[Return] Chapter I General Provisions
Article 1 This procedure is formulated to ensure fairness, impartiality and openness in the examination and approval of health-related products.
Article 2 Health-related products refer to the Food Hygiene Law of People's Republic of China (PRC), Regulations on Cosmetic Hygiene Supervision, Measures for the Administration of Health Food, Measures for the Supervision and Administration of Drinking Water Hygiene, Measures for the Administration of Disinfection and other products related to human health approved by the Ministry of Health according to other laws, regulations and rules.
Article 3 The examination and approval of health-related products includes inspection, acceptance, evaluation and approval.
Article 4 All health-related products that require preliminary examination by the provincial health administrative department according to the relevant laws and regulations of the state shall be reported to the Ministry of Health only after the preliminary examination by the provincial health administrative department where the product manufacturer is located.
For health-related products that have been approved by the Ministry of Health, when the applicant applies for changing or supplementing relevant contents, he shall first apply to the provincial health administrative department that made the preliminary examination decision, and then declare to the Ministry of Health after the preliminary examination.
Imported health-related products are directly declared to the Ministry of Health.
Article 5 The inspection institutions for health-related products recognized by the Ministry of Health (hereinafter referred to as inspection institutions) shall undertake the inspection of health-related products in accordance with relevant national laws and regulations.
Article 6 The health-related product evaluation institution established by the Ministry of Health (hereinafter referred to as the evaluation institution) undertakes the acceptance of health-related products assigned by the Ministry of Health, related work of evaluation meetings, product approval, feedback of approval conclusions, and file management.
Article 7 The Evaluation Committee of various health-related products of the Ministry of Health (hereinafter referred to as the Evaluation Committee) shall undertake the corresponding technical evaluation of health-related products in accordance with relevant national laws and regulations.
Eighth units and personnel involved in the examination and approval of health-related products shall, in accordance with the division of labor, do a good job within their respective responsibilities and bear corresponding responsibilities.
Article 9 Fees involved in the examination and approval of health-related products shall be approved by relevant government departments. Without approval, no unit or individual may charge any fees without authorization or in disguised form.
Article 10 Inspection institutions and evaluation institutions shall announce to the public the acceptance time, application requirements, application procedures, working hours and charging standards, and provide consulting services related to the application.
Article 11 The examination and approval of health-related products shall be conducted in strict accordance with relevant national laws, regulations, rules and standards. Questions that are not clear in the examination and approval work should be asked for instructions from the relevant competent departments in a timely manner.
Twelfth units involved in the examination and approval work should establish various work registration systems, and the handover of relevant materials and samples should be recorded on the handover form and classified into product files for future reference.
[Return] Chapter II Inspection
Article 13 Inspection institutions shall carry out their work in accordance with the Working System of Inspection Institutions for Health-related Products.
Article 14 When applying for inspection, an inspection unit shall fill in the Application Form for Inspection of Health-related Products of the Ministry of Health, which shall be complete and clear and shall not be altered. The application form is in duplicate, one for the inspection institution and one for the applicant.
Article 15 When an inspection agency receives samples, the receiving party shall check the samples and related materials sent by the inspection unit in accordance with regulations. If it is verified to be consistent with the application form, the recipient shall sign the Application Form for Inspection of Health-related Products of the Ministry of Health and issue the Notice of Acceptance for Inspection of Health-related Products of the Ministry of Health. The acceptance notice is in duplicate, one for the inspection institution and one for the applicant. The acceptance notice shall be stamped with the official seal of the inspection agency.
Sixteenth inspection items and inspection methods should meet the requirements of relevant national laws, regulations and standards.
Article 17 After accepting samples, an inspection agency shall issue an inspection report within the prescribed time limit. The inspection report shall be standardized and conform to the requirements of relevant laws and regulations.
Eighteenth units that apply for inspection shall receive the inspection report with the Notice of Acceptance of Inspection of Health-related Products. Upon receipt of the inspection report, the inspection applicant shall sign the inspection report registration form issued by the inspection institution.
Article 19 When applying for an inspection unit to declare products, it shall attach the Application Form for Inspection of Health-related Products of the Ministry of Health and the Notice of Acceptance of Inspection of Health-related Products of the Ministry of Health to the inspection report and submit it to the evaluation institution.
[Return] Chapter III Preliminary Review
Twentieth provincial health administrative departments shall, after accepting the declaration of health-related products, make a preliminary conclusion within the time limit prescribed by laws and regulations, and affix the official seal of the health administrative department.
Twenty-first, the legality, completeness and standardization of the application materials shall be reviewed in accordance with the relevant provisions.
Twenty-second provincial health-related product inspection institutions recognized by the provincial health administrative department shall undertake the corresponding health-related product inspection work in accordance with relevant national laws and regulations.
Twenty-third provincial health-related product evaluation institutions undertake the preliminary examination of health-related products assigned by the provincial health administrative department.
Twenty-fourth provincial health administrative departments shall organize the establishment of provincial health-related product review committees, and all kinds of provincial health-related product review committees shall undertake the technical review of the corresponding health-related products in the preliminary stage according to relevant national laws and regulations, and issue review reports. The review report shall be signed by the chairman (or vice chairman) and the review committee. If the members of the bid evaluation committee hold different opinions on the bid evaluation conclusion, they shall explain it in the bid evaluation report.
Twenty-fifth products that have not been preliminarily examined in accordance with relevant regulations will not be accepted by the Ministry of Health.
[Return] Chapter IV Declaration and Acceptance
Twenty-sixth accreditation bodies shall, according to the needs of the work, designate special personnel to undertake the following tasks respectively:
Declaration and acceptance: responsible for accepting product declarations, reviewing materials and submitting the list of accepted products;
Work related to the review meeting: responsible for the preparation and sorting of materials related to the review meeting and its work.
Product approval: responsible for reporting product information after the review meeting;
Feedback of examination and approval conclusion: responsible for feeding back the examination and approval conclusion to the product declaration unit, including the production and distribution of hygiene license documents.
File management: responsible for information, file management and query.
Twenty-seventh reporting units to declare products, should fill in the "Ministry of health health related products declaration application form". The application form shall be complete and clear, and shall not be altered.
Twenty-eighth when receiving the application materials, the accreditation body shall check the application materials and samples submitted by the applicant in accordance with the provisions. If it is verified to be in conformity with the application form, the recipient shall sign the Application Form for Health-related Products of the Ministry of Health and affix the official seal of the evaluation agency. Application Form for Health-related Products of the Ministry of Health in duplicate, one for the applicant and one for the certification body. After the product is accepted, the evaluation institution shall store the "Application Form for Health-related Products of the Ministry of Health" in the product file for future reference.
Article 29 The accreditation body shall make a decision on whether to accept or not within 5 working days from the date of receiving the product application materials.
Thirtieth accreditation bodies shall, in accordance with the relevant provisions, review the legality, completeness and standardization of the application materials, and put forward written audit opinions, which shall be signed by the auditors and reviewers.
Thirty-first after examination, the evaluation institution shall issue the Notice of Acceptance of Health-related Products of the Ministry of Health to the applicant for products that meet the acceptance requirements. The acceptance notice is made in duplicate, one for the unit and one for the product file for future reference. The acceptance notice shall be stamped with the official seal of the authorized institution, and the recipient of the authorized institution shall sign the stub of the acceptance notice.
For products that do not meet the acceptance requirements, the evaluation institution shall issue a Notice of Non-acceptance of Health-related Products of the Ministry of Health to the applicant, which shall specify the contents that need to be revised and supplemented, and affix the official seal of the evaluation institution.
Thirty-second accreditation bodies shall return the failed application materials and product samples to the applicant. Upon receipt of the returned application materials and samples, the reporting unit shall sign the stub of the Notice of Non-acceptance of Health-related Products of the Ministry of Health.
Thirty-third reporting units shall, within five working days from the date of application, receive the notice of whether the application form for health-related products of the Ministry of Health accepts the products to be declared, and the overdue review institutions shall not handle it.
After receiving the notice, the applicant shall return the Application Form for Health-related Products of the Ministry of Health to the evaluation institution.
Thirty-fourth evaluation institutions shall promptly include the products that have passed the acceptance in the list of products that have passed the acceptance. The list shall include the acceptance date, acceptance number, product name, reporting unit and production enterprise, etc. , and should be arranged in the order of acceptance.
Article 35 The accreditation body shall submit to the Ministry of Health a list of accepted products and related topics to be submitted to the accreditation meeting for discussion at the end of each month. Without the approval of the Ministry of Health, no one may change the products submitted to the review meeting and the topics discussed without authorization.
Thirty-sixth of the products submitted to the review meeting for review, according to the relevant provisions, the review committee believes that it is necessary to modify the supplementary information before the review, it shall submit written opinions to the review body.
Article 37 The review institution shall complete the data review of the products that have been withdrawn from the review within 5 working days after the end of this review meeting, and notify the reporting unit of the review opinions in the form of the Notice of the Ministry of Health on the Review Opinions of Health-related Products.
Article 38 When receiving the revised supplementary data sent by the applicant, the evaluation institution shall issue the Receiving Sheet for Revised Supplementary Data of Health-related Products of the Ministry of Health, which shall be signed by the sender of the applicant's data and the recipient of the evaluation institution, and stamped with the official seal of the evaluation institution.
Thirty-ninth review institutions shall, within 5 working days from the date of receiving the revised supplementary information of the reporting unit, complete the data review in accordance with the relevant provisions. Products that meet the requirements after review will be reviewed at the next review meeting. For products that do not meet the requirements, the evaluation institution shall notify the reporting unit of the audit opinions in the form of Notice of Audit Opinions on Modification and Supplementary Information of Health-related Products of the Ministry of Health.
[Return] Chapter V Review Meeting Related Work
Fortieth within two weeks after the third month of each quarter, a review meeting of various health-related products will be held, and the products accepted before the end of the second month of each quarter will be reviewed by the quarterly review meeting.
Article 41 The Ministry of Health shall establish an expert database for evaluating health-related products. Before each review meeting, the Ministry of Health determines the specific date and place of the review meeting according to the number of products accepted, and informs some experts to participate in the review meeting according to the needs of the work to form various health-related product review committees.
Article 42 After receiving the notice of the meeting, the review committee shall attend the review meeting on time. In case of special circumstances, if you can't attend the meeting on time or need to ask for leave during the meeting, you should ask for leave in writing to the Ministry of Health in advance.
Article 43 During the review meeting, the review institution shall prepare the list of products to be reviewed, relevant application materials, product samples and the review record book of the review committee on that day in the order of the list of accepted products submitted to the Ministry of Health before the meeting.
Article 44 During the review meeting, the review committee shall use the Review Work Record Book to record the relevant review work. When the meeting is not in session, the work record book shall be kept by the accreditation body.
Article 45 The evaluation committee shall, in accordance with relevant regulations, conduct technical evaluation on products in the order of product list, and complete the evaluation report.
Forty-sixth during the review meeting, the review agency is responsible for printing the review report in time as required, completing the matters assigned by the review Committee and doing a good job in the review meeting.
Forty-seventh during and after the review meeting, the review institution shall timely sort out the review materials. All evaluation materials shall be properly kept and handled, and shall not be leaked.
Forty-eighth after the review meeting, for the products that are recommended for approval after supplementary information and re-evaluated by the General Assembly after supplementary information, the review institution shall timely complete the Notice of the Ministry of Health on the Review Opinions of Health-related Products.
Article 49 For products recommended for approval after supplementary information, the evaluation institution shall, within 10 working days from the date of receiving the revised supplementary information submitted by the applicant, notify the designated members of the evaluation committee to review the revised supplementary information in accordance with relevant regulations.
For products that have passed the review by the General Assembly after supplementary information, the review institution shall complete the data review within 5 working days from the date of receiving the revised supplementary information submitted by the reporting unit. Products that meet the requirements after examination shall be included in the list of acceptance products in time. Do not meet the requirements of the product, the accreditation body shall notify the reporting unit of the audit opinion in the form of "Notice of the Ministry of Health on the audit opinion of health-related products".
[Return] Chapter VI Product Approval and Recognition
Article 50 After the review meeting 10 working days, the review institution shall report the products that are "recommended for approval" and "recommended for disapproval" to the Ministry of Health according to the order of the list of accepted products submitted to the Ministry of Health before the meeting.
Article 51 The Ministry of Health shall, after receiving the approval materials of health-related products reported by the authorized institutions, put forward opinions on the treatment of products that cannot be approved due to existing problems, and make a decision on whether to approve other products within the time limit prescribed by relevant laws and regulations.
Fifty-second for products that cannot be approved due to problems and products that have not been approved by the Ministry of Health, the evaluation institution shall fill in the Notice of Evaluation Opinions on Health-related Products of the Ministry of Health in a timely manner.
[Return] Chapter VII Feedback of Approval Conclusion
Article 53 An evaluation institution shall, within 5 working days from the date of approval of health-related products by the Ministry of Health, complete the approval document or certificate of hygiene license (hereinafter referred to as the approval document of hygiene license) and notify the applicant to collect it.
Article 54 Before each health permit document is sent to the applicant, it shall be checked by the printer, proofreader and document issuer of the evaluation institution. A registration system should be established for the production and distribution of health permit documents.
Fifty-fifth health-related products hygiene license approval in duplicate, one stamped with the official seal of the Ministry of Health and sent to the reporting unit, and the other filed in the product file for future reference.
Fifty-sixth reporting units shall receive the approval documents of health license with the Notice of Acceptance of Health-related Products of the Ministry of Health. When the applicant receives the health permit, he shall return the Notice of Acceptance of Health-related Products of the Ministry of Health to the evaluation institution, and sign the Registration Form of Health Permit Issuance of the Evaluation Institution. The evaluation institution shall file the Notice of Acceptance of Health-related Products of the Ministry of Health and the Registration Form for Issuance of Health Permit Documents returned by the reporting unit in the product files for future reference.
Article 57 The catalogue of health-related products approved by the Ministry of Health shall be published once a month by the Ministry of Health in the form of an announcement. The evaluation institution shall complete the delivery of the notice of the Ministry of Health within 2 working days from the date of issuance of the notice.
Fifty-eighth health-related products that have not been approved by the Ministry of Health shall be notified to the reporting unit by the competent department of the Ministry of Health. The evaluation institution shall, within 5 working days from the date of receiving the conclusion of examination and approval from the Ministry of Health, notify the reporting unit of the conclusion of examination and approval from the Ministry of Health together with the Notice of Evaluation Opinions on Health-related Products of the Ministry of Health.
Fifty-ninth according to the evaluation opinions of the evaluation committee, the products that need to modify the supplementary information shall be notified to the reporting unit by the evaluation institution. For the products recommended for approval after supplementary information and reviewed by the General Assembly after supplementary information, the evaluation institution shall, within 7 working days from the end of the evaluation meeting, notify the reporting unit of the Notice of Evaluation Opinions of Health-related Products of the Ministry of Health.
Article 60 If the applicant disagrees with the review opinions, he may submit a written application for review to the competent department of the Ministry of Health within 15 days from the date of receiving the review opinions. When applying for review, it shall submit the Notice of the Ministry of Health for Soliciting Opinions on Health-related Products.
Article 61 For related products that have not been approved by the Ministry of Health, the reporting unit shall declare again after improvement, and re-apply for declaration in accordance with the relevant provisions of this procedure. When re-submitting the application materials, it shall also submit the notice of evaluation opinions of the original declared products and the reasons for re-declaration.
[Return] Chapter VIII File Management
Article 62 Relevant materials for examination and approval of health-related products shall be filed and properly kept. Among them, the original materials declared by the reporting unit and the review opinions of the review committee shall be filed by the review institution and sent to the archives room of the Ministry of Health for preservation, and the rest materials shall be filed by the review institution.
Article 63 When the appraisal meeting is not in session, the appraisal institution shall properly keep the appraisal record book of the members of the appraisal committee.
Article 64 A review institution shall establish a database for examination and approval of health-related products and provide retrieval and inquiry services.
Article 65 An evaluation institution shall properly keep the declared product samples submitted by the applicant, and the declared product samples shall be kept for 3 months after the conclusion of examination and approval made by the Ministry of Health.
[Return] Chapter IX Supplementary Provisions
Article 66 The Ministry of Health shall be responsible for the interpretation of these regulations.
Article 67 This procedure shall be implemented from 1 May 19991day. If the relevant provisions issued by the Ministry of Health in the past are inconsistent with these regulations, these regulations shall prevail.
1. When applying for a health permit, the applicant shall pay the examination fee according to the relevant domestic regulations.
2. The sterilization test and toxicology test shall be provided by the disinfection appraisal laboratory recognized by the Ministry of Health in accordance with the Technical Specification for Disinfection 199 165438 published by the Ministry of Health in February (the test report shall be valid only if it is signed by the inspection and auditing personnel, indicating my major and title, and stamped with the official seal of the inspection unit). If the product name or instructions indicate that it has disinfection effect on hepatitis or AIDS virus, relevant experimental data must be provided.
3, where the declaration can be used for food utensils and equipment disinfection, skin disinfection drugs should have the corresponding test data, after approval, will indicate in the "health permit" approval can be used for food utensils and equipment disinfection or skin disinfection.
4. Products that have obtained the "Hygiene Permit" with the approval number of the health administrative department of the government at or above the provincial level shall not exceed the approved scope of use or change the instructions and formulas when advertising, and shall be subject to the supervision, monitoring and management of the local health administrative department and health and epidemic prevention institutions.
5. This Hygiene Permit (original and copy) is valid for three years. Two months before the expiration, the product applicant must report to the department that issued the "Hygiene License" on the quality self-inspection of the products produced by the production unit and the monitoring and inspection report provided by the health and epidemic prevention institutions, so as to go through the formalities for replacement.
Six, the examination and approval procedures from the date of promulgation.