Other relevant departments of the people's governments at or above the county level, in accordance with their respective responsibilities, to do a good job in the supervision and management of health supplies. Article V encourages and supports the production of health supplies research and development of new products, promote innovation, improve product quality, and promote the standardized management of health supplies production enterprises. Article health supplies to implement the certificate of approval system and category catalog management system. Jilin Province, health supplies approval certificate issued by the provincial health administrative department.
Units and individuals who have not obtained the "Certificate of Approval for Health Products in Jilin Province" shall not engage in the production of health products.
The categories of health supplies catalog determined by the provincial health administrative department, and promptly announced to the public. Article 7 The production enterprises of health care products shall have the following sanitary conditions:
(1) the production enterprises are built in the clean area, and keep the distance with the toxic and harmful places in accordance with the legal sanitary requirements;
(2) the plant shall be strong and clean, and the ceiling, wall and floor of the workshop shall be made of bright and clean building materials, and the lighting or illumination is good, and there are the facilities and measures for preventing and eliminating the conditions of rodent and mosquito breeding;
(c) with product variety, quantity appropriate to the health supplies raw materials, processing, packaging, storage and other plants or premises;
(d) production workshop production facilities suitable for the characteristics of the product, the process meets the hygiene requirements;
(e) health supplies to be processed in the workshop, raw materials, finished products shall not be cross-contaminated to avoid the finished product contact with unclean materials, toxic substances, or other toxic substances. Finished products contact with unclean and toxic substances;
(f) other conditions stipulated by laws and regulations. Article 8 The units and individuals applying for the "Certificate of Approval for Health Care Products in Jilin Province" must have the sanitary conditions stipulated in Article 7 of these Measures and submit the following materials to the provincial health administrative department:
(1) three copies of the application form;
(2) the basis for the production of the product, the formula, the structure or principle of manufacture, the production process and quality standards;
(3) the raw materials and product safety evaluation report;
(4) the product safety evaluation report;
(5) the raw materials and products and product safety evaluation report;
(d) product health function evaluation report;
(e) product samples;
(f) product labels and product instructions for review of samples;
(vii) provincial health administrative department issued by the site health license (copy);
(viii) the use of the population's health care function effect (h) the use of population health effects, 50 cases of sampling results report;
(ix) the administrative department for industry and commerce issued by the "pre-approval of enterprise name";
(j) a copy of the qualification certification of testing organizations. Article IX of the provincial health administrative department shall receive the application materials from the date of completion within 10 working days. Meet the conditions, be approved and issued a certificate of approval; does not meet the conditions, not approved, explain the reasons, and notify the applicant in writing.
Applicants to obtain the "Jilin Province, the certificate of approval of health supplies", the need to change the scope of business, but also to the original approval of the registration of the administrative department for industry and commerce for the change in scope of business procedures. Article X "Jilin Province, health supplies approval certificate" is valid for four years. Article XI of health supplies should be tested according to law.
Testing by the statutory testing organizations, the applicant can voluntarily choose to have the qualification of the testing organization to test health supplies. Article XII qualified testing organizations in accordance with the law to engage in health care products testing, should be in accordance with the technical specifications for the inspection and evaluation of health care products, health care products are in line with product standards and safety testing.
The results of the test, the testing organization shall issue a test report, the test report issued, the testing organization shall ensure that the test data and conclusions of the objective and fair, shall not issue false test reports. Article 13 The applicant has objections to the test report, you can receive the test report within five working days from the date of application to the Health Products Review Committee for re-testing. The Review Committee shall within 10 working days to re-select a testing organization testing. Article XIV provincial health administrative departments set up by the relevant experts in health care products review committee, responsible for the province's health care products efficacy, health standards and safety assessment, the review report.
Health care products review committee members from the medical, toxicology, nutrition, testing, pharmacology, medical devices, administration, standards and other relevant professional experts. Article XV of health care products approval authority, review committee, testing organizations shall not disclose the applicant's trade secrets. Article XVI to obtain the certificate of approval of health supplies outside the province units and individuals, in the administrative region of the province engaged in the production or sale of health supplies activities, should be filed to the provincial health administrative department.