Product quality supervision, industry and commerce and other relevant administrative departments in their respective areas of responsibility, responsible for the supervision and management of health supplies. Article VI of health supplies to implement product registration and category catalog management system.
Health products category directory by the provincial food and drug supervision and management departments regularly announced to the community. Article VII encourages health care products manufacturers to research and development of new health care products with high scientific and technological content, and actively apply for health care products production quality management standard certification. Article 8 Any organization or individual has the right to report and reflect the production and sale of health products in violation of the law. Chapter II Product Registration Article IX apply for registration of health products, the applicant shall submit to the provincial food and drug supervision and management department of the following information:
(a) product development reports, naming basis, the basis of the formula or construction principles and related information;
(b) product production process;
(c) product quality standards;
(d) product testing Report;
(E) product packaging, labeling and specification samples;
(F) the manufacturer's business license and qualifications. Article 10 The provincial food and drug supervision and management department shall receive the declaration of information within three days after the declaration of normality, completeness, legality of the review, and issue a notice of acceptance or inadmissibility. Article XI of the provincial food and drug supervision and management department accepts the application for registration, it should be within fifteen days of the production conditions of the manufacturer, the qualifications of employees, quality management organizations, equipment and management system for on-site verification, verification opinions, and take samples for testing. Article XII of the law through the measurement of certified inspection agencies engaged in health care products inspection, in accordance with the provincial food and drug supervision and management departments of the provisions of the technical specifications for the inspection and evaluation of health care products, health care products for safety, health care functionality and hygiene testing. Health care products testing organizations on the test results independently assume legal responsibility.
Applicants in accordance with the principle of voluntary selection of testing organizations. Article XIII of the inspection agency shall be based on the provincial food and drug supervision and management department issued a test notice to receive samples and test. Article XIV of health care products Review Committee is responsible for health care products of the formula, structure, production process, quality standards, health effects, safety and scientific technical review.
The evaluation committee consists of experts in medicine, pharmacy, medical devices, manufacturing processes, light, machine, electricity, magnetism and other related professions.
Review committee members should be objective and impartial in the performance of their duties, abide by professional ethics, and take responsibility for the proposed review. Article XV of the provincial food and drug supervision and management departments shall receive the test report within sixty days after the organization of the review committee meeting, and based on the assessment of the technical review decision. Article XVI of the provincial food and drug supervision and management department on-site verification meets the requirements, through the technical review of the registration application, shall be registered and issued to the production of health care products approval certificate. Article XVII of health supplies production approval certificate is valid for three years. The expiration of the validity of the need to extend, the manufacturer shall apply for re-registration three months before the expiration date. Late application, or re-registration application was not approved, the original production approval certificate shall be void.
Health care products production approval certificate shall not be altered, sold, rented, loaned, and shall not be transferred without authorization. Article XVIII of the certificate of approval for the production of health care products need to change the approved matters, the certificate of approval holder shall submit an application for change, the provincial food and drug supervision and management department shall accept the application from the date of twenty days, to make a decision on the review. Change the validity of the approval documents and the original certificate of approval is the same.
The provincial food and drug supervision and management department agreed to increase the functional items, change the auxiliary materials or production site applications, samples should also be tested. The time required for the test is not calculated in the review period.
Health care products, functional name, raw materials, production processes, methods of use and other factors that may affect product safety or health effects of the content shall not be changed. Chapter III production and operation of Article 19 of the health care products manufacturer shall have the following conditions:
(a) with professional and technical personnel to meet the requirements;
(b) with its production of health care products compatible with the production of equipment, premises and sanitation environment;
(c) with the production of health care products can be produced by the quality of the institution or personnel and testing equipment.