All drug and medical device business and use units, cosmetics business units:
In order to ensure the quality and safety of the masses of people using medicinal devices and cosmetics, the following reminders and warnings are hereby made to further standardize the quality management of drugs, medical devices and cosmetics in the high-tech zone.
1. Conscientiously abide by the laws, regulations and rules related to the quality management of drugs, medical devices and cosmetics.
All drug and medical device business and use units shall strictly abide by the "Drug Administration Law of the People's Republic of China", "Regulations on the Supervision and Administration of Medical Devices", "Regulations on the Supervision and Administration of Cosmetics", "Measures for the Supervision and Administration of Drug Operation and Use Quality", "Measures for the Administration of Adverse Drug Reaction Reporting and Monitoring", "Quality Management Standards for Drug Operation", "Quality Management Standards for Drug Use", "Quality Management Standards for Medical Device Operations" and other laws, regulations and rules, consciously enhance social responsibility, and strictly fulfill the procurement, acceptance, and acceptance of drugs, medical devices and cosmetics in accordance with the law. Storage-related obligations to ensure the quality, safety and compliance of drugs, medical devices and cosmetics.
2. The legal responsibility for the preparation of preparations without obtaining the "Preparation License for Medical Institutions".
In accordance with the provisions of Article 115 of the Drug Administration Law of the People's Republic of China, it shall be ordered to close down, confiscate the illegally produced drugs and illegal gains, and impose a fine of not less than 15 times but not more than 30 times the value of the illegally produced drugs (including sold and unsold drugs, the same below); If the value of the goods is less than 100,000 yuan, it shall be calculated as 100,000 yuan.
3. Legal liability for purchasing drugs from illegal channels.
In accordance with the provisions of Article 129 of the Drug Administration Law of the People's Republic of China, it shall be ordered to make corrections, confiscate the illegally purchased drugs and illegal gains, and impose a fine of not less than two times but not more than ten times the value of the illegally purchased drugs; where the circumstances are serious, a fine of between 10 and 30 times the value of the goods shall be imposed, and the practice license of the medical institution shall be revoked; If the value of the goods is less than 50,000 yuan, it shall be calculated as 50,000 yuan.
4. Legal responsibility for illegal operation and use of counterfeit drugs.
In accordance with the provisions of Articles 116 and 119 of the Drug Administration Law of the People's Republic of China, punishment shall be imposed in accordance with the provisions on the sale of counterfeit drugs, confiscation of illegally sold drugs and illegal gains, order the suspension of production and business for rectification, and impose a fine of not less than 15 times but not more than 30 times the value of the illegally sold drugs; If the value of the goods is less than 100,000 yuan, it shall be calculated as 100,000 yuan; If the circumstances are serious, the legal representative, principal responsible person, directly responsible managers and other responsible personnel shall have their income obtained from their unit during the period of the illegal act confiscated, and shall be fined not less than 30% but not more than three times the income obtained, and shall be prohibited from engaging in drug production and business activities for life, and may be detained by the public security organ for not less than 5 days but not more than 15 days. Where the legally-designated representative, principal responsible person, directly responsible person in charge and other responsible personnel have a medical and health personnel practice certificate, the practice certificate shall also be revoked.
5. Legal responsibility for the illegal operation and use of expired drugs and other inferior drugs.
In accordance with the provisions of Articles 117 and 119 of the Drug Administration Law of the People's Republic of China, punishment shall be imposed in accordance with the provisions on retail sale of inferior drugs, confiscation of illegally sold drugs and illegal gains, and a fine of not less than 10 times but not more than 20 times the value of the illegally sold drugs; where the value of illegally retailed drugs is less than 10,000 yuan, it is calculated as 10,000 yuan; If the circumstances are serious, the legal representative, principal responsible person, directly responsible managers and other responsible personnel shall have their income obtained from their unit during the period of the illegal act confiscated, and shall be fined not less than 30% but not more than three times the income obtained, and shall be prohibited from engaging in drug production and business activities for life, and may be detained by the public security organ for not less than 5 days but not more than 15 days. Where the legally-designated representative, principal responsible person, directly responsible person in charge and other responsible personnel have a medical and health personnel practice certificate, the practice certificate shall also be revoked.
6. Failure to perform quality management obligations such as purchase inspection, drug storage and maintenance, suspension of use, and reporting.
In accordance with the provisions of Article 73 of the Measures for the Supervision and Administration of the Quality of Drug Operation and Use, the drug regulatory department shall order the correction within a time limit and notify the competent health department; where corrections are not made within the time limit or the circumstances are serious, a fine of between 5,000 and 50,000 RMB is to be given; where serious consequences are caused, a fine of between 50,000 and 200,000 RMB is to be given.
7. Legal liability for failure to report suspected adverse drug reactions in accordance with regulations.
In accordance with the provisions of Article 134 of the Drug Administration Law of the People's Republic of China, it shall be ordered to make corrections within a time limit and given a warning; and where corrections are not made within the time limit, a fine of between 50,000 and 500,000 RMB is to be imposed.
8. Legal liability for the use of medical devices that do not meet the mandatory standards or the technical requirements of the products that have been registered or recorded, or the use of medical devices that do not have qualification certificates, expire, become invalid, or obsolete, or use medical devices that have not been registered in accordance with the law.
In accordance with the provisions of Article 86 of the Regulations on the Supervision and Administration of Medical Devices, it shall be ordered to make corrections and confiscate the medical devices used illegally; If the value of the medical device illegally used is less than 10,000 yuan, a fine of not less than 20,000 yuan but not more than 50,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of between 5 and 20 times the value of the goods shall be imposed; If the circumstances are serious, it shall be ordered to suspend production and business, and the legal representative, main responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall be confiscated from the income obtained during the period of the illegal act, and shall be fined not less than 30% but not more than 3 times of the income obtained, and shall be prohibited from engaging in medical device production and business activities for 10 years.
9. Legal liability for purchasing medical devices from suppliers who do not have legal qualifications, or failing to establish and implement a medical device purchase inspection system in accordance with the provisions of the Regulations on the Supervision and Administration of Medical Devices, or failing to establish and implement a product traceability system in accordance with the regulations, or failing to carry out regular inspection, inspection, calibration, maintenance, maintenance and recording in accordance with the requirements of the product manual, or failing to properly keep the original materials of the purchased Class III medical devices.
In accordance with the provisions of Article 89 of the Regulations on the Supervision and Administration of Medical Devices, it shall be ordered to make corrections and give warnings; where corrections are refused, a fine of between 10,000 and 100,000 RMB is to be given; If the circumstances are serious, it shall be ordered to suspend production and business until the medical device registration certificate, medical device production license, and medical device business license are revoked by the original licensing department, and the legal representative, main responsible person, directly responsible person in charge and other responsible personnel of the illegal unit shall be fined not less than 10,000 yuan but not more than 30,000 yuan.
10. Cosmetics business operators prepare cosmetics without authorization, or deal in cosmetics that have deteriorated or exceeded the expiration date; Legal liability for the production and operation of cosmetics that do not meet the mandatory national standards and technical specifications or the technical requirements specified in the cosmetics registration and filing materials.
In accordance with Article 60 of the Regulations on the Supervision and Administration of Cosmetics, confiscate illegal gains, cosmetics illegally produced and traded, and raw materials, packaging materials, tools, equipment and other items specially used for illegal production and operation; where the value of cosmetics illegally produced or traded is less than 10,000 yuan, a fine of between 10,000 and 50,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of between 5 and 20 times the value of the goods shall be imposed; if the circumstances are serious, it shall be ordered to suspend production and business, the filing department shall cancel the filing, or the original license issuing department shall revoke the cosmetics license, and the legal representative or main responsible person, directly responsible person in charge and other directly responsible personnel of the illegal unit shall be fined not less than 1 time but not more than 3 times the income obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and business activities for 10 years; where a crime is constituted, criminal responsibility is pursued in accordance with law.
11. Production and operation of cosmetics whose labels do not comply with regulations; Legal liabilities for selling, operating or importing ordinary cosmetics that have not been filed.
According to Article 61 of the Regulations on the Supervision and Administration of Cosmetics, the illegal income and illegal production and operation of cosmetics shall be confiscated, and the raw materials, packaging materials, tools, equipment and other items specially used for illegal production and operation may be confiscated; where the value of cosmetics illegally produced or traded is less than 10,000 yuan, a fine of between 10,000 and 30,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of between 3 and 10 times the value of the goods shall be imposed; If the circumstances are serious, it shall be ordered to suspend production and business, the filing department shall cancel the filing or the original license issuing department shall revoke the cosmetics license, and the legal representative or principal responsible person, directly responsible person in charge and other directly responsible personnel of the illegal unit shall be fined not less than 1 time but not more than 2 times the income obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and business activities for 5 years.
12. Production, operation or import of unregistered special cosmetics; Legal liabilities for engaging in cosmetics production activities without permission, or for cosmetics registrants or record-filing persons to entrust enterprises that have not obtained the corresponding cosmetics production license to produce cosmetics.
In accordance with Article 59 of the Regulations on the Supervision and Administration of Cosmetics, confiscate illegal gains, cosmetics illegally produced and traded, and raw materials, packaging materials, tools, equipment and other items specially used for illegal production and operation; where the value of cosmetics illegally produced or operated is less than 10,000 yuan, a fine of between 50,000 and 150,000 yuan shall be imposed; if the value of the goods is more than 10,000 yuan, a fine of between 15 and 30 times the value of the goods shall be imposed; if the circumstances are serious, it shall be ordered to suspend production and business, the filing department shall cancel the filing or the original license issuing department shall revoke the cosmetics license, and shall not handle the cosmetics filing or accept the cosmetics administrative license application submitted by the applicant within 10 years, and shall impose a fine of not less than 3 times but not more than 5 times the income obtained from the unit in the previous year, and shall be prohibited from engaging in cosmetics production and business activities for life; where a crime is constituted, criminal responsibility is pursued in accordance with law.
All pharmaceutical and medical device business units and cosmetics business units shall self-examine and self-correct according to the requirements, and temporarily store the expired drugs, medical devices, and cosmetics in the unqualified areas after registration, and hand them over to qualified units for processing. The High-tech Zone Bureau of Liupanshui Market Supervision and Administration will continue to strengthen the supervision and inspection of the quality of drugs, medical devices and cosmetics, and deal with violations of laws, regulations and rules such as the Drug Administration Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices, and the Regulations on the Supervision and Administration of Cosmetics in accordance with laws and regulations.
Liupanshui City Market Supervision and Administration Bureau High-tech Zone Bureau
June 15, 2024
Contributed by: Pharmaceuticals Unit
Editor: Chen Tongxin
Preliminary review: Huang Keshu
Re-examiner: Huang Hui
Final review: Yang Hong
Disclaimer: The pictures and text used in this article are part (or all) from the Internet, and only represent the author's point of view. It does not mean that this official account agrees with its views and is responsible for its authenticity, only providing reference does not constitute investment and application advice, the copyright belongs to the original author or institution, if there is any infringement, please contact to delete.