Supervision and management of health supplies required to be included in the financial budget at this level. Article V above the county level people's government food and drug supervision and management department in charge of supervision and management of health supplies in the administrative region.
Industrial and commercial administration, quality and technical supervision and other relevant departments in their respective areas of responsibility, is responsible for the supervision and management of health supplies related work. Article VI of this province to implement the approval and registration of health supplies management system and category catalog management system. Article VII health supplies industry associations should strengthen industry self-discipline, guide the production and operation of health supplies enterprises in accordance with the law, publicity, popularization of scientific knowledge of health supplies, to prevent false and exaggerated propaganda on health supplies, to promote the construction of corporate integrity, and safeguard the legitimate rights and interests of enterprises. Article VIII of health supplies production and management enterprises should strengthen the quality of target management, standardize production and management practices to ensure the safety and effectiveness of health supplies. Chapter II Registration of health supplies Article IX apply for registration of health supplies enterprises shall have the following conditions:
(a) a sound production and health management system;
(b) with professional and technical personnel to meet the requirements of;
(c) with health supplies in line with the requirements of the production of premises, facilities, equipment and sanitation environment;
(d) with a health care products that can be produced on the The production of health products raw materials, finished products for quality inspection of the premises, institutions or personnel and the corresponding inspection facilities. Article X enterprises to apply for registration of health care products, should be located in the area of the enterprise's municipal food and drug supervision and management department to apply, the municipal food and drug supervision and management department by the area of the initial examination, reported to the provincial food and drug supervision and management department for approval. Article XI of the enterprise to apply for registration of health products, should fill out the "Shaanxi Province, health products registration application form", submit the following information:
(a) product development reports, naming basis, product composition and basis or product structure and principle and other relevant information;
(b) product production process and the main technical parameters, plant, workshop, inspection room layout, the main instruments, Equipment list;
(C) product quality standards;
(D) product inspection reports and functional evaluation reports;
(E) product packaging, labeling and manual samples;
(F) business license of the manufacturer, proof of ownership of the production site, the production and inspection of professional and technical staffing and other materials. Article XII of the municipal food and drug supervision and management departments in the region after receiving the declaration of information within five days of the declaration of normality, completeness, legality of the review, and issue a written certificate of acceptance or inadmissibility.
The municipal food and drug supervision and management departments of the region on the acceptance of the declaration of information, should be reported to the provincial food and drug supervision and management departments within five days. Article XIII of the provincial food and drug supervision and management departments to receive registration information, within twenty days of the organization of professional production conditions, staff qualifications, facilities and equipment, quality management and other on-site verification.
On-site verification of qualified samples taken, sent to the inspection agency to review the test. Review test costs borne by the enterprise. Article XIV of the provincial food and drug supervision and management departments in accordance with the corresponding qualifications of the inspection agency to determine the health care products to undertake the registration of inspection, supervision and inspection of inspection agencies, and to the public.
Engaged in the registration of health products, supervision and inspection of testing organizations, shall not recommend the use of health products to the community. Article XV inspection agency engaged in health care products inspection, in accordance with the provincial food and drug supervision and management departments of health care products inspection and evaluation of technical specifications, health care products for safety, health care functionality and physical and chemical hygiene inspection, and issue inspection reports.
Health care products inspection agency for the issuance of test reports bear legal responsibility. Article XVI of the provincial food and drug supervision and management departments to receive product review and inspection of qualified reports, within twenty days of the organization held a meeting of the Review Committee on Health Care Products.
The Review Committee is responsible for the health products of the formula, structure, production process, quality requirements, health effects, safety and scientific technical review. Members of the evaluation committee to fulfill their duties, should be objective and fair, abide by professional ethics, keep commercial secrets, and bear legal responsibility for the evaluation opinion.
The evaluation committee consists of experts in medicine, pharmacy, optics, mechanics, electronics, electromagnetism, medical devices, standards and other related professions.
The evaluation committee meeting, as needed, can require the applicant company to provide relevant explanations and representations.