Article 1: In order to strengthen the supervision and management of health products, standardize and promote the development of the health products industry, and safeguard the legitimate rights and interests of consumers, these regulations are formulated in accordance with the provisions of relevant laws and regulations and in combination with the actual conditions of this province. Article 2 These regulations apply to the management of the production and sales of health care products within the administrative region of this province. Article 3 Health products as mentioned in these Regulations refer to products such as patches, ointments, liniments, sprays and other products that act directly or indirectly on the surface of human skin, are not intended to prevent and treat diseases, and have daily health care and recovery functions. . However, there are exceptions to laws and regulations that provide otherwise for drugs, health foods, medical devices, special-purpose cosmetics, disinfection products, sports equipment, etc. Article 4 The health administrative department of the Provincial People's Government is responsible for the health supervision and management of health care products in the province and the approval of health licenses for health care products.
The health administrative departments of municipal and state people’s governments, regional administrative offices and county-level people’s governments are responsible for the health supervision and management of health care products within their respective administrative regions.
Other relevant departments of the people's governments at or above the county level are responsible for the management of health care products in accordance with their respective responsibilities. Article 5: Encourage and support health product manufacturers to research and develop products, promote corporate innovation, improve product quality, and actively promote the certification of health product production quality management standards. Article 6: A health license system is implemented for health products. Article 7 To apply for a health license for health products, a health care product manufacturer shall meet the following conditions and apply for a production site review to the health administrative department of the local city, state people's government, or regional administrative office:
(1) Production The factory building should be built in a clean area and should be kept at a hygienic distance from toxic and harmful places;
(2) The ceilings, walls, and floors in the production workshop should be made of smooth building materials, with good daylighting or illumination, and have the ability to prevent and Facilities and measures to eliminate breeding conditions for rodents and other harmful insects;
(3) Health care products, raw materials, and finished products to be processed in the production workshop must not be cross-contaminated, and the finished products should not be exposed to unclean and toxic substances;
(4) There are places for handling, processing, packaging, and storage of health care product raw materials that are suitable for the variety and quantity of the products;
(5) Production facilities with suitable product production characteristics Equipment or facilities;
(6) Have reasonable equipment layout and process flow;
(7) Have a sound health management system.
After receiving the application, the health administrative departments of the municipal and prefecture people's governments and regional administrative offices shall go to the production site of the health care products manufacturer to conduct an examination within 15 days, and issue a review opinion to those who meet the conditions; to those who do not If the conditions are met, an unqualified opinion will be issued and the reasons will be explained in writing. Article 8 After the applicant has passed the inspection of the production site of the health care product manufacturer by the health administration department of the municipal, state people's government, or regional administrative office, the applicant may apply for a health care product hygiene license to the health administration department of the provincial people's government and provide the following information: < /p>
(1) Application form;
(2) Production site inspection qualification opinion issued by the health administration department of the municipal, state people’s government, or regional administrative office;
( 3) Product development report, naming basis, formulation basis and related information;
(4) Production enterprise and production site (workshop) layout plan;
(5) Product production process Flow chart;
(6) Current effective product quality standards;
(7) Functionality and safety report issued by the health care products review expert group;
(8) Product samples and recent product type inspection reports issued by institutions with inspection qualifications;
(9) Samples of product packaging, labels and instructions.
The functional and safety reports of health care products specified in Item 7 of the preceding paragraph shall be accompanied by the review opinions of the health care product review expert group.
Members of the health products review expert group are composed of experts in medicine, toxicology, pharmacology, nutrition, testing, medical devices, production technology, management, standard use and other related professions. The management measures for the health products review expert group shall be formulated separately by the Provincial People's Government. Article 9 The health administrative department of the Provincial People's Government shall, after receiving an application for a health license for health products, review the completeness of the application materials within 5 days and issue a notice of acceptance or rejection.
After accepting the application, the health administrative department of the Provincial People’s Government shall make a decision within 20 days.
For those that meet the licensing conditions, a health license for health products will be issued; for those that do not meet the licensing conditions, a decision will be made to deny the license and the reasons will be stated in writing. Article 10 When relevant inspection agencies that have obtained qualifications in accordance with the law are engaged in the inspection of health care products, they shall inspect whether the health care products meet product standards and safety in accordance with the technical specifications for inspection and evaluation of health care products.
Applicants can voluntarily choose a qualified inspection agency to inspect health products. Article 11: The inspection of health care products shall implement the responsibility system between the inspection agency and the inspector. The inspection report of health care products shall be stamped with the official seal of the inspection agency and shall have the signature or seal of the inspector. Inspection agencies and inspectors are responsible for the health product inspection reports issued, ensuring that the inspection data and conclusions issued are objective and fair, and false inspection reports are not allowed. Article 12 Health product approval authorities, review expert groups, and inspection agencies shall not disclose the business secrets of the applying enterprise. Article 13: The health license for health products is valid for 4 years. Health product manufacturers shall apply to the health administrative department of the provincial people's government for renewal of the health product license 30 days before the validity period of the health product license expires.
The health administrative department of the Provincial People's Government shall, based on the application of the health product manufacturing enterprise, make a decision on whether to approve the extension before the expiration of the health license for health products; if no decision is made within the time limit, the extension shall be deemed to be approved. If a health care product manufacturer does not apply for renewal before the expiration of the validity period, the original health care product hygiene license will become invalid upon expiration.