Shaanxi Provincial Food and Drug Administration Solicits Opinions on Implementation Rules for Credit Restoration of Drug Supervision and Administration

On September 29, in order to continue to deepen the reform of “delegating control and service”, further optimize the business environment, and promote the establishment of a social credit system, the Shaanxi Provincial Food and Drug Administration issued regulations on the implementation of the Shaanxi Provincial Drug Administration Credit Repair (Draft for Solicitation of Comments) 》Announcement for comments
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The original text is as follows: The Announcement on Soliciting Comments on the "Implementation Rules of Shaanxi Drug Supervision and Administration Credit Restoration (Draft for Comment)" is to continuously deepen the reform of "delegation, regulation and service", further optimize the business environment, and promote the establishment of a social credit system, according to the national market The General Administration of Supervision and Administration "Administrative Measures on the List of Seriously Illegal and Untrustworthy in Market Supervision and Administration", "Administrative Measures on Credit Restoration in Market Supervision and Administration", and "Measures for Sharing and Joint Disciplinary Measures on Drug Safety "Blacklist" of Shaanxi Province (Trial)", our bureau organized the drafting "Shaanxi Province Drug Administration Credit Repair Implementation Rules (Draft for Solicitation of Comments)" is now open to the public for comments
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Please provide comments and suggestions on relevant content, and feedback via email, letter, etc.
, and the subject of the email should indicate "Feedback on Credit Repair Implementation Rules"
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The deadline for comments is October 18, 2021
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Feedback channels are as follows: 1.
E-mail: sxjdccc@163.
com 2.
Mailing address: Supervision and Sampling Office of Shaanxi Provincial Drug Administration (No.
56, Gaoxin 6th Road, Xi'an, Postcode: 710065) 3.
Contact person and phone number: Wu Weidong 029 -62288081 209-62288070 (fax) Attachment: Shaanxi Province Drug Administration Credit Repair Implementation Rules (Draft for Solicitation of Comments) Article 1 [Basis for Purpose] To continuously deepen the reform of “decentralization, management and service”, innovate and implement inclusive and prudential supervision, and further optimize operations Business environment, establish a long-term mechanism to prevent and reduce the occurrence of untrustworthy behaviors, and promote the construction of a social credit system, in accordance with the State Administration for Market Provincial Drug Safety "Blacklist" Information Sharing and Joint Punishment Measures (for Trial Implementation)", in accordance with the actual situation of our province, formulate these rules
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Article 2 [Scope of Application] These rules apply to those who have been publicized and received administrative penalties by the drug regulatory authority, have been included in the list of severely illegal and untrustworthy drugs (including medical devices and cosmetics), have been included in the management of drug blacklists and have fulfilled their statutory obligations and Credit restoration of serious illegal and untrustworthy enterprises with less social harm
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Article 3 [Conceptual Limitation] The term “seriously illegal and untrustworthy enterprises” mentioned in these rules refers to those enterprises that have been registered within the administrative divisions of Shaanxi Province and have been subject to administrative penalties by the drug regulatory authority and violated the “Management Measures for the List of Seriously Illegal and Untrustworthy Market Supervision and Administration” and “ The relevant provisions of the Shaanxi Drug Safety "Blacklist" Information Sharing and Joint Punishment Measures (for Trial Implementation)" are publicly announced and included in the list of severely illegal and untrustworthy enterprises (including medical devices and cosmetics, the same below) production and operation enterprises
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The term "credit restoration" as mentioned in these rules means that the drug regulatory authority removes eligible parties from the drug safety "blacklist" information publicity system on the government website in accordance with the prescribed procedures in accordance with the prescribed procedures, and removes relevant management measures in accordance with the law, and promptly removes them in accordance with regulations.
Credit restoration information is shared with relevant departments
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Article 4 [Principles of Implementation] Credit restoration shall follow the principles of application restoration and inclusive and prudent supervision
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Article 5 [Division of Responsibilities] The Provincial Drug Administration is responsible for organizing and guiding the credit restoration of enterprises with serious violations of laws and untrustworthiness throughout the province
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In accordance with the principle of “whoever takes in, who repairs”, the drug regulatory authorities at all levels are responsible for the acceptance, inspection, verification, and restoration of applications for credit restoration of registered enterprises with serious violations of laws and untrustworthiness.

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Article 6 [Applicable Conditions] Enterprises applying credit restoration must meet the following conditions: Except for the administrative penalties stipulated in Article 14 Paragraph 3 of the "Regulations on the Disclosure of Administrative Punishment Information on Market Supervision and Administration", or receive only warnings, notifications, criticisms, and drugs In addition to relatively low fines such as less than 3 million (inclusive), medical devices, cosmetics, and less than 1 million (inclusive), and other administrative penalty information disclosure period has expired for one year, and the parties meet the following circumstances, they can apply for credit restoration: (1) Already Consciously perform the obligations stipulated in the administrative penalty decision; (2) Have taken the initiative to eliminate the harmful consequences and adverse effects; (3) Have not been punished by the drug regulatory authority again for the same type of illegal behavior; (4) Have not been on the drug safety "blacklist" "In
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Article 7 [Application Conditions] If a party has been included in the drug safety "blacklist" for one year and meets the following circumstances, he can apply for credit restoration in accordance with the provisions of these Measures: (1) Has consciously performed the obligations specified in the administrative penalty decision; (2) Has taken the initiative to eliminate the harmful consequences and adverse effects; (3) Has not received severe administrative penalties from the drug regulatory authority
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In accordance with the provisions of laws and administrative regulations, if the time limit for implementing corresponding management measures has not expired, no application for early removal is allowed
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Article 8 [Restoration Materials and Acceptance Time Limit] When applying for credit restoration, the parties concerned shall submit the following materials: (1) Credit restoration application; (2) Letter of commitment to keep promises; (3) Relevant materials for fulfilling statutory obligations and correcting illegal acts; ( 4) Other materials required by the provincial drug regulatory authority
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The party concerned shall submit an application to the drug supervision and administration department that made the administrative penalty
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The drug supervision and administration department shall make a decision on whether to accept the application within two working days from the date of receipt of the application
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If the application materials are complete and conform to the statutory form, it shall be accepted and the parties concerned shall be notified
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If it is not accepted, the party concerned shall be notified and the reasons shall be explained
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Article 9 [Repair Procedure] The restoration of enterprise credit shall be carried out in accordance with the following procedures
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(1) Enterprise application
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An enterprise that meets the requirements for credit restoration shall submit a written restoration application to the government affairs acceptance hall of the drug regulatory department that made the administrative penalty, stating the facts and reasons for the application for restoration
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(2) Acceptance and review
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After receiving the credit restoration application, the drug regulatory authority shall conduct a preliminary review of the application materials submitted by the enterprise within 5 working days, accept the application materials that meet the conditions, and issue an acceptance notice to the enterprise; The enterprise shall issue a notice of non-acceptance and explain the reasons at the same time
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(3) Check and verify
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The drug regulatory authority shall inspect and verify the materials applied by the enterprise within 10 working days from the date of acceptance, and make a preliminary review opinion
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(4) Approval of the decision
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After inspection and verification, if the drug regulatory authority makes a preliminary review opinion that meets the conditions for credit restoration, it shall issue a decision to approve restoration within 5 working days after the inspection and verification, and remove the enterprise within 5 working days from the date of making the decision.
List of companies that have seriously violated the law and dishonesty
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(5) Filing on file
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The drug regulatory authorities at all levels shall file the relevant materials of the enterprises implementing credit restoration in a file for future reference
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Article 10 [Cancel Restoration] If the parties deliberately conceal the truth or resort to falsification, and the circumstances are serious, the drug regulatory authority shall revoke the decision to approve credit restoration and restore the previous status
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The publicity period of the administrative penalty information of the drug supervision and administration department and the list of serious violations of untrustworthiness is recalculated
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Article 11 [Method of Notification] After the drug regulatory authority agrees to repair, it shall notify the parties in writing
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Article 12 [No restoration] If the laws, regulations, and the policy documents of the Party Central Committee and the State Council clearly stipulate that credit restoration is not possible, the drug regulatory authority shall not grant credit restoration
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Article 13 [Reconsideration Litigation] The parties concerned may apply for administrative reconsideration or file an administrative lawsuit in accordance with the law on the decision of the drug regulatory authority to restore credit
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Article 14 These rules shall come into force on the date of promulgation
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Attachments: 1.
Credit repair application rejection notice 2.
Credit repair application acceptance notice 3.
Credit repair verification approval form 4.
Credit repair approval decision letter 5.
Credit repair approval decision letter