Interim Measures for the Administration of Filing in Chinese Medicine Clinics
DecreeNo. fourteenth of the National Health and Family Planning Commission of the People’s Republic of China
The Interim Measures for the Record Management of Chinese Medicine Clinics was discussed and passed at the meeting of directors of the National Health and Family Planning Commission on July 31, 2017. It is hereby promulgated and shall come into force as of December 1, 2017.
Director Li Bin
September 22, 2017
Interim Measures for the Administration of Filing in Chinese Medicine Clinics
Chapter I General Provisions
Article 1 In order to do a good job in the filing management of Chinese medicine clinics, these Measures are formulated in accordance with the relevant provisions of the Chinese Medicine Law of People’s Republic of China (PRC) and the Regulations on the Administration of Medical Institutions.
Article 2 The Chinese medicine clinics referred to in these Measures refer to clinics in pharmacy service that use Chinese medicine and non-drug therapies such as acupuncture, cupping and massage, as well as Chinese medicine dispensing and decoction. These measures are not applicable to those who do not meet the service scope specified above or have uncontrollable medical safety hidden dangers and risks.
Article 3 state administration of traditional chinese medicine is responsible for the management of Chinese medicine clinics throughout the country.
The local competent departments of traditional Chinese medicine at or above the county level shall be responsible for the supervision and management of traditional Chinese medicine clinics within their respective administrative areas.
The competent department of traditional Chinese medicine at the county level shall be responsible for the filing work of traditional Chinese medicine clinics within their respective administrative areas.
Chapter II Filing
Article 4 Where a Chinese medicine clinic is held, the practice can be carried out after reporting to the county-level Chinese medicine department where the clinic is to be held for the record.
Article 5 A Chinese medicine clinic shall meet the following conditions:
(1) An individual who runs a clinic of traditional Chinese medicine shall have the Qualification Certificate of Chinese Medicine and have been practicing in medical, preventive and health care institutions for three years after registration, or have the Qualification Certificate of Chinese Medicine (Specialty); Where a legal person or other organization holds a Chinese medicine clinic, the main person in charge of the clinic shall meet the above requirements;
(two) in line with the "basic standards of Chinese medicine clinics";
(three) the name of the Chinese medicine clinic conforms to the relevant provisions of the Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions;
(four) in accordance with the relevant provisions of environmental protection and fire protection;
(5) Being able to bear civil liability independently.
The Detailed Rules for the Implementation of the Regulations on the Administration of Medical Institutions stipulates that no unit or individual may apply for the establishment of a medical institution or hold a Chinese medicine clinic.
Article 6 A Chinese medicine clinic shall submit the following materials for filing:
(a) "Chinese medicine clinic for the record information form";
(two) the valid identity certificate, doctor qualification certificate and doctor practice certificate of the main person in charge of the Chinese medicine clinic;
(3) Directory of other health technical personnel, valid identity certificates and qualification certificates;
(four) the management rules and regulations of Chinese medicine clinics;
(five) the medical waste treatment plan and the description of the surrounding environment of the clinic;
(6) Fire emergency plan.
Where a legal person or other organization holds a Chinese medicine clinic, it shall also provide the qualification certificate of the legal person or other organization, the identity certificate of the legal representative or the identity certificate of the representative of other organization.
Article 7 Filing persons shall truthfully provide relevant materials and reflect the real situation, and be responsible for the authenticity of the substantive contents of their filing materials.
Article 8 After receiving the filing materials, the competent department of traditional Chinese medicine at the county level shall file the materials that are complete and meet the filing requirements, and issue the Registration Certificate of Chinese Medicine Clinic on the spot; If the materials are incomplete or do not meet the filing requirements, the filer shall be informed of all the contents that need to be corrected on the spot or within five days from the date of receiving the filing materials.
The state gradually promotes the informationization of the management of Chinese medicine clinics, and online application for filing can be implemented where conditions permit.
Article 9 A Chinese medicine clinic shall publicize the Registration Certificate of Chinese Medicine Clinic and the information of health technicians in a prominent position in the clinic.
Tenth Chinese medicine clinic personnel, name, address and other actual settings should be consistent with the "Chinese medicine clinic registration certificate" records.
Where the name, place, main person in charge, diagnosis and treatment subjects, technology and other filing matters of the Chinese medicine clinic change, it shall timely go to the original filing organ for filing the changed matters.
Article 11 It is forbidden to forge, sell, transfer or lend the Registration Certificate of Chinese Medicine Clinic.
Article 12 Chinese medicine clinics shall carry out diagnosis and treatment activities according to the recorded diagnosis and treatment subjects and techniques, strengthen the management of diagnosis and treatment behavior, medical quality and medical safety, and comply with the relevant provisions of prevention and control of technology-related infections in Chinese medicine.
Chinese medicine clinics should abide by laws and regulations when publishing medical advertisements, and it is forbidden to make false or exaggerated propaganda.
Article 13 The competent department of traditional Chinese medicine at the county level shall, within 20 days from the date of issuing the Record Certificate of Chinese Medicine Clinic, disclose the information of Chinese medicine clinics filed within its jurisdiction on its government website, so as to facilitate social inquiry and supervision, and timely submit the record information of Chinese medicine clinics within its jurisdiction to the competent department of traditional Chinese medicine at the next higher level. The competent department of traditional Chinese medicine at the next higher level shall conduct verification, and find that the record items that do not meet the provisions of these measures shall be corrected within thirty days.
Chapter III Supervision and Administration
Fourteenth local departments in charge of traditional Chinese medicine at or above the county level shall strengthen the supervision and management of the practice of traditional Chinese medicine clinics according to law, medical quality and safety, and clinic management.
Fifteenth county-level departments in charge of traditional Chinese medicine shall, within 30 days from the date of filing the Chinese medicine clinic, conduct on-site verification of the registered Chinese medicine clinic, verify the relevant materials, and regularly carry out on-site supervision and inspection.
Sixteenth in any of the following circumstances, the Chinese medicine clinic shall report to the local county-level Chinese medicine department, and the county-level Chinese medicine department shall cancel the record and make a timely announcement to the public:
(a) the Chinese medicine clinic has stopped practicing for more than one year;
(two) the main person in charge of the Chinese medicine clinic has his practice certificate revoked or has been investigated for criminal responsibility;
(three) the legal person or other organization that runs the Chinese medicine clinic is terminated according to law;
(4) Chinese medicine clinics voluntarily terminate their practice activities.
Seventeenth county-level departments in charge of traditional Chinese medicine should regularly organize the person in charge of Chinese medicine clinics to learn health laws and regulations, prevention and control of infection and infectious diseases in medical institutions, and promote the practice of Chinese medicine clinics according to law; Regularly organize practitioners to participate in continuing education to improve their professional and technical level.
Article 18 The competent department of traditional Chinese medicine at the county level shall establish a record system of bad practice behaviors in Chinese medicine clinics, record illegal operations, unreasonable charges, false propaganda, etc., and serve as an important basis for the supervision and management of Chinese medicine clinics.
Chapter IV Legal Liability
Article 19 Where the local competent department of traditional Chinese medicine at or above the county level fails to perform its duties as prescribed in these Measures, it shall be dealt with in accordance with the provisions of Article 53 of the Chinese Medicine Law if it meets the filing conditions but fails to issue the filing certificate in time or fails to inform the information of traditional Chinese medicine clinics that need to be supplemented within the prescribed time limit, and fails to carry out supervision and management according to law.
Article 20 Whoever, in violation of the provisions of these measures, practices without the record of the county-level competent department of traditional Chinese medicine shall be ordered by the county-level competent department of traditional Chinese medicine to make corrections, confiscate the illegal income, impose a fine of not more than 30,000 yuan, and announce relevant information to the society; Refuses to correct, shall be ordered to stop practicing activities, the person directly responsible shall not engage in Chinese medicine related activities within five years from the date of making the punishment decision.
Twenty-first submitted false filing materials to obtain the "Chinese medicine clinic registration certificate", the county-level Chinese medicine department shall order it to make corrections, confiscate the illegal income, impose a fine of not more than 30 thousand yuan, and announce relevant information to the public; Refuses to correct, shall be ordered to stop practicing activities and cancel the "Chinese medicine clinic registration certificate", and its directly responsible personnel shall not engage in Chinese medicine related activities within five years from the date of making the punishment decision.
Twenty-second in violation of the provisions of article tenth of these measures, the Chinese medicine clinic without changing the settings without filing or the actual settings are inconsistent with the items recorded in the Record Certificate of Chinese Medicine Clinic, and shall not carry out medical activities. To carry out medical activities without authorization, the competent department of traditional Chinese medicine at the county level shall order it to make corrections, give a warning and impose a fine of not less than ten thousand yuan but not more than thirty thousand yuan; If the circumstances are serious, it shall be ordered to stop practicing and cancel the Registration Certificate of Chinese Medicine Clinic.
Article 23 Whoever, in violation of the provisions of Article 11 of these measures, sells, transfers or lends the Registration Certificate of Chinese Medicine Clinic shall be ordered by the county-level Chinese medicine department to make corrections, given a warning and may be fined between 10,000 yuan and 30,000 yuan; If the circumstances are serious, it shall be ordered to stop practicing and cancel the Registration Certificate of Chinese Medicine Clinic.
Twenty-fourth Chinese medicine clinics to carry out medical activities beyond the scope of filing, the local county-level Chinese medicine department shall order it to make corrections, confiscate the illegal income, and impose a fine of not less than ten thousand yuan but not more than thirty thousand yuan. Under any of the following circumstances, it shall be ordered to stop practicing activities and cancel the Registration Certificate of Chinese Medicine Clinic, and the directly responsible person in charge shall not engage in management work in medical institutions within five years from the date of making the punishment decision:
(1) Having received administrative punishment for carrying out medical activities beyond the scope of filing;
(2) engaging in medical activities beyond the scope of filing and causing harm to patients;
(three) in violation of the provisions of these measures, causing other serious consequences.
Chapter V Supplementary Provisions
Twenty-fifth Chinese medicine clinic management requirements not specified in these measures shall be implemented in accordance with relevant laws and regulations and the relevant provisions of the state medical institutions management.
Twenty-sixth "Chinese medicine clinic for the record information form" and "Chinese medicine clinic for the record certificate" format by the state administration of traditional chinese medicine unified regulations.
Twenty-seventh Chinese medicine clinics that have been set up before the implementation of these measures meet the filing conditions stipulated in these measures, and can be managed in accordance with the requirements of the Regulations on the Administration of Medical Institutions or in accordance with the filing requirements before the expiration of the validity period of the Practice License of Medical Institutions; Other clinics that do not meet the filing conditions are still subject to examination and approval management in accordance with the requirements of the Regulations on the Administration of Medical Institutions.
Article 28 The time limit stipulated in these Measures shall be calculated in working days.
Article 29 These Measures shall come into force as of December 1, 2017.