First article for further strengthened drug and medical devices security supervision management, advance integrity system construction, perfect industry ban into and exit mechanism, urged production operators full perform quality security responsibility, enhanced society supervision Heli, deter violations, according to drug management method, and administrative license method, and medical devices supervision management regulations, and Government information public regulations and other related legal, and administrative regulations, developed this provides.
II food and drug supervision and administration departments at or above the provincial level shall, in accordance with the provisions of the call for the establishment of drug safety “blacklist” will change due to serious violations of the laws and regulations on management of pharmaceuticals, medical devices producers, regulations are administrative punishment and its charge directly responsible and other persons directly responsible (hereinafter persons) for information, through the Government Web site announced, subject to public supervision.
Production operator is referred to in the provisions of article People’s Republic of China territory of pharmaceuticals and medical equipment development, production, marketing and use of enterprise or any other entity.
Fourth national in charge of the national food and Drug Administration drug safety “blacklist” management of the provinces (regions and municipalities), food and drug supervision and management is responsible for drug safety in their respective jurisdictions “blacklist” management.
Article fifth drug safety “blacklist” shall, in accordance with the law in an open, objective, timely, fair and impartial principles to the public.
Sixth food and drug supervision and administration departments at or above the provincial level should be conspicuous in its Government Affairs home page “drug safety ‘ blacklist ‘ column”, and by the personnel management and timely updates.
National food and drug supervision and administration in accordance with the provisions of its deal with administrative punishment cases that production operator, responsible people involved in “drug safety ‘ blacklist ‘ column” to the public.
Provinces (regions and municipalities), food and Drug Administration on its Government website “drug safety ‘ blacklist ‘ column” published within their respective administrative areas into drug safety “blacklist” production operator, responsible people, and report to the State food and drug administration. The State food and drug administration “drug safety ‘ blacklist ‘ column” reprint provincial (district, municipal), released by the food and Drug Administration drug safety “blacklist”.
Article meets any of the following circumstances, subject to administrative punishment of serious illegal producers and traders should be incorporated into the drug safety “blacklist”:
(A) the production and marketing of counterfeit and substandard drugs was revoked by withdrawal of drug approval documents or the drug production licenses, the pharmaceutical business license or pharmaceutical preparation certificate for medical institution;
(B) the registration certificate manufacturing medical devices without a medical device products, production does not meet national standards, industry standards or in serious cases of medical devices, production, sales or other dire consequences of a medical device does not meet the statutory requirements, and being denied medical treatment apparatus product registered certificate, the medical device manufacturing enterprise license, the medical device distributing Enterprise license;
(C) in applying for administrative licensing process to hide the facts or providing false information;
(D) providing false certificates and documentation, samples or other fraud, bribery or other improper means, obtain the relevant approvals, approval certificate or other qualification;
(E) the administrative punishment cases investigated during forging or intentionally destroyed, transfer, concealment, falsification or destruction of relevant evidence, as well as reject, evade supervision and examination or refuses to provide information and reference materials, arbitrarily drawn attachment of seized items;
(Vi) due to drugs, medical devices of criminal acts subject to criminal punishment;
(VII) other violations of statutory conditions, require the production and marketing of drugs, medical devices, resulting in quality of major security events, or with intent, aggravated violations, harmful drugs, medical devices.
Production and sales of counterfeit medicines and the production and sale of substandard drugs in serious cases, punishment ten years engaged in drug production and distribution activities of persons should also be included in the drug safety “blacklist”.
Eighth article announced drug safety “blacklist”, the producers of one of the following circumstances shall be announced in accordance with the decision on administrative penalty which engage in activities related to the term:
(A) has this provides seventh article first paragraph subsection (three) items case of production operators, food drug supervision management sector on its proposed of administrative license applications not accepted or not administrative license, production operators in a years within shall not again applications the administrative license, but according to drug management method implementation regulations 70th article made administrative punishment decided of, three years within not accepted its applications;
(Ii) has this provides seventh article first paragraph subsection (four) items case of production operators, food drug supervision management sector except revoked or revoked its license, and approved proved file or other qualification outside, production operators in three years within shall not again applications the administrative license, but according to drug management method 83rd article and anesthesia drug and spirit drug management regulations 75th article made administrative punishment decided of, five years within not accepted its applications.
Consistent with the second paragraph of this article seventh persons ten years shall not be employed to drugs producers and traders engaged in drug production and business activities.
Nineth on in accordance with the provisions of clause seventh of drug safety “blacklists”, State food and drug administration or provincial (district, municipal) food and drug supervision and management departments should be on the administrative punishment decision within 15 working days of the entry into force, its Chief posted on the site. State food and Drug Administration should be receiving provinces (regions and municipalities) reported by food and Drug Administration drug safety “blacklist” within five working days, in its Chief reproduced on the Web site.
Tenth disclosures include illegal production operator’s name, address, legal representative or responsible person as well as the provisions of the second paragraph of this article seventh person’s name, title, ID number (HID part number), illegal subject matter, the decision on administrative penalty, release dates and other information.
11th “drug safety ‘ blacklist ‘ column” announced in term of the illegal producers and traders, responsible people, and behavioral restrictions of the term should be taken instead of being consistent. Does not specify behaviour restrictions by laws, administrative regulations, released for a period of two years. Period from the date on which the decision on administrative penalty.
Release expires, “drug safety ‘ blacklist ‘ column” the information in the “drug safety ‘ blacklist ‘ database” for social inquiry.
12th food and drug supervision and management departments in handling administrative licensing matters related to drugs, medical devices, should be evaluated with “drug safety ‘ blacklist ‘ column” in the review of the information, the applicant has no permission listed in this article eighth.
Food and drug supervision and management in relation to the supervision and inspection were found in violation of the provisions of article eighth, shall promptly be corrected in accordance with law.
The 13th place of “drug safety ‘ blacklist ‘ column” announced by illegal producers and traders, the food and drug regulatory departments shall be entered into the archives, and to increase the frequency of inspections and sampling and demanding regular quality management measures such as implementation of the key regulatory.
14th food and Drug Administration drug safety released in addition to “blacklist”, it shall, in accordance with the regulations on disclosure of Government information and the State Council on strengthening the supervision and management of food and product safety requirements of the special provisions, establish production records of illegal system of managers, on condition of all arrests be recorded and published, promoting the construction of social credit system.
15th article in violation of the provisions of the food and drug administration personnel, abuse, malpractice, negligence, the appointment and removal of the supervisory organ or organs shall directly responsible for its directors, supervisors and other personnel directly responsible shall be given disciplinary action.
16th to encourage social organizations and individuals listed in the drug safety “blacklist” oversight of the units and individuals, and found an illegal act has the right to report to the food and drug administration.
Article 17th provinces (regions and municipalities), the food and drug supervision and management departments in accordance with this provision, in light of local conditions to develop drug safety “blacklist” implementing rules for the regulations.
18th article of the regulations shall come into force on October 1, 2012.
