Provisions on the Procedures for Food and Drug Administrative Penalties

Order of the China Food and Drug Administration No. 3

April 28, 2014

The Provisions on the Procedures for Food and Drug Administrative Penalties which were deliberated and adopted at the executive meeting of the China Food and Drug Administration on March 14, 2014, are hereby promulgated and become effective as of June 1, 2014.

Director: Zhang Yong

Provisions on the Procedures for Food and Drug Administrative Penalties

Chapter I General Provisions

Article 1 In order to standardize the exercise of the administrative penalty power of the food and drug regulatory departments, and protect the legitimate rights and interests of citizens, legal persons and other organizations, these Provisions are formulated according to the Law of the People's Republic of China on Administrative Penalties (hereinafter referred to as the "Law on Administrative Penalties"), the Administrative Coercion Law of the People's Republic of China (hereinafter referred to as the "Administrative Coercion Law"), the Drug Administration Law of the People's Republic of China and other relevant laws and administrative regulations.

Article 2 The food and drug regulatory departments shall obey these Provisions when imposing administrative penalties on entities or individuals that violate the laws, regulations or rules regarding the administration of food, heath food, drugs, cosmetics or medical devices.

Article 3 When imposing administrative penalties, the food and drug regulatory departments follow the principles of openness, impartiality and fairness, and ensure that the facts are clear, evidence is conclusive, the procedures are lawful, the application of laws, regulations and rules are correct and the use of law enforcement documents is standard.

Article 4 With regard to an administrative penalty imposed by the food and drug regulatory department, a citizen, legal person or other organization has the right of statement or defense; and has the right to legally apply for an administrative reconsideration or initiate administrative proceedings in the event of dissatisfaction with such administrative penalty.

Article 5 The food and drug regulatory departments establish an administrative penalty supervision system.
A food and drug regulatory department supervises the administrative penalties imposed by the food and drug regulatory departments at lower level. A food and drug regulatory department orders the food and drug regulatory departments at lower level to correct their administrative penalty decisions that are illegal or inappropriate; or, if they fail to correct such decisions within a time limit, legally changes or cancels such decisions.

Chapter II Jurisdiction

Article 6 Administrative penalties are subject to the jurisdiction of the food and drug regulatory department at the place where illegal acts occur.

Article 7 The food and drug regulatory department of a county (district) or city (prefecture or autonomous prefecture) has jurisdiction over the food and drug administrative penalty cases within its administrative area according to its duties.
The food and drug regulatory department of a province, autonomous region or municipality directly under the Central Government has jurisdiction over the important or complex food and drug administrative penalty cases within its administrative area according to its duties.
The China Food and Drug Administration has jurisdiction, according to its duties, over the cases on which it shall impose administrative penalties and important or complex food and drug administrative penalty cases occurred nationwide.
The food and drug regulatory department of a province, autonomous region or municipality directly under the Central Government may, according to the laws, regulations and rules, and the local situation, set specific work under hierarchy-based jurisdiction within its administrative area.

Article 8 The food and drug regulatory departments at or above the county level may, within their statutory authority, entrust the organizations that meet the requirements provided in Article 19 of the Law on Administrative Penalties to impose administrative penalties.
An entrusted organization shall, within the scope of entrustment, conduct specific administrative acts in the name of an entrusted department. An entrusted department shall guide and supervise the administrative penalty acts of the entrusted organization and relevant administrative law enforcement acts thereof, and bear legal liability for the consequence of such acts.

Article 9 The dispatched food and drug regulatory office set by a food and drug regulatory department at the county level exercises the administrative penalty power according to the provisions of the laws, regulations and rules.

Article 10 Where more than two food and drug regulatory departments have jurisdiction over the same illegal act of the parties, the food and drug regulatory department that first initiates the case has jurisdiction over the case. Where there is a dispute over jurisdiction, such dispute shall be settled through consultation; if consultation fails, such dispute shall be reported to their common food and drug regulatory department at the next higher level for the designation of jurisdiction.

Article 11 A food and drug regulatory department, when deeming it necessary, may directly investigate and handle the cases under the jurisdiction of the food and drug regulatory departments at the lower level, or may transfer the cases under its jurisdiction to the food and drug regulatory departments at the lower level for investigation and handling.
Where a food and drug regulatory department fails to exercise jurisdiction over a case under its jurisdiction due to a special reason, such department may report the case to the food and drug regulatory department at the higher level for the exercise of jurisdiction or the designation of jurisdiction.

Article 12 After receipt of a jurisdiction dispute or request instruction on jurisdiction designation, the food and drug regulatory department shall, within ten working days, decide the designation of jurisdiction, and issue a written notice to the department at the lower level.

Article 13 Where a food and drug regulatory department discovers that a case is not under its jurisdiction, such department shall promptly transfer the case to the food and drug regulatory department with jurisdiction or relevant administrative department for handling.
The food and drug regulatory department to which the case is transferred shall promptly inform by letter the food and drug regulatory department which transfers the case of the result of the investigation and handling; or, when deeming such transfer inappropriate, shall report the case to their common food and drug regulatory department at the next higher level for the designation of jurisdiction, and shall not transfer the case again.

Article 14 Where a food and drug regulatory department discovers that an illegal act involves any crime when investigating and handling a case, such department shall promptly transfer the case to the public security authority according to the requirements of the Provisions on Transfer of Suspected Criminal Cases by the Administrative Law-Enforcement Organs.
Where the public security authority decides to initiate a case, the food and drug regulatory department shall, within three days upon receipt of a case initiation notice from the public security authority, transfer the articles involved in the case and other materials relating to the case to the public security, and complete the handover formalities; and shall complete a handover notice on seal-up or seizure of articles and inform the parties in writing of the same with respect to the sealed up or seized articles involved in the case.

Article 15 Where a food and drug regulatory department, at the time of handling an administrative penalty case, needs the assistance of the food and drug regulatory department of another area in conducting the investigation or evidence collection for the case, such department shall issue an investigation assistance letter. The assistant department shall, within 15 working days upon receipt of the investigation assistance letter, complete relevant work in general; and, if an extension is required, shall promptly inform the department filing the investigation assistance request of such extension.

Article 16 Where a food and drug administrative license is required legally to be revoked or an approval certification document is required legally to be cancelled, the originally issuing or approving food and drug regulatory department is to decide such revocation or cancellation.
Where a food and drug regulatory department is required legally to revoke a license or cancel an approval certification document when investigating or handling a case involving an illegal act, such department shall submit the evidence collected and relevant materials to the originally issuing or approving food and drug regulatory department while imposing an administrative penalty within its authority, and the originally issuing or approving department is to legally make an administrative penalty decision on whether or not to revoke the license or cancel the approval certification document. Where the China Food and Drug Administration is required to cancel the approval certification document, the food and drug regulatory department of a province, autonomous region or municipality directly under the Central Government is to report the case to the China Food and Drug Administration for decision.
Any administrative penalty decision made legally by the originally issuing or approving department on the revocation of a license or the cancellation of an approval certification document is subject to these Provisions.

Chapter III Case Initiation

Article 17 A food and drug regulatory department shall promptly investigate and handle the following matters:
1. the clue of a case discovered in the supervision, inspection or sampling inspection;
2. the complaint or report of a citizen, legal person or other organization;
3. an assignment by the organ at the higher level or an investigation and handling request by the organ at the lower level; and
4. the matter transferred or disclosed by other means or methods by a relevant department.
Where the requirements for case initiation are met, case initiation shall be made within seven working days.

Article 18 Case initiation shall meet the following requirements:
1. the suspect of an illegal act is clear;
2. there is the fact of illegality;
3. the case falls within the scope of supervision and administration of food and drug administrative penalties; and
4. the case is under the jurisdiction of the department.
Where the requirements for case initiation are met, it shall be reported to the in-charge responsible person for the approval for case initiation, and more than two law enforcement persons shall be determined as the case handling personnel.

Article 19 A case handling person shall withdraw voluntarily under any of the following circumstances; and the parties also have the right to apply for his or her withdrawal:
1. such person is a party to the case or a close relative of a party thereto;
2. such person has direct interest in the case; and
3. such person has other relation with a party to the case, which is likely to affect the impartial handling of the case.
The withdrawal of a case handling person is decided by the responsible person in charge of a food and drug regulatory department, and the withdrawal of a responsible person is decided by other responsible persons of such department through collective discussion.
Before a withdrawal decision is made, the person against whom a withdrawal application is made may not cease the investigation and handling of the case without approval.

Chapter IV Investigation and Evidence Collection

Article 20 When a food and drug regulatory department carries out a case investigation, the law enforcement personnel shall not be less than two persons, and shall present their law enforcement permits.
Where a law enforcement person collects or takes evidence from a party to the case for the first time, such law enforcement person shall inform such party that the party has the right to apply for the withdrawal of a case handling person.
The investigated person or relevant personnel shall faithfully answer inquires and provide assistance or coordination in the investigation, and promptly the bills, vouchers, records and relevant materials that shall be preserved legally, and shall not hinder or interfere in the investigation of the case.
Where any State secret, trade secret or privacy is involved in the course of case handling, the law enforcement personnel shall keep it confidential.

Article 21 When a law enforcement person conducts on-site investigation, such person shall make a written record. Such record shall state the identity of the law enforcement person, certificate name, certificate number, and investigation purpose. The law enforcement person shall sign such record.
After a record is certified correct, the investigated person shall sign or make a fingerprint on each page of the record, and, on the record, indicate his or her opinion on the authenticity of the record. The investigated person shall sign or make a fingerprint on any revision in the record.

Article 22 A case handling person shall legally collect the evidence relating to the case. Evidence includes, among others, documentary evidence, physical evidence, audio-visual material, witness testimony, statement of a party, inspection report, authentication opinion, investigation record, electronic data, record of on-site inspection.
Any evidence legally obtained in the course of investigation or examination prior to case initiation may be taken as the basis for ascertaining the facts.

Article 23 The evidence taken shall be the originals. If it is difficult to take the originals, the entity or individual that submits the evidence may sign or seal the reproduction and indicate such words or literal description as "This reproduction is provided by XXX and, upon verification, is identical to the original one".

Article 24 With regard to any evidence formed outside the territory of the People's Republic of China, the source thereof shall be stated, certified by a notary organ of the country where such evidence is located, and authenticated by an embassy or consulate of the People's Republic of China in that country, or the certification formalities provided in relevant treaty concluded by and between the People's Republic of China and the country where such evidence is located shall be gone through.
The language or words included in overseas evidence shall be provided with the accurate Chinese version translated by a qualified translation organization or any other translator.
With regard to evidence formed in the Hong Kong Special Administrative Region or Macao Special Administrative Region of the People's Republic of China or Taiwan region, the certification formalities shall be gone through according to relevant provisions.

Article 25 Under the circumstance where evidence might be damaged or lost or be difficult to be obtained in the future, such evidence may be registered and preserved in advance upon approval from the in-charge responsible person, and a notice on prior registration and preservation of the article is to be given to the party concerned. During the period of prior registration and preservation, the party or relevant personnel may not damage, destroy or move such evidence.

Article 26 A food and drug regulatory department shall, within seven days, make a decision as below in respect of the handling of evidence that is registered and preserved in advance:
1. where it is necessary to take evidence preservation measure, such evidence is to be returned after taking such evidence preservation measure as record, reproduction, photograph or visual recording;
2. where the inspection, testing, quarantine or authentication is required, such evidence is to be delivered for inspection, testing, quarantine or authentication;
3. where such evidence is legally required to be confiscated, an administrative penalty decision is to be made to confiscate relevant illegal articles;
4. where seal-up or seizure is required, the measure of seal-up or seizure is to be taken legally; and
5. where the fact of illegality is not tenable, or the fact of illegality is tenable but seal-up, seizure or confiscation is not legally required, the measure of prior registration and preservation of is to be terminated.
Where a decision on the handling thereof fails to be made within a time limit, the prior registration and preservation shall be terminated.

Article 27 When a food and drug regulatory department conducts a case investigation, such administrative enforcement measures as seal-up and seizure may be legally taken upon approval from the in-charge responsible person, and the law enforcement personnel shall issue a written decision on seal-up or seizure to the parties concerned.
Where an emergency requires the measure of seal-up or seizure to be taken on the spot, the law enforcement personnel shall, within 24 hours after seal-up or seizure, report the same to the in-charge responsible person, and complete the omitted approval formalities. Where the in-charge responsible person believes that no administrative enforcement measure shall be taken, such measure shall be terminated immediately.

Article 28 When a food and drug regulatory department imposes prior registration and preservation or seal-up or seizure, such department shall notify the parties of being present, and state relevant measures taken in the record of on-site inspection.
Such department shall affix paper strips with its official seal to the sealed up or seized place, facility or property locally or non-locally, and the parties shall not unseal them without approval.
With regard to the articles that are subject to prior registration and preservation or seal-up or seizure, a list of such articles shall be made, and the law enforcement personnel, the parties or relevant personnel shall sign or seal such list.

Article 29 The sealed up or seized place, facility or property shall be kept properly, and shall not be used, damaged or destroyed or, without approval be moved or handled.
With regard to perishable articles, if a law or regulation provides that such articles may be directly handled in advance, or if the parties agree to handle such articles in advance, such articles may be handled in advance upon approval from the responsible person in charge of the food and drug regulatory department after relevant measures are taken for evidence preservation.

Article 30 The time limit for seal-up or seizure shall not exceed 30 days; or, if the circumstance is complex, may be extended upon the approval from the responsible person in charge of the food and drug regulatory department, provided that such extension shall not exceed 30 days.
After a decision on extending the time limit for seal-up or seizure is made, a notice on deferring the seal-up or seizure shall be completed promptly to inform the parties in writing of the same and to state the reason thereof.
Where an article needs to be inspected, tested, quarantined or authenticated, an inspection (testing, quarantine or authentication) notice shall be completed. The period of seal-up or seizure does not include that of inspection, testing, quarantine or authentication.
Where the provisions of Article 28 of the Administrative Coercion Law are met, seal-up or seizure shall be terminated.

Article 31 Where the law enforcement personnel, in the course of investigation and evidence collection, require the parties to affix their signature or seal to or make confirmation otherwise on the record or other materials, and the parties refuse to be present or to affix their signature or seal to or make confirmation otherwise, or the parties fail to be found, two law enforcement persons shall state the reason thereof on the record or other materials, and relevant personnel shall be invited to affix their signature or seal thereto as the witnesses, or such means as sound or visual recording may be taken to record.

Article 32 Where the law enforcement personnel investigate the fact of illegality and need to conduct sampling inspection, samples shall be chosen according to relevant provisions. An inspection institution shall conduct the inspection promptly within a specified time limit.

Article 33 After completing a case investigation, the case handling person shall prepare an investigation completion report, except for the summary procedure. Such investigation completion report covers: basic information of the parties, cause of action, the fact of illegality and evidence, investigation course, etc.; if an administrative penalty is to be imposed, shall also cover the basis as applied and penalty proposal.

Article 34 Where evidence shows that there is an illegal act when a food and drug regulatory department conducts a case investigation, such department shall issue a notice on an order to make corrections, ordering the parties to correct such illegal act or to do so within a time limit.

Chapter V Penalty Decision

Section 1 General Procedures

Article 35 After a case handling person submits the case completion report, the food and drug regulatory department shall organize more than three relevant persons to conduct a panel discussion on the fact, nature, particular, severity of social harm, case handling procedure, penalty proposal, etc. of such illegal act.
A panel discussion shall, based on the fact ascertained, put forward such handling opinion as imposing a penalty, supplementing evidence, conducting a new investigation, or cancelling the case.

Article 36 Before making a penalty decision, the food and drug regulatory department shall complete a prior notice on administrative penalty, informing the parties of the fact of illegality, and the reason and basis of the penalty, as well as the right of statement or defense that is enjoyed legally by the parties.
The food and drug regulatory department shall fully hear the statements and defense of the parties. Where the fact, reason or evidence raised by a party is tenable upon review, they shall be adopted.
The food and drug regulatory department may not impose cumulative penalty on a party due to the defense of such party.

Article 37 Before making a decision on administrative penalty such as ordering to suspend the production or operation, revoking the license, cancelling the approval certification document, a fine of relatively large amount, or confiscating property of relatively large amount, the food and drug regulatory department shall inform the parties of their right to request for a hearing. Where a party requests for a hearing, such hearing shall be organized according to the statutory procedures.
The standard for a fine of relatively large amount is subject to the provisions of local regulations, local governmental rules and other relevant regulatory documents.

Article 38 A proposed administrative penalty decision shall be reported to the responsible person of a food and drug regulatory department for review. The responsible person of a food and drug regulatory department is to make a decision as below according to the circumstances:
1. where there is an illegal act for which an administrative penalty shall be imposed, the administrative penalty decision is to be made according to the seriousness of the particular and specific circumstance;
2. where the illegal act is minor and an administrative penalty may be refused legally to be imposed, such administrative penalty is to be refused to be imposed;
3. where the fact of illegality is not tenable, an administrative penalty shall not be imposed; and
4. where the illegal act constitutes a crime, the case is to be transferred to the public security authority.

Article 39 With regard to an administrative penalty that is imposed for an illegal act with complex particular or a major illegal act, the responsible person of a food and drug regulatory department shall decide it upon collective discussion. The course of a collective discussion shall be recorded in writing.
The standards for major or complex cases are determined by the food and drug regulatory department of a province, autonomous region or municipality directly under the Central Government according to its actual situation.

Article 40 A food and drug regulatory department shall prepare a written administrative penalty decision when making an administrative penalty decision.
A written administrative penalty decision shall state the following matters:
1. the name and address of a party;
2. the fact of a violation of a law, regulation or rule and the evidence;
3. the type and basis of the administrative penalty;
4. the performance method and period of the administrative penalty;
5. the way and period for applying for an administrative reconsideration or initiating administrative proceedings due to dissatisfaction with the administrative penalty; and
6. the name of the food and drug regulatory department that makes the administrative penalty decision and the date on which such decision is made.
Where the administrative penalty decision involves confiscated food or drug or other relevant articles, the receipt of such confiscated articles shall also be attached thereto.
The official seal of the food and drug regulatory department that makes the administrative penalty decision shall be affixed to the written administrative penalty decision.

Article 41 Except for articles that shall be destroyed legally, the food and drug regulatory department, upon approval from the in-charge responsible person, is to handle unlawful property legally confiscated according to Article 53 of the Law on Administrative Penalties. The type and quantity of handled articles shall be verified, and a list of such articles be completed.

Section 2 Summary Procedure

Article 42 Where the fact of illegality is irrefutable and has a legal basis and the administrative penalty of a fine of less than CNY50 for a citizen or of a fine of less than CNY1,000 or a warning for a legal person or other organization is imposed, the administrative penalty decision may be made on the spot.

Article 43 Where a law enforcement person makes an administrative penalty decision on the spot, such law enforcement person shall present his or her law enforcement permit to a party, and complete a written on-site administrative penalty decision with predefined format, serial number and the official seal of the food and drug regulatory department.
The written on-site administrative penalty decision shall be delivered to the party on the spot, and the party shall sign for the decision by affix his or her signature or seal thereto.

Article 44 Any administrative penalty decision made by a law enforcement person on the spot shall be reported to the department with which such person is affiliated within seven working days.

Chapter VI Service

Article 45 A written administrative penalty decision shall, after pronouncement, be delivered on the spot to a party; or, where the party is not present, shall be served on the party within seven days according to this Chapter.
The written administrative penalty decision is delivered directly by the handling person to the party for signing for the decision. Where the addressee is a citizen and the citizen is absent, the decision is to be delivered to his or her adult family member who lives together for signing for the decision; where the addressee is a legal person, its legal representative shall sign for the decision; where the addressee is any other organization, its principal shall sign for the decision. Where the addressee has an agent, the decision may be delivered to the agent for signing for the decision.
The addressee shall indicate the date of receipt on the acknowledgement receipt and sign or seal such receipt. The date on which the address signs for the decision is the date on which the decision is served.

Article 46 Where an addressee or his or her adult family member who lives together refuses to accept a written administrative penalty decision, the person serving the decision may invite the personnel from relevant basic-level organization or the entity that such person works with to be present and to state the situation, and indicate the reason and date for such refusal on the acknowledgement receipt which is signed or sealed by the person serving the decision and the witnesses, and leave the written administrative penalty decision at the domicile of the addressee, namely, such written administrative penalty decision is to be deemed to have been served on the addressee.

Article 47 Where direct service is difficult, the service may be made by entrusting a food and drug regulatory department nearby or by mail. In the event of service by mail, the date of acceptance indicated on the acknowledgement receipt is the date on which the service is made.
An administrative penalty of cancelling a food and drug approval certification document imposed by the China Food and Drug Administration is to be served by the food and drug regulatory department of a province, autonomous region or municipality directly under the Central Government where the party is located.

Article 48 Where an addressee's whereabouts is unknown, or the service fails to be made by other means specified in this Chapter, the service is to be made by public announcement. The service is deemed to have been made in 60 days from the day on which the public announcement is made.
In the event of service by public announcement, the public announcement may be posted at the original domicile of the addressee or the public announcement may be published in newspaper or television, etc.
In the event of service by public announcement, the reason and course of the service by public announcement shall be stated in the files.

Chapter VII Enforcement and Case Closing

Article 49 After the service of a written administrative penalty decision, the party shall perform the decision within the time limit specified in the penalty decision.
Where the party has financial difficulty indeed, the party may apply for deferring the payment of a fine or paying a fine by installation, and submit written materials. Upon review by the case handling person, the time limit and amount of the deferred fine or fine paid by installation are to be determined, and be enforced upon approval from the in-charge responsible person.

Article 50 Where a party is dissatisfied with an administrative penalty decision and thus applies for an administrative reconsideration or initiates administrative proceedings, the enforcement of such administrative penalty is not to cease, except where a decision or ruling is made during the period of administrative reconsideration or administrative proceedings to cease such enforcement.

Article 51 The food and drug regulatory department that makes a decision on imposing a fine and confiscating illegal gains shall be separate from the agency that collects fines and forfeitures. Except for the fines collected on the spot according to the provisions, no law enforcement personnel may collect any fine or forfeiture by themselves.

Article 52 Where an administrative penalty decision made on the spot according to these Provisions is under any of the following circumstances, the law enforcement personnel may collect a fine on the spot:
1. a fine of less than CNY20 is imposed legally; and
2. it is difficult to collect a fine in the future in the event of failure to do so on the spot.

Article 53 Where in an area that is remote, on water or inaccessible, after a food and drug regulatory department or its law enforcement personnel make a penalty decision according to these Provisions, the party indeed has difficulty in paying a fine to the designated bank, the law enforcement person may collect the fine on the spot upon request by the party.

Article 54 Where a food and drug regulatory department or its law enforcement personnel collect a fine on the spot, they shall issue a fine receipt printed in a unified manner by the finance department of a province, autonomous region or municipality directly under the Central Government to the party.
A fine collected on the spot by a law enforcement person shall be delivered to the food and drug regulatory department within two days from the day of collection of the fine; and the food and drug regulatory department shall pay such fine to a designated bank within two days.

Article 55 Where a party, within a statutory time limit, neither applies for an administrative reconsideration or initiate administrative proceedings nor performs the administrative penalty decision, the food and drug regulatory department shall apply to the people's court for enforcing the decision.
Before applying to the people's court for enforcing an administrative penalty decision, the food and drug regulatory department shall complete a written notice demanding the performance of such decision, requiring the party to perform the duty, and informing the time limit and method of the performance of the duty, the rights of statement and defense legally enjoyed, and, if an additional fine is involved, shall specify the amount and payment method.
The total amount of an additional fine shall not exceed the amount of the original fine.
Where the party makes a statement or defense, the food and drug regulatory department shall record and review the fact, reason and evidence put forward by the party, and prepare the statement or defense record and the statement or defense review opinion. Where the fact, reason or evidence put forward by the party is tenable, the food and drug regulatory department shall adopt it.
Where the party still fails to perform the administrative penalty decision ten working days after a notice demanding the performance of the penalty decision, the food and drug regulatory department may apply to the people's court for enforcement, and complete the written administrative penalty enforcement application.

Article 56 After the performance or enforcement of an administrative penalty decision, the case handling person shall complete a case closing report for the administrative penalty, and process and bind relevant case materials for archiving and preservation.

Chapter VIII Supplementary Provisions

Article 57 In these Provisions, a time limit is calculated based on hour or day, excluding the starting hour or day. Where the last day of the expiry of a time limit is a holiday, the first day following such holiday is the date of expiry, unless otherwise provided in by the laws and regulations.

Article 58 In these Provisions, the terms "more than", "less than" and "within" include the given figures.

Article 59 The food and drug regulatory department of each province, autonomous region or municipality directly under the Central Government may, according to the actual situation of its administrative area, formulate the detailed implementing rules for these Provisions.

Article 60 The China Food and Drug Administration is responsible for formulating the model formats of instruments applicable to administrative penalties. The food and drug regulatory department of each province, autonomous region or municipality directly under the Central Government may, by referring to such model formats of instruments, formulate the formats of instruments applicable to administrative penalties within its administrative area and print such formats by itself.

Article 61 These Provisions become effective as of June 1, 2014. The Provisions on the Drug Administrative Penalty Supervision Procedures (Order No. 1 of the former State Food and Drug Administration) promulgated on April 28, 2003 shall be repealed simultaneously.