The funds required for the supervision and management of health care products are included in the fiscal budget at the corresponding level. Article 5 The food and drug supervision and administration department of the people's governments at or above the county level shall be responsible for the supervision and administration of health care products within their respective administrative areas.
Industrial and commercial administration, quality and technical supervision and other relevant departments are responsible for the supervision and management of health care products within their respective responsibilities. Article 6 This province implements the management system of examination and approval and registration of health care products and the management system of category catalogue. Article 7 health care industry Association shall strengthen industry self-discipline, guide enterprises engaged in the production and operation of health care products according to law, publicize and popularize scientific knowledge of health care products, prevent false and exaggerated publicity of health care products, promote the integrity building of enterprises and safeguard their legitimate rights and interests. Article 8 Enterprises engaged in the production and operation of health care products shall strengthen quality target management, standardize production and operation behaviors, and ensure the safety and effectiveness of health care products. Chapter II Registration of Health Care Products Article 9 An enterprise applying for registration of health care products shall meet the following conditions:
(1) Having a sound production hygiene management system;
(2) Having qualified professional and technical personnel;
(3) Having places, facilities, equipment and sanitary environment that meet the production requirements of health care products;
(4) Having places, institutions or personnel and corresponding inspection facilities that can inspect the quality of raw materials and finished products of health care products. Article 10 An enterprise applying for registration of health care products shall apply to the food and drug supervision and administration department of the city where the enterprise is located. The food and drug supervision and administration department of the city divided into districts shall conduct preliminary examination and report to the food and drug supervision and administration department of the province for examination and approval. Eleventh enterprises applying for the registration of health products shall fill in the Application Form for the Registration of Health Products in Shaanxi Province and submit the following materials:
(a) product development report, naming basis, product composition and basis or product structure and principle and other related information;
(two) the production process and main technical parameters of the product, the layout of the factory building, workshop and inspection room, and the list of main instruments and equipment;
(3) product quality standards;
(four) product inspection report and function evaluation report;
(5) Sample drafts of product packaging, labels and instructions;
(six) the business license of the production enterprise, the ownership certificate of the production site, and the allocation of professional and technical personnel for production and inspection. Article 12 The food and drug supervision and administration department of a city divided into districts shall, within five days after receiving the application materials, review the standardization, completeness and legality of the application materials, and issue a written certificate of acceptance or rejection.
The food and drug supervision and administration department of a city divided into districts shall report the accepted application materials to the provincial food and drug supervision and administration department within five days. Thirteenth provincial food and drug supervision and management departments shall, within twenty days after receiving the application materials for registration, organize professionals to conduct on-site verification of production conditions, qualifications of employees, facilities and equipment, quality management, etc. Of a manufacturing enterprise.
Samples that pass the on-site inspection shall be sent to the inspection agency for review and inspection. The cost of examination and inspection shall be borne by the enterprise. Fourteenth provincial food and drug supervision and management departments shall determine the inspection institutions that undertake the registration inspection, supervision and inspection of health care products among the inspection institutions that have obtained corresponding qualifications according to law, and announce them to the public.
Inspection institutions engaged in registration inspection, supervision and inspection of health care products shall not recommend the use of health care products to the society. Fifteenth inspection agencies engaged in health care products inspection, should be in accordance with the provincial food and drug supervision and management departments of health care products inspection and evaluation technical specifications, health care products for safety, health function and physical and chemical hygiene inspection, and issue inspection reports.
The health care product inspection institution shall bear legal responsibility for the inspection report issued. Sixteenth provincial food and drug supervision and management departments shall, within twenty days after receiving the product review and inspection report, organize a meeting of the health care product review committee.
The review committee is responsible for the technical review of the prescription, structure, production technology, quality requirements, health care efficacy, safety and scientificity of health care products. Members of the review committee shall perform their duties objectively and fairly, abide by professional ethics, keep business secrets, and bear legal responsibility for the review opinions.
The judging committee is composed of experts in medicine, pharmacy, optics, machinery, electronics, electromagnetism, medical devices, standard use and other related disciplines.
According to the needs, the review committee meeting may require the applicant to provide relevant explanations and statements.