Circular of the China Food and Drug Administration on Seeking Public Comments on the Rules of Evidence in Food and Drug Supervision and Law Enforcement Activities (Draft for Comment)
Circular of the China Food and Drug Administration on Seeking Public Comments on the Rules of Evidence in Food and Drug Supervision and Law Enforcement Activities (Draft for Comment)
Circular of the China Food and Drug Administration on Seeking Public Comments on the Rules of Evidence in Food and Drug Supervision and Law Enforcement Activities (Draft for Comment)
December 7, 2017
In order to strengthen the law enforcement guidance for the food and drug supervision system and enhance the whole system's awareness of law enforcement evidence, the China Food and Drug Administration has drafted the Rules of Evidence in Food and Drug Supervision and Law Enforcement Activities (Draft for Comment), for which public comments are hereby sought. The public may give opinions via the following ways before January 6, 2018:
1. Log onto the website "China Legislative Information Network" at: http://www.chinalaw.gov.cn, and open the "Legislative Opinion Solicitation" column on the homepage to give your opinions.
2. Send your opinions by letter to the Legislative Department of the China Food and Drug Administration at Building 2, Courtyard No.26, West Street, Xuanwumen, Xicheng District, Beijing (Zip Code: 100053) and mark "Feedback Opinions on the Rules of Evidence in Food and Drug Supervision and Law Enforcement Activities" on the envelope.
3. Send your opinion by fax to: 010-88330782
Rules of Evidence in Food and Drug Supervision and Law Enforcement Activities (Draft for Comment)
Chapter I General Provisions
Article 1 [Purpose and Basis] In order to strengthen the food and drug supervision and administration, regulate the application of law enforcement evidence, and protect the legitimate rights and interests of citizens, legal persons or other organizations, the Rules of Evidence in Food and Drug Supervision and Law Enforcement Activities (Draft for Comment) (hereinafter referred to as the "Rules") are formulated in accordance with the Administrative Licensing Law of the People's Republic of China, the Administrative Coercion Law of the People's Republic of China, the Law of the People's Republic of China on Administrative Penalties, the Food Safety Law of the People's Republic of China, the Drug Administration Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices, the Regulations on the Hygienic Supervision of Cosmetics and other laws and regulations and the relevant provisions, and in combination with the actual situation of food and drug supervision.
Article 2 [Scope of Application] Food and drug administrations shall comply with the Rules when collecting, examining and applying evidence in its supervision and administration.
Article 3 [Definition of Evidence] For the purpose of the Rules, evidence refers to materials used to prove specific facts relating to food and drug supervision and law enforcement and in line with legal formal requirements.
Article 4 [Principle for Fact Finding] Food and drug administrations shall take conclusive and adequate evidence as the basis for juristic fact finding when making specific administrative decisions according to legal procedures, standards and requirements.
Article 5 [Principle for Evidence Collection] Food and drug administrations and their law enforcement officials shall comprehensively, objectively, fairly and timely investigate and collect evidentiary materials related to specific administrative matters or cases.
Law enforcement officials shall carry out necessary examination and verification of the evidence submitted by the parties.
Article 6 [Principle for Evidence Examination] Food and drug administrations shall establish a sound system for the examination of evidence in administrative supervision and law enforcement activities to ensure the legitimacy, authenticity, relevancy and adequacy.
Article 7 [Principle for Evidence Use and Confidentiality] Food and drug administrations and their law enforcement officials may not use legally obtained evidence for any purpose other than administrative supervision and administration.
Evidence that relates to state secrets, business secrets or personal privacy or should be kept confidential as required by laws shall not be disclosed to the public. Where laws or regulations have separate provisions, such provisions shall prevail.
Article 8 [Principle for Evidence Disclosure] Where the relevant entities or individuals apply to food and drug administrations for disclosure of the relevant information on administrative supervision and law enforcement activities, disclosure shall be made according to the administrative provisions on the disclosure of government information.
Chapter II Evidence Collection
Section 1 Basic Requirements
Article 9 [Category of Evidence] Evidence in food and drug supervision and law enforcement activities mainly include: documentary evidence, physical evidence, audio-visual materials, electronic data, testimony of witnesses, statements of the parties, inspection reports, identification opinions, authentication opinions and on-site inspection records, etc.
Article 10 [Basic Requirements for Evidence Collection] Law enforcement officials of food and drug administrations shall abide by the following provisions when collecting evidence:
1. they shall have the corresponding law enforcement qualification when collecting evidence, and shall voluntarily show their law enforcement certificates.
2. they shall inform the administrative counterpart of the right to apply for withdrawal of law enforcement officials; and shall voluntarily withdraw if they have a direct stake in the parties or the investigation subject.
3. they shall notify the administrative counterpart to legally offer cooperation in the investigation and that if the administrative counterpart fails to truthfully provide evidence or testimony, or gives false testimony, or forges, conceals or destroys evidence, or obstructs the investigation, it shall bear the legal liability.
4. they shall not collect evidence in violation of statutory procedures, or by inducement, fraud, coercion, violence or other illegal means, or by infringing the legitimate rights and interests of others or violating legal prohibitive provisions.
Article 11 [Means of Evidence Collection] Food and drug administrations shall collect evidence by the following means:
1. entering food and drug production or operation places or other related places for on-site inspection;
2. investigating and inquiring about the parties or other relevant personnel, and listening to the statements and defenses of the parties;
3. checking food, drugs and the related products, raw materials, ingredients, additives, etc., and conducting sampling inspection, testing, quarantine or identification according to the relevant provisions;
4. sealing up or detaining food, drugs and the related products, tools, places and so on that may be suspected of being illegal or have hidden security risks;
5. first registering the evidence for preservation, or copying, duplicating, photographing, or making picture recordings of the evidence or taking other protective measures against the evidence in accordance with the law if there is a likelihood that the evidence may be lost or destroyed, or difficult to obtain at a later date;
6. collecting the relevant materials through official documents of state organs and other functional departments;
7. obtaining evidence from administrative licensing, product registration, system certification, and daily supervision and inspection records and other relevant materials;
8. collecting evidence by consulting the computer system or other electronic information recording equipment;
9. collecting evidence by accepting complaints, reporting and so on; and
10. collecting evidence by other means.
Section 2 Documentary Evidence
Article 12 [General Forms of Documentary Evidence] Documentary evidence mainly includes:
1. application, acceptance, evaluation and approval and other related materials, approval and certification documents, authentication certificates, archiving credentials and identification materials formed during the process of related administrative licensing, product registration and management certification;
2. the related contracts, bills, lists, books, records, documents, pictures, professional technical information, etc.;
3. announcements, notifications, circulars, official replies, investigation replies and other official documents issued by state organs and other functional departments according to their legal functions and powers, effective written judgments of people's courts or effective written arbitrations of arbitration agencies;
4. documents on administrative penalty, administrative adjudication, administrative reconsideration and other decisions made by food and drug administrations or other functional departments in accordance with the law, and inspection records and other written materials formed in the process of their supervision and law enforcement activities; and
5. other written materials that can prove specific facts.
Article 13 [General Requirements for Collecting Documentary Evidence] Originals shall be obtained when documentary evidence is collected. Originals of documentary evidence obtained shall be marked with the obtaining date, names of the provider and law enforcement officials and bear the signatures or seals of the provider and law enforcement officials.
Where originals are difficult to obtain, they may be duplicated, scanned, or transcribed, and then the duplicated, scanned, or transcribed copies shall be marked with "verified to be the same with the originals", the source and obtaining time after being verified by the provider and the law enforcement officials and shall be signed or sealed by the provider or the witness and the law enforcement officials for confirmation.
Both the originals and copies of licenses or permits are originals and have the same probative effect.
......
December 7, 2017
In order to strengthen the law enforcement guidance for the food and drug supervision system and enhance the whole system's awareness of law enforcement evidence, the China Food and Drug Administration has drafted the Rules of Evidence in Food and Drug Supervision and Law Enforcement Activities (Draft for Comment), for which public comments are hereby sought. The public may give opinions via the following ways before January 6, 2018:
1. Log onto the website "China Legislative Information Network" at: http://www.chinalaw.gov.cn, and open the "Legislative Opinion Solicitation" column on the homepage to give your opinions.
2. Send your opinions by letter to the Legislative Department of the China Food and Drug Administration at Building 2, Courtyard No.26, West Street, Xuanwumen, Xicheng District, Beijing (Zip Code: 100053) and mark "Feedback Opinions on the Rules of Evidence in Food and Drug Supervision and Law Enforcement Activities" on the envelope.
3. Send your opinion by fax to: 010-88330782
Rules of Evidence in Food and Drug Supervision and Law Enforcement Activities (Draft for Comment)
Chapter I General Provisions
Article 1 [Purpose and Basis] In order to strengthen the food and drug supervision and administration, regulate the application of law enforcement evidence, and protect the legitimate rights and interests of citizens, legal persons or other organizations, the Rules of Evidence in Food and Drug Supervision and Law Enforcement Activities (Draft for Comment) (hereinafter referred to as the "Rules") are formulated in accordance with the Administrative Licensing Law of the People's Republic of China, the Administrative Coercion Law of the People's Republic of China, the Law of the People's Republic of China on Administrative Penalties, the Food Safety Law of the People's Republic of China, the Drug Administration Law of the People's Republic of China, the Regulations on the Supervision and Administration of Medical Devices, the Regulations on the Hygienic Supervision of Cosmetics and other laws and regulations and the relevant provisions, and in combination with the actual situation of food and drug supervision.
Article 2 [Scope of Application] Food and drug administrations shall comply with the Rules when collecting, examining and applying evidence in its supervision and administration.
Article 3 [Definition of Evidence] For the purpose of the Rules, evidence refers to materials used to prove specific facts relating to food and drug supervision and law enforcement and in line with legal formal requirements.
Article 4 [Principle for Fact Finding] Food and drug administrations shall take conclusive and adequate evidence as the basis for juristic fact finding when making specific administrative decisions according to legal procedures, standards and requirements.
Article 5 [Principle for Evidence Collection] Food and drug administrations and their law enforcement officials shall comprehensively, objectively, fairly and timely investigate and collect evidentiary materials related to specific administrative matters or cases.
Law enforcement officials shall carry out necessary examination and verification of the evidence submitted by the parties.
Article 6 [Principle for Evidence Examination] Food and drug administrations shall establish a sound system for the examination of evidence in administrative supervision and law enforcement activities to ensure the legitimacy, authenticity, relevancy and adequacy.
Article 7 [Principle for Evidence Use and Confidentiality] Food and drug administrations and their law enforcement officials may not use legally obtained evidence for any purpose other than administrative supervision and administration.
Evidence that relates to state secrets, business secrets or personal privacy or should be kept confidential as required by laws shall not be disclosed to the public. Where laws or regulations have separate provisions, such provisions shall prevail.
Article 8 [Principle for Evidence Disclosure] Where the relevant entities or individuals apply to food and drug administrations for disclosure of the relevant information on administrative supervision and law enforcement activities, disclosure shall be made according to the administrative provisions on the disclosure of government information.
Chapter II Evidence Collection
Section 1 Basic Requirements
Article 9 [Category of Evidence] Evidence in food and drug supervision and law enforcement activities mainly include: documentary evidence, physical evidence, audio-visual materials, electronic data, testimony of witnesses, statements of the parties, inspection reports, identification opinions, authentication opinions and on-site inspection records, etc.
Article 10 [Basic Requirements for Evidence Collection] Law enforcement officials of food and drug administrations shall abide by the following provisions when collecting evidence:
1. they shall have the corresponding law enforcement qualification when collecting evidence, and shall voluntarily show their law enforcement certificates.
2. they shall inform the administrative counterpart of the right to apply for withdrawal of law enforcement officials; and shall voluntarily withdraw if they have a direct stake in the parties or the investigation subject.
3. they shall notify the administrative counterpart to legally offer cooperation in the investigation and that if the administrative counterpart fails to truthfully provide evidence or testimony, or gives false testimony, or forges, conceals or destroys evidence, or obstructs the investigation, it shall bear the legal liability.
4. they shall not collect evidence in violation of statutory procedures, or by inducement, fraud, coercion, violence or other illegal means, or by infringing the legitimate rights and interests of others or violating legal prohibitive provisions.
Article 11 [Means of Evidence Collection] Food and drug administrations shall collect evidence by the following means:
1. entering food and drug production or operation places or other related places for on-site inspection;
2. investigating and inquiring about the parties or other relevant personnel, and listening to the statements and defenses of the parties;
3. checking food, drugs and the related products, raw materials, ingredients, additives, etc., and conducting sampling inspection, testing, quarantine or identification according to the relevant provisions;
4. sealing up or detaining food, drugs and the related products, tools, places and so on that may be suspected of being illegal or have hidden security risks;
5. first registering the evidence for preservation, or copying, duplicating, photographing, or making picture recordings of the evidence or taking other protective measures against the evidence in accordance with the law if there is a likelihood that the evidence may be lost or destroyed, or difficult to obtain at a later date;
6. collecting the relevant materials through official documents of state organs and other functional departments;
7. obtaining evidence from administrative licensing, product registration, system certification, and daily supervision and inspection records and other relevant materials;
8. collecting evidence by consulting the computer system or other electronic information recording equipment;
9. collecting evidence by accepting complaints, reporting and so on; and
10. collecting evidence by other means.
Section 2 Documentary Evidence
Article 12 [General Forms of Documentary Evidence] Documentary evidence mainly includes:
1. application, acceptance, evaluation and approval and other related materials, approval and certification documents, authentication certificates, archiving credentials and identification materials formed during the process of related administrative licensing, product registration and management certification;
2. the related contracts, bills, lists, books, records, documents, pictures, professional technical information, etc.;
3. announcements, notifications, circulars, official replies, investigation replies and other official documents issued by state organs and other functional departments according to their legal functions and powers, effective written judgments of people's courts or effective written arbitrations of arbitration agencies;
4. documents on administrative penalty, administrative adjudication, administrative reconsideration and other decisions made by food and drug administrations or other functional departments in accordance with the law, and inspection records and other written materials formed in the process of their supervision and law enforcement activities; and
5. other written materials that can prove specific facts.
Article 13 [General Requirements for Collecting Documentary Evidence] Originals shall be obtained when documentary evidence is collected. Originals of documentary evidence obtained shall be marked with the obtaining date, names of the provider and law enforcement officials and bear the signatures or seals of the provider and law enforcement officials.
Where originals are difficult to obtain, they may be duplicated, scanned, or transcribed, and then the duplicated, scanned, or transcribed copies shall be marked with "verified to be the same with the originals", the source and obtaining time after being verified by the provider and the law enforcement officials and shall be signed or sealed by the provider or the witness and the law enforcement officials for confirmation.
Both the originals and copies of licenses or permits are originals and have the same probative effect.
......