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National Food and Drug Administration Office [2012] No. 219 

Published on August 15, 2012 
 

 Each province、Autonomous Region、Food and Drug Administration (Drug Supervision Administration)，Xinjiang Production and Construction Corps Food and Drug Administration:

To further strengthen the safety supervision and management of drugs and medical equipment，Promoting the construction of the integrity system，Improve industry forbidden and exit mechanism，Supervise and warn manufacturers to fully perform quality and safety liability，According to the "Drug Management Law"、"Administrative License Law"、"Regulations on the Supervision and Management of Medical Devices"、"Regulations on the Disclosure of Government Information" and other related laws、Administrative Regulations，The National Food and Drug Administration has formulated "Drug Safety & LDQUO; Blacklist & RDQUO; Management Regulations (Trial)，Now issued，Please follow the execution。

National Food and Drug Administration
August 13, 2012

　
Drug safety & ldquo; blacklist & rdquo; management regulations (trial)

Article 1 In order to further strengthen the safety supervision and management of drugs and medical equipment，Promoting the construction of the integrity system，Improve industry forbidden and exit mechanism，Supervise manufacturers fully fulfill the responsibility for quality and safety，Enhance the supervision of the whole society，Alert illegal act，According to the "Drug Management Law"、"Administrative License Law"、"Regulations on the Supervision and Management of Medical Devices"、"Regulations on the Disclosure of Government Information" and other related laws、Administrative Regulations，Formulate this regulation。

Article 2 The food and drug supervision and management department of the provincial level shall establish drug safety & ldquo; blacklist & rdquo;，It will seriously violate the medicine、Medical Device Management Law、Regulations、The regulations are punished by administrative penalties and their direct responsible persons and stake betting appStake Sports Bettingother direct responsible persons (hereinafter referred to as responsible persons)，announced through the government website，Accept social supervision。

Article 3 The production and operators referred to in these regulations refer to the development of drugs and medical devices in the people's Republic of China、Production、Enterprises or other units operating and used。

Article 4 The National Food and Drug Administration is responsible for national drug safety & ldquo; blacklist & rdquo; management work，Provincial (district、City) Food and Drug Supervision and Administration Department is responsible for drug safety & ldquo; blacklist & rdquo; management work。

5 Drug safety & ldquo; Blacklist & rdquo;、Objectively and timely、The principle of fairness and justice will be announced。

Article 6 The food and drug supervision and management departments at or above the provincial level shall set up & ldquo; Drug safety & lsquo; blacklist & rsquo; column & rdquo;，and managed by a special person、Update in time。
The National Food and Drug Administration will investigate and operate the major administrative punishment cases investigated in accordance with these regulations、Responsible persons in & ldquo; Drug safety & lsquo; blacklist & rsquo; column & rdquo; announce。
Provincial provinces (district、City) The food and drug supervision and management department on its government website & ldquo; Drug safety & lsquo; blacklist & rsquo; column & rdquo; China announced the production and operators of drug safety & rdquo;、Responsible person，Submit to the State Food and Drug Administration。National Food and Drug Administration & ldquo; Drug safety & lsquo; blacklist & rsquo; column & rdquo; reprint the provinces (districts、City) Drug safety published by the food and drug supervision and management department of the Food and Drugs & LDQUO; Blacklist & RDQUO;。

Article 7 conforms to one of the following situations、Seriously illegal production and operators who have been punished by administrative punishment，It should be included in drug safety & ldquo; blacklist & rdquo ;:
(1) Production and selling fake drugs、Elementary drugs were revoked for drug approval documents or were revoked "Pharmaceutical Production License"、"Drug Business License" or "Medical Institution Preparation License";
(II) Registered certificate of medical device products to produce medical equipment，or the production does not meet national standards、Industry standard medical equipment is serious，or other production、Sales do not meet legal requirements for medical devices caused serious consequences，Registration certificate of medical device product products was revoked、"Medical Device Manufacturers License"、"Medical Device Business Business License";
(3) conceal the relevant situation during the application of the relevant administrative license、Provide false materials;
stake sports betting appstake betting app(4) Provide false certificates、File data samples or other deception、Bringing and other unfair means，Get relevant administrative license、Approval document or other qualifications;
(5) During the investigation of administrative punishment cases，Forge or deliberately destroy the scene，Transfer、Hidden、Forge or destroy relevant evidence，and refusal、Escape supervision and inspection or refuse to provide relevant situations and information，Expenses and seal seizure items;
(6) Because of medicine、illegal criminal behavior of medical device is punished;
(7) Others due to violations of legal conditions、Require production and sales medicine、Medical Device，caused by major quality and safety incidents，or with subjective intentional intention、bad plot、Drugs that are harmful、illegal behavior of medical equipment。
The plot of production and sales of fake drugs and production and sales is serious、Drug production is not allowed to be engaged in it within ten years、Responsible personnel for business activities，It should also be included in drug safety & ldquo; blacklist & rdquo;。

Article 8 of the announcement of drug safety & ldquo; blacklist & rdquo; time，For production and operators with one of the following situations，The deadline for prohibiting them from engaging in related activities shall be announced in accordance with the decision of administrative penalties:
(1) Production and operator of Article 7 (1) (3) of these regulations，Food and Drug Supervision and Administration Department shall not accept or give administrative permits for the administrative license application proposed，Production operators shall not apply for the administrative license again within one year，But in accordance with Article 70 of the Implementation Regulations of the Drug Management Law，It does not accept its application within three years;
(2) Production and operators of Article 7 (1) (4) of these provisions，Food and Drug Supervision and Administration Department in addition to revoking or revoking its license、Approval document or other qualifications，Production operators shall not apply for the administrative license again within three years，But in accordance with Article 83 of the Drug Management Law and Article 75 of the Regulations on the Management of Anesthesias and Psychiatric Drugs，It does not accept its application within five years。
Responsible persons who meet the situation of Article 7 of these regulations，Drug production and operators may not hire them to engage in drug production、Business activities。

Article 9: Incorporate drug safety & ldquo; blacklist & rdquo;，National Food and Drug Administration or provincial (district、City) The food and drug supervision and management department shall be within 15 working days after the administrative penalty My stake betting appdecision will take effect，Stake Sports BettingAnnounced on its government website。The National Food and Drug Administration shall receive the province (district、City) Drug safety reported by the food and drug supervision and management department & ldquo; blacklist & rdquo; within the last five working days，Reprinted on its government website。

Article 10 The announcement includes the name of illegal production operators、Business address、The name of the person in charge of the legal representative or the person in charge and the person in charge of the responsible person stipulated in Article 7 of these regulations、Job、ID number (hidden part number)、The cause of violations、Administrative penalty decision、Any information about the start and end date。

Article 11 in & ldquo; Drug safety & lsquo; blacklist & rsquo; column & rdquo; China announced illegal production and operators、Details of responsible persons，It should be consistent with the duration of the behavioral restriction measures。Law、The administrative regulations have not stipulated the behavioral restriction measures，The announcement period is two years。Calculated from the date of making administrative punishment decisions。
Announced the expiry of the period，& ldquo; Drug safety & lsquo; Blacklist & rsquo; column & rdquo; transfer to & ldquo; Drug safety & lsquo; blacklist & rsquo; database & rdquo;.，For the society for query。

Article 12 The food and drug supervision and management department is handling drugs、When the medical device -related administrative license items，Should be compared with & ldquo; Drug safety & lsquo; blacklist & rsquo; column & rdquo;，No license to the situation of Article 8 of these regulations。
Food and Drug Supervision and Administration Department found in the supervision and inspection that it violates Article 8 of these regulations，It should be corrected in time in accordance with the law。

Article 13 of & ldquo; Drug safety & lsquo; blacklist & rsquo; column & rdquo; illegal production operator，Food and Drug Supervision and Administration Department shall record it in the supervision file，and take increased inspection and draw frequency、Order measures and other measures such as regular reporting quality management，Implement key supervision。

Article 14 Food and Drug Supervision and Administration, in addition to publishing drug safety & ldquo; blacklist & rdquo;，It should also be in accordance with the requirements of the "Regulations on the Disclosure of Government Information" and the "Special Regulations of the State Council on Strengthening the Safety Supervision and Management of Food and other products"，Establish a record of illegal behavior records of production and operators，Record and announce the situation of all illegal acts，Promote the construction of a social integrity system。

Article 15 Food and Drug Supervisor violates these regulations，Abuse of power、徇 Private fraud、Attention，The main person in charge of the supervisory organs or appointment and removal stake betting appagencies、Direct responsible persons and stake betting appStake Sports Bettingother direct responsible persons give punishment。

Article 16 Encourage social organizations or individuals to supervise drug safety & ldquo; blacklist & rdquo;，Discovering illegal acts，I have the right to report to the food and drug supervision and management department。

Article 17 of the province (district、City) Food and Drug Supervision and Management Department may be in accordance with this regulation，Formation of drug safety & ldquo; blacklist & rdquo; management regulations for implementation rules。

Article 18 This provision shall be implemented from October 1, 2012。