Other relevant departments of the people's governments at or above the county level shall, in accordance with their respective duties, do a good job in the supervision and management of health care products. Article 5 Encourage and support health care product manufacturers to research and develop new products, promote enterprise innovation, improve product quality, and promote standardized management of health care product manufacturers. Article 6 Health products shall be subject to the approval certificate system and category catalogue management system. "Jilin province health care products approval certificate" issued by the provincial health administrative department.
Units and individuals that have not obtained the approval certificate of health care products in Jilin Province shall not engage in the production of health care products.
The catalogue of health care products shall be determined by the provincial health administrative department and announced to the public in a timely manner. Article 7 Enterprises producing health products shall meet the following sanitary conditions:
(a) the production enterprise is built in a clean area, and the distance from the toxic and harmful places meets the statutory hygiene requirements;
(2) The workshop should be firm and tidy, and the ceiling, walls and ground in the workshop should be made of bright and clean building materials, with good lighting or lighting, and facilities and measures to prevent and eliminate the breeding conditions of rodents and mosquitoes;
(3) Having factories or places where raw materials, processing, packaging and storage of health care products are suitable for the variety and quantity of products;
(four) the production workshop has production facilities suitable for the characteristics of the products, and the technological process meets the hygiene requirements;
(five) the health care products, raw materials and finished products processed in the production workshop shall not be cross-contaminated, so as to avoid the contact between the finished products and impurities and poisons;
(6) Other conditions stipulated by laws and regulations. Article 8 Units and individuals applying for the Approval Certificate of Health Care Products in Jilin Province must meet the hygiene conditions stipulated in Article 7 of these Measures, and submit the following materials to the provincial health administrative department:
(1) An application in triplicate;
(2) the production basis, formula, structure or manufacturing principle, production technology and quality standard of the product;
(three) the safety evaluation report of raw materials and products;
(four) the product health function evaluation report;
(5) product samples;
(6) Samples of product labels and product descriptions submitted for examination;
(seven) the on-site health permit issued by the provincial health administrative department (copy);
(eight) the effect of the user's health care function, and the results of 50 sample surveys;
(9) Notice of pre-approval of enterprise name issued by the administrative department for industry and commerce;
(ten) a copy of the qualification certificate of the testing institution. Article 9 The provincial health administrative department shall complete the application within 10 working days from the date of receiving the application materials. Meet the conditions, be approved, and issue a certificate of approval; Do not meet the conditions, shall not be approved, explain the reasons, and notify the applicant in writing.
If the applicant needs to change the business scope after obtaining the approval certificate of health care products in Jilin Province, it shall also go through the formalities for changing the business scope at the original administrative department for industry and commerce. Tenth "Jilin Province Health Products Approval Certificate" is valid for 4 years. Article 11 Health products shall be inspected according to law.
The testing work shall be undertaken by a statutory testing institution, and the applicant may voluntarily choose a qualified testing institution to test the health care products. Twelfth legally qualified testing institutions engaged in health care products testing, health care products should be tested and evaluated in accordance with technical specifications, and whether health care products meet product standards and safety.
For the test results, the testing institution shall issue a test report. For the test report issued, the testing institution shall ensure that the test data and conclusions are objective and fair, and shall not issue false test reports. Article 13 If the applicant has any objection to the test report, he may apply to the Health Products Review Committee for re-examination within 5 working days from the date of receiving the test report. The evaluation committee shall re-select the testing institution for testing within 10 working days. Fourteenth provincial health administrative departments set up a health care product evaluation committee composed of relevant experts, responsible for the efficacy, health standards and safety evaluation of health care products in this province, and issue an evaluation report.
The members of the Health Products Review Committee are composed of experts in medical treatment, toxicology, nutrition, inspection, pharmacology, medical devices, administration and standard use. Fifteenth health care products examination and approval authorities, review committee and testing institutions shall not disclose the business secrets of the applicant. Article 16 Units and individuals that have obtained the approval certificate of health care products outside the province and are engaged in the production or sale of health care products within the administrative region of this province shall file with the provincial health administrative department.