaceutical manufacturers shall not engage in the following sales activities:
(1) Selling drugs produced by the enterprise to companies that do not have a "Pharmaceutical Manufacturing Enterprise License" or "Pharmaceutical Trading Enterprise" Units or individuals with "License" and "Medical Institution Practice License" as well as individual medical practitioners, clinics in rural areas and individual medical practitioners and individual clinics in towns;
(2) In the illegal drug market or Other markets sell drugs produced by the company;
(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 comply with regulations;
(6) Selling drugs that violate drug approval number management regulations;
(7) Laws and regulations Other prohibited situations.
Eighth, pharmaceutical manufacturers are prohibited from repaying debts or payments to units or individuals that do not have a "Pharmaceutical Manufacturing Enterprise License", "Pharmaceutical Business Enterprise License" or a "Medical Institution Practice License" Providing medicines for its unlicensed operations.
Chapter 3 Supervision and Management of Pharmaceutical Business
Article 9 To engage in pharmaceutical business, one must obtain a "Pharmaceutical Business Enterprise License" and a business license in accordance with the provisions of the "Drug Administration Law" . Otherwise, they are not allowed to engage in pharmaceutical business.
Article 10: Drug wholesale operations must maintain true and complete drug purchase and sales records.
Drug purchase and sale records must record: date of purchase and sale; object of purchase and sale; quantity of purchase and sale; drug name, specifications, production batch number, production unit, approval number, signature of the person in charge, person in charge, and regulations of the State Food and Drug Administration of other content. Drug purchase and sale records must be kept for one year beyond the drug's validity period, 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.
Article 11 Article 11 Drug retail enterprises must maintain true and complete drug purchase records. The recorded items in the drug purchase record shall be carried out in accordance with the purchase regulations in Article 10 of the purchase and sale records. Drug purchase records must be kept for one year beyond the drug's validity period, but not less than two years. The retail sale of prescription drugs and over-the-counter drugs shall be carried out in accordance with the "Measures for the Classification of Prescription and Over-the-Counter Drugs".
Article 12 Without approval, pharmaceutical wholesale enterprises shall not engage in pharmaceutical retail business; pharmaceutical retail units shall not engage in pharmaceutical wholesale business.
Article 13: Drug business shall not engage in the following activities:
(1) Forging drug purchase, sale or purchase records;
(2) Contrary to regulations without " Units or individuals holding a "Pharmaceutical Manufacturing Enterprise License", "Pharmaceutical Business Enterprise License", "Medical Institution Practice License", as well as individual medical practitioners and individual clinics in cities and towns engage in drug purchase and sales activities that violate the provisions of these Measures;
(3) Participating in or providing drugs to illegal drug markets or other fair markets;
(4) Selling prescription drugs to consumers without a doctor’s prescription;
( 5) Other situations prohibited by laws and regulations.
Article 14 prohibits pharmaceutical operating companies from repaying debts or payments to units that do not have a "Pharmaceutical Manufacturing Enterprise License", "Pharmaceutical Trading Enterprise License" or a "Medical Institution Practice License" Providing medicines for its unlicensed operations.
Article 15 Pharmaceutical operating enterprises shall not provide operating counters, stalls, invoices, tax payments, certificates, licenses, etc. to any unit or individual, provide conditions for operating pharmaceuticals, rent, lend, or transfer "Pharmaceutical Operations" Enterprise License".
Article 16 If drug production and operating enterprises and medical institutions discover counterfeit or substandard drugs or drugs of questionable quality during drug purchase and sales activities, they must report them to the local drug regulatory department in a timely manner and are not allowed to sell or return them on their own. , exchange processing. If the above-mentioned drugs are found during import inspection of imported drugs, they shall be handled in accordance with the provisions of the "Administrative Measures for Imported Drugs".
Article 17 A drug retail chain store and its chain stores must obtain a "Pharmaceutical Business Enterprise License" respectively.
Article 18 Except for the professional markets for Chinese medicinal materials approved by the state, it is strictly prohibited to open various forms of pharmaceutical markets.
Article 19 It is prohibited to sell medicines other than traditional Chinese medicinal materials in professional markets for traditional Chinese medicinal materials, and it is prohibited to sell traditional Chinese medicine pieces and Chinese medicinal materials that are prohibited from being sold in professional markets for traditional Chinese medicinal materials by the state.
Article 20 Urban and rural fairs may sell real estate Chinese medicinal materials, unless otherwise stipulated by the state. The sale of medicines other than traditional Chinese medicinal materials is prohibited in urban and rural fairs.
Article 21 Units or individuals without a "Pharmaceutical Business Enterprise License" are strictly prohibited from engaging in pharmaceutical business activities.
Anyone who has any of the following circumstances will be treated as operating without a license:
(1) Those who have a "Pharmaceutical Business Enterprise License" are engaged in off-site operations;
(2) Over-the-counter drug business units operate Prescription drugs or other operations beyond the scope of business;
(3) Urban individual medical practitioners and individual clinics violate regulations and engage in drug purchase and sales activities;
(4) Township health centers violate these measures Article 28 stipulates that purchasing drugs without the consent of the county drug supervision and management department;
(5) illegally purchasing drugs;
(6) veterinary drug business units operating Drugs for human use;
(7) Those who do not have a "Pharmaceutical Business Enterprise License" and participate in the drug business by borrowing the conditions provided by the drug business enterprise;
(8) Those who do not have a "Pharmaceutical Business Enterprise License" Business Enterprise License" engaged in domestic sales of imported drugs;
(9) Violation of the provisions of Article 5 and Article 6, Paragraph 1 of these Measures;
(10) Violation of these Measures As stipulated in Paragraph 1 of Article 30 of the Measures;
(11) Other situations prohibited by laws and regulations.
Article 22 If imported drugs that have obtained the "Imported Drug Registration Certificate" are sold in the domestic market, foreign pharmaceutical manufacturers must select China's legal domestic sales agents for imported drugs.
Article 23 Those who distribute imported drugs must issue an imported drug registration certificate stamped with the official seal of the distribution enterprise and a copy of the drug inspection report of the port drug inspection institute in accordance with the provisions of the "Imported Drug Administration Measures".
Article 24 Domestic sales agents of imported drugs must register with the State Food and Drug Administration. If there are any changes to the filing matters, the change procedures must be completed.
Article 25 Imported drugs sold domestically must be subject to the supervision and management of the local drug regulatory department. If the quality is found to be suspicious, the local provincial drug inspection agency can conduct inspection. When necessary, you can request the standard products and standards of the variety from the China Institute for the Control of Pharmaceutical and Biological Products for inspection or transfer them to the nearest port drug inspection agency for inspection.
Chapter 4 Supervision and Management of Drug Procurement
Article 26 Drug trading enterprises and medical institutions must purchase from pharmaceutical manufacturing enterprises and trading enterprises that have drug production and trading enterprise licenses. Purchase medicines. It is strictly prohibited to purchase medicines from other channels. Except for purchasing Chinese medicinal materials.
Article 27 Individual medical practitioners and individual clinics in cities and towns are not allowed to set up pharmacies and are not allowed to engage in drug purchase and sales activities.
Article 28: Drugs used by individual medical practitioners and clinics in rural areas should be purchased from the nearest drug operating enterprise or its extended operating network; if there is no drug operating enterprise or extended network, the drug can be purchased through the county drug supervision and administration department. After the management department agrees, the township health center is entrusted with unified procurement. It is strictly prohibited to purchase medicines from other channels.
Article 29 The drugs required by township health centers and the drugs procured on their behalf must be purchased from drug operating enterprises with a "Pharmaceutical Distributing Enterprise License", and it is strictly prohibited to purchase drugs from other channels.
Article 30 Township health centers purchase medicines on behalf of rural individual medical practitioners and clinics, and are not allowed to conduct commercial sales except for necessary and reasonable expenses. Township health centers are strictly prohibited from entrusting or contracting the purchase of drugs to individuals.
Article 31 Pharmaceutical operating enterprises, medical institutions and rural individual medical practitioners shall not engage in the following procurement activities:
(1) Purchasing goods without a "Pharmaceutical Production Enterprise License", " Purchasing drugs by units and individuals holding a Drug Business Enterprise License;
(2) Purchasing drugs from the illegal drug market;
(3) Purchasing preparations prepared by medical institutions;
(4) Purchasing drugs beyond the scope of operation from drug dealers;
(5) Purchasing drugs through channels that violate Articles 28 and 29 of these Measures;
p>
(6) Other situations prohibited by laws and regulations.
Article 32 When purchasing drugs, true and complete drug purchase records must be kept.
The recorded items in the drug purchase record shall be carried out in accordance with the purchase provisions in the purchase and sale records in Article 10 of these Measures.
Anyone who violates Article 11 and this Article and has no drug purchase record shall be dealt with in accordance with Article 47 of these Measures.
Article 33 When purchasing imported drugs, drug operating enterprises and medical institutions must obtain the imported drug registration certificate and a copy of the imported drug inspection report from the port drug inspection office from the imported drug distribution enterprise, and stamp the The official seal of the company shall be retained for future reference.
Chapter 5 Supervision and Management of Pharmaceutical Sales Personnel
Article 34 The behavior of sales personnel of pharmaceutical manufacturing and operating enterprises within the scope of entrustment and authorization shall be determined by the appointed or hired pharmaceutical personnel. Production and operating enterprises bear legal liability.
Article 35 Pharmaceutical sales personnel are not allowed to work part-time for other enterprises to engage in pharmaceutical purchase and sales activities.
Article 36 Sales personnel engaged in pharmaceutical business must meet the following conditions:
(1) Have an education level of high school or above, and receive corresponding professional knowledge and pharmaceutical regulations training ;
(2) No record of bad conduct in law.
Article 37 The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the management of pharmaceutical regulations training, and the municipal drug regulatory departments are responsible for specific implementation.
Article 38 When pharmaceutical sales personnel sell drugs, they must produce the following documents:
(1) Pharmaceutical production and operation enterprise license and business license stamped with the official seal of the enterprise Copy of the letter;
(2) 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 should clearly specify the scope of authorization.
(3) ID card of the drug salesperson.
Drug operating enterprises and medical institutions must inspect the above documents, establish inspection records, and record them in drug purchase, sale or purchase records in accordance with the provisions of these Measures.
Chapter 6 Penalties
Article 39 Anyone who violates the provisions of Article 7, Paragraph 4 of these Measures and changes the production batch number beyond the validity period of the drug shall be deemed to be selling inferior drugs and shall be punished in accordance with the " Penalties stipulated in the Drug Administration Law;
Anyone who violates Article 7, Paragraph 4 of these Measures and changes the production batch number within the validity period of the drug shall be punished in accordance with Article 53 of the Drug Administration Law;
Violation of Article 7, Paragraph 5 of these Measures shall be punished in accordance with Article 53 of the "Measures for the Implementation of the Drug Administration Law";
Violation of other provisions of Article 7 of these Measures for sales Those who use drugs will be given a warning or a fine of RMB 20,000 to RMB 30,000.
Article 40 Anyone who deals in drugs in violation of Article 13 of these Measures shall be given a warning or a fine of RMB 2,000 to RMB 30,000.
Article 41 Anyone who purchases drugs in violation of Article 31 of these Measures shall be given a warning or a fine of RMB 1,000 to RMB 30,000.
Article 42 Anyone who violates the provisions of Article 15 of these Measures by renting, lending or transferring the "Pharmaceutical Business Enterprise License" shall be given a warning or a fine of RMB 10,000 to RMB 30,000.
Article 43: Drug production and operating enterprises and medical institutions that violate the provisions of Article 16 of these Measures and fail to promptly report to the local drug supervision and administration department when discovering counterfeit and substandard drugs and drugs of questionable quality may be subject to Give a warning or impose a fine of RMB 2,000 to RMB 20,000; if the found counterfeit and inferior drugs are sold, returned or exchanged, they will be punished in accordance with the provisions of the "Drug Administration Law" on the sale of counterfeit and inferior drugs; if the counterfeit and inferior drugs are of suspicious quality, If a drug is sold, returned or exchanged, causing the drug supervision and administration department to be unable to trace it, it shall be dealt with in accordance with the provisions of Article 47 of these Measures.
Article 44 Violation of Articles 12, 17, 18, 19, 20, 21, and 35 of these Measures Article 52 shall be punished in accordance with the provisions of Article 52 of the Drug Administration Law.
Article 45 Domestic sales agents of imported drugs who fail to register and engage in domestic distribution of imported drugs shall be given a warning or a fine of RMB 10,000 to RMB 30,000.
Article 46 Anyone who violates the provisions of these Measures by distributing or using imported drugs without registration certificates and inspection reports, or who forges or alters imported drug registration certificates or drug inspection reports, shall be punished in accordance with the "Drug Administration Law" "Article 50" and Article 48 of the "Measures for the Implementation of Drug Administration".
Distribution of imported drugs fails to affix the official seal of the supplier on the copies of the imported drug registration certificate and inspection report as required, and fails to obtain the "Imported Drug Registration Certificate" and imported drug inspection report as required. , may be given a warning or a fine of not more than 10,000 yuan.
Article 47 Anyone who violates other provisions of these Measures shall be given a warning or a fine of not more than 10,000 yuan.
Article 48 When imposing administrative penalties, the drug regulatory department shall order the parties concerned to correct or cease illegal acts in accordance with their powers.
The superior drug regulatory department has the right to order the lower drug regulatory department to correct its improper administrative behavior.
Article 49 When implementing these Measures, the drug regulatory authorities are strictly prohibited from abusing their powers, engaging in malpractice for personal gain, and derelict in their duties. If the drug regulatory department and its drug supervisory personnel engage in the above-mentioned behaviors, the main person in charge and those directly responsible shall be severely dealt with in accordance with relevant regulations. If a crime is constituted, criminal liability shall be investigated in accordance with the law.
Article 50 If the parties concerned are dissatisfied with the administrative penalties imposed by the drug regulatory authorities in accordance with these Measures, they may apply for administrative reconsideration or initiate administrative litigation in accordance with the provisions of relevant laws and regulations.
Chapter 7 Supplementary Provisions
Article 51 The meanings of the following terms in these Measures are:
Drug bazaar: refers to illegal activities expressly prohibited by the state Places engaged in drug purchase and sale activities, including unapproved drug trade fairs. It is a place where multiple unlicensed operators, operators borrowing the protection of legal enterprises, or licensed off-site operators conduct relatively centralized independent and decentralized drug spot purchase, warehousing, storage, transportation, and sales activities.
Domestic sales agents of imported drugs: refer to corporate legal persons who have obtained the "Pharmaceutical Business Enterprise License" and are engaged in domestic sales agents of imported drugs based on the agreements signed with foreign pharmaceutical manufacturers. business pharmaceutical operating enterprises.
Off-site operation: refers to unauthorized change of the original registration location of the "Pharmaceutical Business Enterprise License" to engage in pharmaceutical business activities.
Business scope: refers to the scope of business varieties stipulated in the "Pharmaceutical Business Enterprise License".
The violations of drug approval number provisions stipulated in Article 7, Item 6 of these Measures refer to behaviors that do not constitute counterfeit and substandard drugs according to legal provisions.
The purchase and sale of drugs mentioned in Article 2 of these Measures does not include the purchase and sale of drugs by individuals.
The term “individual medical practitioners and individual clinics in cities and towns” as mentioned in these Measures does not include individual medical practitioners and clinics in rural areas.
The cities in these measures refer to prefecture-level cities in administrative divisions, excluding county-level cities.
Article 52 The contents related to the classification management of drugs stipulated in these Measures shall be implemented after the implementation of the "Measures for the Classification Management of Prescription Drugs and Over-the-Counter 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 Food and Drug Administration is responsible for the interpretation of these Measures.
Article 55 These Measures shall come into effect on August 1, 1999.
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"Regulations on the Implementation of the Drug Administration Law of the People's Republic of China"
People's Republic of China Regulations for the Implementation of the Drug Administration Law of the People's Republic of China
Chapter 1 General Provisions
Article 1 In accordance with the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as "Drug Administration Law") Law), formulates these regulations.
Article 2 The drug regulatory department of the State Council shall establish a national drug inspection agency.
The drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government may set up drug inspection institutions within their respective administrative regions. The plan for the establishment of local drug inspection agencies shall be proposed by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government, and shall be submitted to the people's government of the province, autonomous region, or municipality directly under the Central Government for approval.
The drug regulatory departments of the State Council and the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government may, as needed, determine inspection institutions that meet the conditions for drug inspection to undertake drug inspection work.
Chapter 2 Management of Pharmaceutical Manufacturing Enterprises
Article 3 To establish a pharmaceutical manufacturing enterprise, a "Drug Production License" shall be obtained in accordance with the following provisions:
(1) ) The applicant shall submit an application to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the proposed enterprise is located. The drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall, within 30 working days from the date of receipt of the application, conduct an examination in accordance with the national pharmaceutical industry development plan and industrial policy, and make a decision on whether to agree to the establishment.
(2) After the applicant completes the preparation of the proposed enterprise, it shall apply to the original approval department for acceptance. The original examination and approval department shall, within 30 working days from the date of receipt of the application, organize an acceptance inspection in accordance with the opening conditions stipulated in Article 8 of the Drug Administration Law; if the inspection is qualified, a "Drug Production License" will be issued. The applicant shall go to the industrial and commercial administration department to register in accordance with the law with the "Drug Production License".
Article 4 If a pharmaceutical manufacturing enterprise changes the permitted items of the "Drug Production License", it shall apply to the original issuing authority for registration of change in the "Drug Production License" 30 days before the change of the permitted items; without approval , the permission matters shall not be changed. The original issuing authority shall make a decision within 15 working days from the date of receipt of the application. The applicant shall go to the industrial and commercial administration department to handle the change registration procedures in accordance with the law with the changed "Drug Production License".
Article 5 The drug regulatory department of the people's government at or above the provincial level shall organize the certification of drug manufacturers in accordance with the "Good Manufacturing Practice for Drugs" and the implementation methods and implementation steps prescribed by the drug regulatory department of the State Council. ; If it complies with the "Good Manufacturing Practice for Drugs", a certification certificate will be issued. Among them, the drug regulatory department of the State Council is responsible for the certification of pharmaceutical manufacturing enterprises that produce injections, radioactive drugs, and biological products specified by the State Council’s drug regulatory department.
The format of the "Good Manufacturing Practice for Pharmaceutical Products" certification certificate is uniformly stipulated by the drug regulatory department of the State Council.
Article 6 If a newly established pharmaceutical manufacturing enterprise or a pharmaceutical manufacturing enterprise builds a new pharmaceutical production workshop or adds new production dosage forms, it shall, within 30 days from the date of obtaining the pharmaceutical production certification document or being approved for formal production, in accordance with the regulations. Apply to the drug regulatory department for "Good Manufacturing Practice" certification. The drug regulatory department that accepts the application shall, within 6 months from the date of receipt of the enterprise's application, organize the certification of whether the applicant enterprise complies with the "Good Manufacturing Practice for Drugs"; if the certification is qualified, a certification certificate will be issued.
Article 7 The drug regulatory department of the State Council shall establish a database of "Good Manufacturing Practices for Pharmaceutical Products" certification inspectors. "Good Manufacturing Practice" certification inspectors must meet the conditions specified by the drug regulatory department of the State Council. To carry out GMP certification, certification inspectors must be randomly selected from the GMP certification inspector pool to form a certification inspection team to conduct certification inspections in accordance with the regulations of the drug regulatory department of the State Council.
Article 8 The "Drug Production License" is valid for 5 years. If the validity period expires and it is necessary to continue to produce drugs, the license-holding enterprise shall apply for the replacement of the "Drug Production License" in accordance with the regulations of the drug regulatory department of the State Council 6 months before the expiration of the license.
If a drug manufacturing enterprise terminates the production of drugs or closes down, the "Drug Production License" shall be canceled by the original issuing department.
Article 9 The raw materials used by drug manufacturers to produce drugs must have a drug approval number or an imported drug registration certificate or a pharmaceutical product registration certificate issued by the drug regulatory department of the State Council; however, approval has not been implemented Except for Chinese herbal medicines and Chinese herbal medicine pieces managed by the license number.
Article 10 According to Article 13 of the "Drug Administration Law", when accepting entrustment to produce drugs, the entrusted party must hold a "Good Manufacturing Practice" certification that is appropriate for the drugs it is entrusted to produce. Certificate of pharmaceutical manufacturing enterprises.
Vaccines, blood products and other drugs specified by the State Council’s drug regulatory department shall not be commissioned for production.
Chapter 3 Management of Pharmaceutical Business Enterprises
Article 11 To establish a pharmaceutical wholesale enterprise, the applicant shall submit a request to the drug supervision and administration department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the proposed enterprise is located. Apply. The drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall make a decision on whether to agree to the establishment within 30 working days from the date of receipt of the application based on the establishment standards stipulated by the drug regulatory department of the State Council. After the applicant completes the preparation of the proposed enterprise, it shall apply to the original approval department for acceptance. The original approval department shall, within 30 working days from the date of receipt of the application, organize an acceptance inspection in accordance with the conditions for establishment stipulated in Article 15 of the Drug Administration Law; if the conditions are met, a "Drug Business License" shall be issued. The applicant shall go to the industrial and commercial administration department to register in accordance with the law with the "Drug Business License".
Article 12 To establish a drug retail enterprise, the applicant shall apply to the drug regulatory agency at the municipal level where the proposed enterprise is located or the county-level drug regulatory agency directly established by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government. The drug regulatory agency submits an application. The drug regulatory agency that accepts the application shall, within 30 working days from the date of receipt of the application, conduct an examination in accordance with the provisions of the drug regulatory department of the State Council, taking into account the local resident population, region, traffic conditions and actual needs, and make a decision whether to agree to the establishment. decision. After the applicant completes the preparation of the proposed enterprise, it should apply to the original approval agency for acceptance. The original approval agency shall, within 15 working days from the date of receipt of the application, organize acceptance inspection in accordance with the opening conditions stipulated in Article 15 of the "Drug Administration Law"; if the conditions are met, a "Drug Business License" will be issued. The applicant shall go to the industrial and commercial administration department to register in accordance with the law with the "Drug Business License".
Article 13 The drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for organizing the certification of drug operating enterprises. Pharmaceutical trading enterprises shall, in accordance with the implementation methods and implementation steps prescribed by the drug regulatory department of the State Council, pass the certification of the "Good Manufacturing Practice for Pharmaceutical Distribution" organized by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government, and obtain a certification certificate. The format of the "Good Manufacturing Practice for Pharmaceutical Products" certification certificate is uniformly stipulated by the drug regulatory department of the State Council.
Newly established drug wholesale enterprises and drug retail enterprises shall, within 30 days from the date of obtaining the "Pharmaceutical Business License", report to the drug regulatory department or the drug supervision and administration department that issued the "Pharmaceutical Business License". The management agency applies for "Good Manufacturing Practice for Pharmaceutical Products" certification. The drug regulatory agency that accepts the certification application of a drug retail enterprise shall, within 7 working days from the date of receipt of the application, transfer the application to the drug regulatory department of the people's government of the province, autonomous region, or municipality directly responsible for organizing the certification of drug operating enterprises. The drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall, within 3 months from the date of receipt of the certification application, and in accordance with the provisions of the drug regulatory department of the State Council, organize a review of whether the drug wholesale enterprise or drug retail enterprise applying for certification complies with the "Drug Regulations" "Business Quality Management Standards" shall be certified; if the certification is passed, a certification certificate will be issued.
Article 14 The drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall establish a database of "Good Manufacturing Practices for Pharmaceutical Distribution" certification inspectors. "Good Manufacturing Practice for Pharmaceutical Products" certification inspectors must meet the conditions specified by the drug regulatory department of the State Council.
To carry out the "Good Manufacturing Practice for Pharmaceutical Products" certification, certification inspectors must be randomly selected from the "Good Manufacturing Practice for Pharmaceutical Manufacturing Practice" certification inspector pool to form a certification inspection team to conduct certification inspections in accordance with the provisions of the drug regulatory department of the State Council.
Article 15 The state implements a classified management system for prescription drugs and non-prescription drugs. The state classifies over-the-counter drugs into Category A over-the-counter drugs and Category B over-the-counter drugs based on their safety.
Drug retail enterprises that operate prescription drugs and Class A over-the-counter drugs shall be equipped with licensed pharmacists or other pharmaceutical technicians who have been qualified in accordance with the law. Drug retail enterprises that operate Class B over-the-counter drugs shall have business personnel who have passed the assessment organized by the drug regulatory agency at the districted city level or the county-level drug regulatory agency directly established by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government.
Article 16 If a pharmaceutical business enterprise changes the permitted items of the "Pharmaceutical Business License", it shall apply to the original license-issuing authority for registration of change in the "Pharmaceutical Business License" 30 days before the change of the permitted items; Approval, no changes to the permitted items are allowed. The original issuing authority shall make a decision within 15 working days from the date of receipt of the enterprise's application. The applicant shall go to the industrial and commercial administration department to handle the change registration procedures in accordance with the law with the changed "Drug Business License".
Article 17 The "Drug Business License" is valid for 5 years. If the validity period expires and it is necessary to continue to operate drugs, the license-holding enterprise shall apply for the replacement of the "Drug Business License" in accordance with the regulations of the drug regulatory department of the State Council 6 months before the expiration of the license.
Pharmaceutical operating companies