Interpretation of the Implementation Measures for Food and Drug Complaints in Guizhou Province

Source: Food and Drug Administration of Guizhou Province

In order to standardize the management of food and drug complaints and reports, promote the social co-governance of food and drug safety, increase the punishment of food and drug violations, and ensure public health and life safety, according to the State Food and Drug Administration's Measures for the Administration of Food and Drug Complaints and Reports (State Administration Order No. 21), the Food and Drug Administration of Guizhou Province has formulated the "Implementation Measures for the Reporting of Food and Drug Complaints in Guizhou Province" (hereinafter referred to as the "Implementation Measures"). The implementation measures were implemented on May 25, 2016. The relevant issues are now interpreted as follows:

What is the scope of adjustment of the 1. "implementation measures?

These Measures shall apply to the reporting and management of food and drug complaints, which mainly include:

(I) citizens, legal persons or other organizations to complain and report suspected illegal acts related to food safety in the production and operation of food (including food additives);

(II) citizens, legal persons or other organizations to complain and report suspected illegal acts related to product quality and safety in the development, production, operation and use of drugs, medical devices and cosmetics;

(III) the management of complaints and reports by food and drug supervision and administration departments at all levels, complaint reporting agencies, and complaint reporting undertaking departments.

What is the meaning of 2. food and drug complaints?

The Implementation Measures stipulate that food and drug complaints and reports refer to citizens, legal persons, or other organizations reporting to the food and drug supervision and administration departments at all levels that producers, operators and other entities are related to food safety in the production and operation of food (including food additives). Suspected violations of product quality and safety in the development, production, operation, and use of drugs, medical devices, and cosmetics.

How are the responsibilities of food and drug supervision and administration departments at all levels divided by the 3. "Implementation Measures?

The implementation measures emphasize that the food and drug supervision and administration departments at all levels should strengthen the guidance and coordination of the management of food and drug complaints and reports, implement the principles of unified leadership, territorial management, administration according to law, and social co governance, and stipulate the responsibilities of the provincial food and drug administration and the food and drug supervision and administration departments at all levels.

(I) Provincial Food and Drug Administration is responsible for formulating and supervising the implementation of food and drug complaint reporting management systems and policies in our province; investigating and handling food and drug complaints that have a significant impact on the province and releasing relevant information; notifying and reporting to the State Food and Drug Administration Report the management of food and drug complaints in the province; coordinate and guide the specific work of food and drug complaint reporting agencies at the same level.

(II) food and drug supervision and administration departments at all levels are responsible for formulating food and drug complaint reporting management systems and policies in their administrative regions in accordance with the Implementation Measures and supervising their implementation; investigating and handling food and drug complaints in their administrative regions and releasing relevant information; notifying and reporting to superiors Report on the management of food and drug complaints in this administrative region; coordinate and guide the specific work of food and drug complaint reporting agencies at the same level.

How are the responsibilities of food and drug complaint reporting agencies at all levels stipulated in the 4. Implementation Measures?

The "Implementation Measures" stipulate the responsibilities of the complaint reporting agencies of the Provincial Food and Drug Administration and the complaint reporting agencies of the food and drug regulatory authorities at all levels.

The complaint reporting agency of the food and drug regulatory department of (I) Province is responsible for accepting, transferring, transferring, tracking, supervising and reviewing the food and drug complaints directly received; transferring, transferring, tracking, supervising, reviewing and reporting the food and drug complaints transferred by the complaint reporting agency of the State Food and Drug Administration; Collect, summarize and analyze the food and drug complaint reporting information of the whole province, regularly publish the province's food and drug complaint reporting analysis report, and regularly report to the State Food and Drug Administration's complaint reporting agency as required; formulate the province's food and drug complaint reporting management procedures, standards and specifications, and conduct food and drug complaint reporting agencies at all levels Business guidance; undertake the publicity and training of the province's food and drug complaint reporting management.

Complaint reporting agencies of food and drug regulatory departments at all levels in the (II) are responsible for accepting, transferring, transferring, tracking, supervising and reviewing directly received food and drug complaints and reports; transferring, transferring, tracking, supervising, reviewing and reporting food and drug complaints and reports transferred by superiors; providing business guidance to subordinate food and drug complaint reporting agencies; Collect, summarize and analyze food and drug complaint reporting information in this administrative region, regularly report to the food and drug complaint reporting agency at the next higher level as required; undertake the publicity and training of food and drug complaint reporting in the administrative region.

What elements should be provided when 5. a complaint whistleblower to report a complaint?

The complaint whistleblower shall provide objective and true complaint reporting materials and evidence, explain the basic course of the matter, and provide detailed information such as the name and address of the subject of the complaint, and the specific acts suspected of breaking the law. Promote real-name complaints and reports. If the whistleblower is unwilling to provide his name, identity, contact information and other personal information or is unwilling to disclose the complaint and report behavior, it shall be respected.

How is the scope of acceptance of food and drug complaints and reports stipulated in the Implementation Measures?

The Implementation Measures provide for the scope of acceptance of complaints and reports in a positive and negative way. In line with Article 2 of the "Implementation Measures", it reflects that producers, operators and other entities are related to food safety in the production and operation of food (including food additives), and the development, production, operation, and use of drugs, medical devices, and cosmetics. Suspected violations of product quality and safety shall be accepted. If the complaint report has one of the following circumstances, it shall not be accepted and the whistleblower shall be notified in an appropriate manner:

(I) there is no specific and clear object of complaint and illegal act;

(II) the object of the complaint and the illegal act are not within the jurisdiction of the food and drug complaint reporting agency or management department;

The (III) does not fall within the scope of the regulatory duties of the food and drug supervision and administration department;

(IV) the complaint has been accepted and is still in the process of investigation and handling, the complaint whistleblower repeats the complaint and report on the same matter;

(V) the complaint and report has been handled according to law, and the complaint and report person repeats the complaint and report with the same fact or reason without new clues;

(VI) illegal act has exceeded the legal time limit for prosecution;

The (VII) shall be resolved through legal means such as litigation, arbitration, administrative reconsideration, or has entered the above-mentioned procedures;

(VIII) other circumstances that should not be accepted according to law.

The "Implementation Measures" also stipulate that complaints and reports contain both content that should be accepted and should not be accepted. If a distinction can be made, the content that should not be accepted will not be accepted.

What are the provisions of the 7. Implementation Measures on the time limit for acceptance?

After receiving the complaint report, the food and drug complaint reporting institution or the administrative department shall uniformly code it, and make a decision on whether to accept it within 5 days from the date of receipt. If the food and drug complaint reporting agency or the administrative department decides not to accept the complaint report or not to accept part of the content of the complaint report, it shall inform the complaint whistleblower of the decision and reasons for the inadmissibility in an appropriate manner within 15 days from the date of making the inadmissibility decision, except where the contact information of the complaint whistleblower is unknown. If the complaint is not informed in accordance with the above provisions, the complaint shall be accepted on the 5th day from the date of receipt by the food and drug complaint reporting institution or the administrative department.

What are the important complaints reported 8. the implementation measures?

The Implementation Measures stipulate that a complaint report is an important complaint report if it meets one of the following conditions:

(I) claims to have caused death, serious disability, multiple disability and other serious consequences;

(II) may cause serious food-borne or drug-borne safety hazards;

(III) may involve national interests or cause significant social impact;

(IV) may cause systemic and regional risks;

(V) food and drug complaint reporting agencies or other complaints that management departments consider important.

How does the 9. "Implementation Measures" stipulate the time limit for food and drug complaint reporting agencies to transfer complaints and reports?

After accepting general complaints and reports, food and drug complaint reporting institutions at all levels shall, in accordance with the principles of territorial management and the division of regulatory responsibilities, transfer them to the relevant departments for handling within 3 days from the date of acceptance; after accepting important complaints and reports, they shall be transferred to the food at the same level within 2 days. The drug supervision and administration department put forward handling opinions.

What are the provisions of the 10. "Implementation Measures" on the deadline for handling food and drug complaints?

The complaint reporting department shall, within 60 days from the date of acceptance of the complaint report, feed back the handling results to the complaint whistleblower; if the situation is complicated, the handling period may be appropriately extended with approval before the expiration of the 60-day time limit, and inform the complaint whistleblower that it is being handled. After the completion of the complaint, the whistleblower shall be informed of the results of the handling.

If the complaint report is postponed, the extension period shall generally not exceed 30 days. Where laws, administrative regulations and rules provide otherwise, such provisions shall prevail. The following time shall not be counted in the time limit for handling complaints and reports:

(I) determine the time required by the food and drug complaint reporting agency or management department under its jurisdiction;

(II) the time required for inspection and testing, identification, expert review or demonstration in the process of handling complaints by the complaint reporting department;

(III) the time required for other departments to assist in the investigation.

If it is necessary to continue to extend the processing time limit for particularly complex and difficult complaints and reports, it shall report in writing to the person in charge of the complaint reporting department for approval, and promptly inform the complaint reporting agency or management department of the extension and the food and drug complaint reporting agency or management department to which the complaint is transferred.

If the complaint whistleblower consults on the progress of the complaint handling process, the complaint handling department shall inform it in an appropriate way that it is being handled.

11. How does the Implementation Measures stipulate the tracking and supervision of food and drug complaint reporting agencies?

Food and drug complaint reporting institutions shall promptly track and understand the handling of transferred complaints and reports, and lower-level food and drug complaint reporting institutions or complaint reporting departments shall cooperate. If the complaint report has not been completed for more than 50 days from the date of acceptance, the food and drug complaint reporting agency may urge the complaint reporting department to handle it in a timely manner, except for the approved extension. If the complaint report is not completed in time after the expiration of the time limit for handling the complaint or fails to feed back the handling results to the complaint whistleblower, the food and drug complaint reporting agency may, depending on the circumstances, request the higher-level business department of the complaint reporting department for supervision.

12. What are the circumstances in the "Implementation Measures" that complaint reporting agencies can make suggestions for improvement to the complaint reporting department?

If a food and drug complaint reporting agency finds any of the following circumstances, it may put forward suggestions for improvement to the complaint reporting department:

The (I) fails to handle the complaint report within the prescribed time limit;

The (II) fails to feed back the handling results to the complaint whistleblower and the food and drug complaint reporting institution, or the feedback is improper.

What are the requirements for the construction and management of food and drug complaint reporting data centers in the Implementation Measures?

The Provincial Food and Drug Administration is responsible for building a provincial food and drug complaint reporting data center to achieve data exchange and sharing with the national food and drug complaint reporting data center. Food and drug supervision and administration departments at all levels are responsible for the construction of the food and drug complaint reporting data center. Food and drug complaint reporting institutions or administrative departments at all levels shall, through the complaint reporting information management system, report the complaints and reports of their administrative regions and the consultation, opinions and suggestions related to the management of complaints and reports to the provincial food and drug complaint reporting data center on a regular basis.

Food and drug supervision and administration departments at all levels shall make full use of the complaint reporting information management system to standardize the acceptance, transfer, tracking, coordination, summary, analysis, feedback and notification of food and drug complaint reporting institutions at all levels, strengthen the monitoring and control of complaint reporting information, timely early warning, and effectively prevent food and drug safety risks.

14. What are the special provisions of the Implementation Measures on the statistical analysis of information on complaint reporting agencies?

Food and drug complaint reporting agencies at all levels shall regularly summarize and analyze information such as complaints and reports in their administrative regions and consultations, opinions and suggestions related to the management of complaints and reports, find weak links, put forward regulatory measures and suggestions, and report to the food and drug supervision and administration at the same level Departments and food and drug complaint reporting agencies at the next higher level.

The complaint reporting agencies of the food and drug supervision and administration departments at all levels shall submit the tendentious, risky, and group food and drug safety issues raised by the complaint whistleblower to the provincial food and drug administration complaint reporting agency in real time, At the same time, copy to the person in charge of the food and drug supervision and administration department at the same level and inspection and other relevant departments for reference.

15. What are the requirements of the Measures on the information notification of complaint reporting agencies at the provincial and municipal (state) levels?

The "Implementation Measures" stipulate that the complaint reporting agency of the Provincial Food and Drug Administration and the complaint reporting agency of the municipal (prefecture) food and drug supervision and administration department shall regularly report the following information:

Statistical analysis results of (I) complaints and reports;

(II) the overall situation of handling complaints and reports by the departments that handle complaints and reports;

(III) the work of food and drug complaint reporting institutions at the next level;

(IV) other information that should be reported.

16. What are the provisions of the "Implementation Measures" on the work guidelines for the staff of complaint reporting agencies and undertaking departments?

Food and drug complaint reporting agencies at all levels and complaint reporting undertaking departments shall protect the legitimate rights and interests of the complaint whistleblowers and the objects of complaint reporting in accordance with the law, and abide by the following working standards:

If the (I) has a direct interest in the content of the complaint or the whistleblower or the object of the complaint, it shall withdraw;

(II) the registration, acceptance, handling, and tracking of complaints and reports, they shall be kept strictly confidential in accordance with relevant laws and regulations, establish and improve the work responsibility system, and shall not privately extract, copy, seize, or destroy complaint and report materials;

(III) It is strictly forbidden to disclose the relevant information of the complaint whistleblower; It is strictly forbidden to disclose the information of the complaint whistleblower to the object of complaint and the personnel unrelated to the investigation and handling of the complaint and report case, and it is not allowed to discuss the situation of the complaint and report case with the irrelevant personnel;

(IV) complaint reporting process shall not disclose the information of the object of complaint reporting.

17. How does the "Implementation Measures" stipulate the legal responsibilities of the staff of food and drug complaint reporting agencies and undertaking departments?

If the staff of food and drug complaint reporting institutions and complaint reporting departments at all levels abuse their power, neglect their duties, engage in malpractices for personal gain in the management of complaints and reports, or cause serious consequences in violation of the provisions of these measures, the relevant personnel shall be investigated for responsibility according to law; if a crime is constituted, it shall be transferred to the judicial organ for handling.

18. What are the special provisions of the Implementation Measures for the protection of rights by complaint whistleblowers in accordance with the law?

The complaint whistleblower shall report the situation and the materials provided shall be objective and true, and shall not falsely accuse others; the complaint whistleblower shall exercise the right to complain and report in accordance with the law, and shall not use violence, coercion or other illegal means to interfere with the normal work of food and drug complaint reporting agencies and complaint reporting agencies. order. Violations of public security management laws and regulations shall be handed over to the public security organs for handling; if a crime is constituted, it shall be transferred to the judicial organs for handling.

19. What is the food and drug complaint reporting agency or management department stipulated in the Implementation Measures?

The food and drug complaint reporting agency or management department mentioned in the Implementation Measures refers to the agency or department responsible for the acceptance, transfer, tracking, coordination, summary, analysis, feedback, and notification of food and drug complaints, including:

An independent food and drug complaint reporting institution set up by the (I) food and drug administration;

(II) there is no independent food and drug complaint reporting agency, the food and drug supervision and administration department designated by the internal institutions or other institutions.

20. What is the complaint reporting department stipulated in the Implementation Measures?

The complaint reporting department referred to in the "Implementation Measures" refers to the food and drug supervision and administration department that is specifically responsible for the investigation of complaints and reports and making final decisions.