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Administrative Measures For The Health Products In Jilin Province

Original Language Title: 吉林省保健用品管理办法

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Health supplies management in Glin Province

(The 6th ordinary meeting of the People's Government of Chilin Province, 24 May 2011, was considered through the publication of Decree No. 224 of 25 June 2011 of the People's Government Order No. 224 of 25 June 2011, effective 1 August 2011)

Article 1, in order to strengthen the management of health supplies, regulate the production and sale of health supplies, ensure the health function, quality of products and safety of health supplies, preserve the legitimate rights and interests of consumers, and develop this approach in the light of the relevant laws, regulations and regulations.

Article 2, this approach applies to units and individuals involved in the production and marketing of health supplies within the province's administration and to related management activities.

Article III refers to health supplies as a product that regulates human functions and enhances health, except as otherwise provided by the State.

Article 4

Other relevant sectors of the people's government at the district level are governed by their respective responsibilities.

Article 5 encourages and supports the development of new products for the production of health supplies, the promotion of enterprise innovation, the quality of products and the promotion of the regulatory management of the production of health supplies.

Article 6. The Glin Provincial Health Supply Approval Certificate was issued by the Provincial Health Administration.

There are no units and individuals that have obtained the certificates of ratification of health supplies in the provinces of Glinin and do not engage in the production of health-care supplies.

The types of health supplies are determined by the provincial health administration and are made available to society in a timely manner.

Article 7.

(i) The construction of enterprises in clean areas and the maintenance of intervals with toxic hazardous sites consistent with statutory health requirements;

(ii) The plant should be solid, clean, use of photocetic construction materials on the ground of the vehicle's innerboard, wall wall walls, sampling or lighting, facilities and measures that prevent and eliminate the conditions of rat and mosquito pyrotechnics;

(iii) The existence of plant or premises that are adapted to product varieties, quantity and quantity;

(iv) The production facilities that are suitable for product characteristics for the production of vehicles, which are consistent with health requirements;

(v) Health supplies, raw materials, products and goods that are pending in the production of the vehicle shall not be subject to cross-cutting pollution, avoiding exposure to undesirable and toxic goods;

(vi) Other conditions under the law, regulations.

Article 8 units and individuals who apply for the approval of health supplies in the provinces of Glinin must have the health conditions set out in Article 7 of this scheme and submit the following materials to the provincial health administration:

(i) Three applications;

(ii) Product production patterns, formulations, or manufactures, production processes and quality standards;

(iii) Safety evaluation of raw materials and products;

(iv) Evaluation of product health functions;

(v) Product samples;

(vi) Goods labelling and product use statements to be delivered;

(vii) Place health permits granted by the provincial health administration (reprinted);

(viii) The effectiveness of the health function of the population, with 50 sample results reported;

(ix) Notification of pre-approval of enterprise names by the business administration sector;

(x) Accreditation of institutions.

Article 9. The provincial health administration should be completed within 10 working days from the date of receipt of the request. In accordance with conditions, they are approved and issued for the approval of the certificate; they are not subject to conditions, are not approved, justifying the reasons and notify the applicant in writing.

The applicant will need to change the scope of the operation after obtaining a certificate for the approval of health supplies in Glini province, and shall also conduct a change in the scope of the operation by the registered business administration.

Article 10 Approval of health supplies in the provinces of Glin is valid for four years.

Article 11. Health supplies should be tested by law.

The testing process is assumed by the statutory inspection body and the applicant can voluntarily choose a qualitative test agency to test health supplies.

Article 12. When the competent testing body is carried out under the law for health-care supplies testing and evaluation of technical norms, health supplies should be tested in conformity with product standards and safety.

As to the results of the testing, the detection body should have a test report, and the testing body should ensure that the data and conclusions are objective, impartial and that there are no false monitoring reports.

Article 13. The applicant contests the testing report and may submit a request for re-examination to the Committee for the Evaluation of Health Goods within five working days from the date of receipt of the testing report. The Evaluation Committee should re-elected a testing body within 10 working days.

Article 14. The provincial health administration has established a health supplies evaluation committee consisting of the experts concerned, which is responsible for the effectiveness, health standards and safety evaluation of health supplies in the province and for evaluation reports.

The members of the Committee for the Evaluation of Health Goods are composed of experts of the relevant professions, such as medical, toxicology, nutrition, testing, medicine, medical equipment, administration, standard use.

Article 15. The health-care supplies approval bodies, the evaluation committee, the testing body shall not disclose the commercial secrets of the applicant.

Article 16 provides units and individuals that have obtained certificates of approval for health supplies outside the province, who are involved in the production or sale of health supplies within the province's administration and should be backed by the provincial health administration.

Article 17

Article 18

Article 19 Use of statements of descriptions, minor packagings, labels must be authentic, legitimate, scientific, consistent with product quality requirements and national and local quality management provisions, without deceiving and misleading the public.

It is prohibited to declare functional responsibilities, adaptation or disease prevention, treatment functions or pharmacies in labels, notes.

Article 20 The sale of untested or unqualified health supplies is not possible.

Article 21 Health supplies should be assembled outside of products (including labelling, use of notes, etc.) with the words “Highforests for health”.

Health supplies producers should obtain health certificates.

Article 23 prohibits the conversion, sale, rental and loan of a certificate of approval for health supplies in Glin.

In the case of the purchase of health-care supplies by health-care providers, copies of the original certificates of approval for health supplies in the provinces of Glinin should be sought and the seals of the holders.

Health supplies are not sold without approval, without qualification, expire and invalid health supplies.

Article 25 Health supplies solders should establish health-care supplies to check receipts, such as record-keeping of the name, specifications, quantity, production kits, insurance periods, name of the supplier, entry date.

Health supplies should be checked for receipts, which should be real and reliable, properly maintained, and the duration of the maintenance is not less than two years.

Article 26 advertisements of health supplies should be authentic and should not involve the prevention and treatment functions of diseases or the role of health supplies.

The business administration approves the advertisement of health supplies, strengthens the regulation of advertisements in health-care supplies, and conducts advertisements in a timely manner.

Article 27 of the provincial health administration publishes, on its website, a list of certificates for the approval of health supplies in the provinces of Glinin to facilitate social week awareness and oversight.

The relevant administrations, such as provincial health, business and quality technical supervision, should conduct regular inspections of health supplies and publicize the findings.

More than twenty-ninth executive departments, such as health, business and quality technical supervision at the district level, should establish health-care supplies producers, safe credit files for the sale of health-care supplies, record the approval of the certificate for the issuance of review and monitoring findings and the investigation of violations. For producers and sales with poor records, the management of business administration, quality technology supervision should be informed by the provincial health administration in a timely manner.

Any organization and individuals have the right to report on the production and sale of health-care supplies and have the right to inform the relevant sectors of the security information on health supplies and to make observations and recommendations on the management of the safety monitoring of health supplies. The executive branch should be given appropriate incentives for reporting violators.

Article 31 does not obtain a certificate of approval of health supplies in the provinces of Glin, which is being converted by an order of responsibility for the health administration at the district level and is fined by over 5,000 dollars.

In violation of this approach, one of the following acts has been recovered by the Provincial Health Administration of the Certificate of Approval of Health Goods in the Province of Chilin and fined by over 5,000 dollars:

(i) Removal or other unjustifiable means of obtaining a certificate of approval of health supplies in the provinces of Glinin;

(ii) Restructuring, selling, renting and borrowing from the Certificate of Approval of Health Goods in Glinland;

(iii) The unauthorized change in the distribution of products approved by the Provincial Health Administration, production processes, quality standards, product name and use of notes.

Article 33 units and individuals involved in the production and sale of health supplies and the identification of reports violate the laws, regulations and regulations, such as the Medicine Management Act, the Product Quality Act, the sensitisation of sanswers, which are punishable by law by the relevant authorities, such as health, food medicine surveillance management, quality technical supervision management, and business administration.

Article 33, article 17, article 18, article 19, article 24, article 25, provides that the health administration at the district level is warned by law to correct the deadline; that the sale is terminated by an end to the sale by fine of more than 5,000 dollars.

Article XV Abuse by administrative law enforcement officials in the supervision of management, incentivism, in favour of private fraud, is administratively disposed of by their units or at the superior authorities; and constitutes criminal liability under the law.

Article XVI provides for violations of the provisions of this approach, with the relevant legal, legislative and other penalties.

Article 37