Administrative measures for the health products in Jilin province
(May 24, 2011 6th meeting consideration of the people's Government of Jilin province on June 25, 2011, Jilin provincial people's Government promulgated as of August 1, 2011, No. 224) first in order to strengthen the management of health products, regulate health products production and sales activities to ensure health products health, product quality and safety, safeguard the legitimate rights and interests of consumers, in accordance with relevant laws and regulations, combined with the facts of the province, these measures are formulated.
Second this approach applies to the provincial administrative areas within the health products production and sales of the units and individuals, as well as related management activities.
Article health products mentioned in these measures refers to regulate body functions, the promotion of a health product, but unless otherwise provided.
Fourth people's Governments above the county level health Administrative Department is responsible for the supervision and administration of health products within the administrative area.
The other relevant departments of the people's Governments above the county level, according to their respective responsibilities, supervision and administration of health supplies.
Article fifth encourages and supports health products enterprises research and development of new products, promote innovation, improve product quality, and promoting standardized management of health products manufacturer. Article sixth health products the implementation of approval system and catalog management system.
Of the certificate of approval for health supplies in Jilin Province issued by the provincial health administration.
Without obtaining of the certificate of approval for health supplies in Jilin province units or individuals shall engage in production activities of the health products.
Health products catalog category determined by the provincial health Administrative Department, and announced to the public in a timely manner.
Seventh health products production enterprise should have the following health conditions:
(A) the production company built in a clean area, with hazardous sites to maintain compliance with the statutory requirement of space;
(B) the plants shall be firm, clean, room ceiling, wall surface bright and clean building materials, lighting or lighting are good, with facilities to prevent and eliminate rodent and mosquito-infested conditions and measures;
(C) has adapted to the type, quantity and product health products raw materials, processing, packaging, storage premises or place;
(D) workshop for feature production facilities, process specification meet hygiene requirements;
(E) workshop to be processed, the health products, raw materials and finished products shall not be cross contamination, avoid product exposure to dirt, toxic substances;
(Vi) other conditions stipulated by laws and regulations.
Eighth section of the certificate of approval for health supplies in Jilin province of units and individuals, must have the seventh health requirements stipulated by these measures, and submit the following materials to provincial health administrative departments:
(I) 3 copies of the application form;
(B) production basis, principles of formula, construction or manufacturing, production and quality standards;
(C) the product safety evaluation report of the raw materials and products;
(D) health function evaluation reports;
(E) product samples;
(Vi) product labelling and product usage manual approval sample;
(G) the site health permit issued by the provincial health administrative departments (copy);
(VIII) use population health effects, 50 cases report of survey results;
(IX) Administration for industry and Commerce of the Enterprise name pre-approval notice issued by the Department;
(J) the testing institution certificate copy. Nineth provincial health Administrative Department shall within 10 working days from the date of receipt of application materials end of the handle.
Eligible shall approve and issue the certificate of approval; does not meet the criteria of, not approving, giving reasons, and notify the applicant in writing.
Applicant has obtained the certificate of approval for health supplies in Jilin province after the need to change the scope, should be to the original approved and registered by the Administrative Department for industry and Commerce scope change procedures.
Article tenth of the Jilin provincial certificate of approval for health products is valid for 4 years.
11th health products should be in accordance with test.
Testing by the official testing institutions, applicants may voluntarily select qualified testing organizations to test health products.
Article 12th qualification testing organizations to engage in health products tests shall be in accordance with technical specifications for inspection and evaluation of health products and health products compliance with product standards and safety testing.
On the test results, testing organization shall issue a test report, the testing report issued by, testing organizations testing data and conclusions should be guaranteed the objectivity, impartiality and shall not issue a false inspection report. 13th the applicant disagrees with the test report can be within 5 working days of receipt of the inspection report redetect applications health products Review Committee.
Review the Commission shall, within 10 working days to select a testing organization detected.
14th provincial health administrative departments of health products Review Committee made up of experts, responsible for the efficacy of health products in the province, health standards and the safety review, issue a review report.
Health Assessment Committee members health, toxicology, nutrition, test, pharmacology, medical equipment, administration, experts in the standards and other related professionals.
15th health supplies and approval authorities, Review Committee, the inspection body shall not disclose to the applicant's trade secrets.
16th provincial certificate of approval for health products out of units and individuals, working in the administrative areas of this province, health supplies production or marketing activities, it should be to the provincial health administration departments.
17th health products production enterprises shall not be changed without provincial health products approved by the Administrative Department of health product names, materials, site, factory production process, production approval number, name, usage and other information which may affect or change the function of the safety and health, need to change, the original approval authority.
Article 18th health supplies packaging should indicate the production date and the period of validity, main ingredient, health benefits, the application object, methods of use and attention.
Article 19th health products manuals, small contents of the packaging, labelling must be truthful, legal, scientific and meet product quality requirement and quality control of State and local requirements shall not deceive or mislead the public.
Against claims in the labels and instructions are indications, indications or disease prevention, healing or medicinal effect. 20th health products production enterprises shall establish a health products safety management system and quality control system.
For untested or unqualified health care supplies, no factory for sale.
21st health products should be in the product packaging (labels, instructions, etc) with "health supplies in Jilin Province".
22nd health supplies production personnel shall obtain a health certificate.
23rd is forbidden to alter, resell, lease, lent of the Jilin provincial certificate of approval for health products.
24th when buying health products health products sellers should obtain a copy of the original of the certificate of approval for health supplies in Jilin province and with holder seal.
Health products sellers may not be sold without approval, no certificate, expiration and invalidation of health products.
25th health products seller shall establish the health products purchase check account, faithfully record the name of health products, specifications, quantity, batch number, date, supplier name, purchase date, and more.
Health products purchase checking account should be reliable and keep it retained for periods of not less than 2 years.
26th health supplies advertisement should be true and legal, content may not be related to disease prevention and treatment, nor exaggerate the role of health products.
Approval of the Administrative Department for industry and Commerce health products advertising, strengthen the monitoring of health products advertising, timely investigate advertising violations.
27th provincial health Administrative Department published on its Web site each quarter made list of the certificate of approval for health supplies in Jilin province, community information and supervision.
28th provincial health, industry and commerce, quality and technical supervision and other relevant administrative departments should periodically for health products conducting supervision and inspection, and publicize the inspection results. 29th above county level health, industry and commerce, quality and technical supervision and Administration Department shall establish a health products manufacturers, sellers health products safety credit files, records approval certification review and inspection results, the offences investigated and dealt with, and so on.
Has a poor record of producers and marketers, industry and commerce administration, quality and technical supervision and Administration Department shall timely inform the provincial health Administrative Department. 30th article of any organization or individual has the right to report health products production and sales violations, is entitled to inform the relevant authorities about health products safety information on health products safety supervision and administration of its observations and recommendations.
Those reports are true, the relevant administrative departments should be given appropriate incentives.
31st Jilin province, without the production of the certificate of approval for health products health products, health administrative departments at and above the county level shall be ordered to correct, and a fine of 1000 Yuan more than 5000 Yuan fine.
32nd breach of these rules, any of the following acts, by the provincial health administrative departments to recover of the certificate of approval for health supplies in Jilin province, and fined 1000 Yuan more than 5000 Yuan the following fines:
(A) fraud or other improper means to obtain the certificate of approval for health supplies in Jilin province;
(B) alter, resell, lease, lent of the Jilin provincial certificate of approval for health products;
(C) approval of the change by the provincial health administration product formula, production processes, quality standards, product name and specification.
Article 33rd health products production and sales and test reports issued by units and individuals, drug administration in violation of the law, the product quality law, the hygiene supervision over cosmetics Ordinance and other laws, rules and regulations, from health, food and drug administration, quality supervision management, relevant departments for industry and Commerce administrative penalty according to law.
34th article violates this article 17th, 18th, 19th, 24th, 25th article, health administrative departments at and above the county level shall be subject to warning, rectification; fails to make corrections, shall be ordered to stop selling, and fined 1000 Yuan more than 5000 Yuan fine.
35th in the supervision and administration of administrative law enforcement personnel shall abuse, negligence, malpractice, by their work unit or Department at a higher level penalties constitute a crime, criminal responsibility shall be investigated according to law.
Article 36th acts in violation of these rules, otherwise penalty provisions in relevant laws and regulations, from its provisions. 37th article of the rules take effect on August 1, 2011.