Drug procedural requirements for administrative penalties Wikipedia card "Drug procedural requirements for administrative penalties" on April 28, 2003 by Food and Drug Administration Order No. 1 announced; according to October 17, 2012 The People's Republic of China Ministry of Health Order No. 88 "About modification's decision" amendment. The "rule" of general principles, jurisdiction, filing, investigation, punishment decision, execution and closing, Annex 7 Chapter 64, since July 1, 2003 shall come into force. Abolition of August 1, 1999 the State Drug Administration Order No. 8 promulgated the "Administrative Punishment Drug Program."
two, the third Paragraph 4 is amended as: "the implementation of administrative penalties, administrative enforcement and the principle of combining education."
three, Article 10, an increase of two, respectively, as the second and third paragraphs, namely: "The drugs, medical devices illegal cases suspected of a crime, drug supervision and administration department shall, within two working days of complete" refer the case for approval "(Schedule 1), the drug regulatory department head immediately after the approval of the leadership fill in the" suspected criminal cases transferred to the book "(new Schedule 1) transferred to the public security organs at the same level, with a copy to the same level People's Procuratorate and send a copy to the drug regulatory department superiors.
"decision to initiate the public security organs, the drug regulatory department shall, within three working days will be seized or detained goods handed over to the filing of the public security organs, and should fill out the" seizure (seizure) goods transferred Notice "( new Schedule 2), and inform the parties in writing. "
Four, Article 22 of the "" sequestration items for approval "(Schedule 9)", "" notice of seizure seizure of items "(Schedule 10)" were revised as follows: "'seizure (seizure) for approval "(Schedule 9)", "" seizure (seizure) decision "(Schedule 10)."
five, the first paragraph of Article 23 is amended as: "the drug regulatory departments to implement advanced registration and preservation or seizure, detention, it shall notify the parties present, and in the" site inspection record "in the taking of the relevant measures to be recorded case the parties are not the scene, law enforcement officers invited to witness the scene, the witnesses and law enforcement officers at the scene signed or sealed. "
six, the Article 24 is amended as: "the drug regulatory department of the cases that have been filed shall fill out the" notice filing "(Schedule 13), delivery of the parties.
"for advanced registration and preservation of the goods, it shall make a decision within seven days. pair seizure, seizure of goods, shall be filed within seven days after the decision is made whether; need to be inspected, the inspection report shall be issued from the date of 15 days to decide whether to file a case decision.
"seizure, detention period not exceeding 30 days; situation complicated, drug supervision and management departments should fill out the" seizure (seizure) Extension for approval "(new Schedule 3), the competent leadership Drug Administration approval can be extended, but the extension period shall not exceed 30 days; make extended seizure, detention period, the decision shall be promptly fill out the "seizure (seizure) Extension Notice" (new Schedule 4), inform the parties in writing and explain the reasons; right Items needed for testing, inspection or technical appraisal shall fill in "test (testing, technical appraisal) this book" (new Schedule 5), seizure, detention period does not include testing, inspection or technical appraisal period.
"filing does not meet the conditions, drug supervision and management departments should fill out the" register and keep goods lifting Notice "(Schedule 14), register and keep lifting, or fill in the" lift the seizure (seizure) decision "( Schedule 15), lift the seizure, seizure. "
seven, twenty-five will be amended as: "Drug law enforcement officers to investigate illegal facts, you need to identify the test sample shall be in accordance with the State Drug Administration departments to develop drugs or medical devices quality supervision and testing management provisions required sample. inspection agency shall promptly within the timeframe identified test. "
eight, Article 59 will be amended as follows: "The parties within the statutory time limit does not apply for administrative reconsideration or bring an administrative lawsuit, nor perform the administrative punishment decision, the drug regulatory department can customize the date of expiry of the three months' People's Court for enforcement.
"drug supervision and management departments to apply to court for enforcement ago should fill out the" perform the administrative penalty decision summon book "(new Schedule 6), written summon the parties to fulfill their obligations, obligations to inform the duration and manner, plus a fine of standards, shall enjoy the presentation and defense rights plus a fine of the total amount does not exceed the original amount of the fine the parties to make a statement, defense, and drug supervision and administration department shall make a "statement of defense transcripts" (Schedule 19), recording the parties propose facts, reasons and evidence, and produced "stated defense review submissions," (new Schedule 7) The parties put forward the facts, reasons or evidence is established, drug supervision and administration department shall adopt.
"" perform the administrative penalty decision summon book "served 10 days, the parties have not complied with the decision, the drug regulatory department may apply to court for enforcement, and fill out the" administrative penalties to enforce application "(Schedule 34). "
IX Schedule for the following modifications:
(a) by adding the following Schedule.
1. suspected criminal cases transferred to the book (new Schedule 1);
2. seizure (seizure) goods transferred notice (new Schedule 2);
3. seizure (seizure) Extension Approval Form (new Schedule 3);
4. seizure (seizure) extension notice (new Schedule 4);
5. inspection (testing, technical appraisal) Notification (new Schedule 5);
6. perform the administrative penalty decision summon books (new Schedule 6);
7. statement plead review submissions (new Schedule 7).
(two) to update the following table.
1. Schedule 9 "sequestration items for approval" is amended as: "seizure (seizure) for approval";
2. Schedule 10 "sequestration items notice" was changed to: "seizure (seizure) decision";
3. Schedule 13 "administrative processing notice" was changed to: "notice filing";
4. Schedule 15 "Unlock Items sequestration notice" was changed to: "lift the seizure (seizure) decision."
This decision shall enter into force from the date of publication. "Drug procedural requirements for administrative penalties," according to this decision be amended accordingly and re-released. [1] Edit this paragraph Drug procedural requirements for administrative penalties (April 28, 2003 Food and Drug Administration announced Decree No. 1, according to October 17, 2012 the Ministry of Health "on Amending decision "The Ministry of Health [88] Decree amended.) Edit this paragraph Chapter I General Provisions Article 1 In order to ensure proper exercise of the drug regulatory department administrative penalty authority, protection of citizens, legal persons and other organizations of the legitimate rights and interests, according to the" PRC Administrative Punishment Law, "" Administrative Enforcement Law "," Drug Administration Law "," Drug Administration Law Implementing Regulations, "" Supervision and Regulation of Medical Devices "and the State Council administrative regulations formulated regulations.
second violation of the drug regulatory department of medicines, medical equipment management laws, regulations, rules or individual units to impose administrative penalties, the application of this requirement.
Article Drug Administration to impose administrative penalties, must adhere to the following principles:
(a) the principles of statutory basis;
(two) the principle of legal procedures;
(three) fair and open manner;
(four) to impose administrative penalties, administrative enforcement and the principle of combining education;
(five) protection of citizens, legal persons and other organizations of the legitimate rights and interests principle.
Article IV drug regulatory departments shall establish administrative penalties supervision. Parent drug regulatory departments of pharmaceutical supervision and management departments to implement subordinate administrative penalties supervision. Parent drug regulatory departments of pharmaceutical supervision and management departments subordinate to the administrative penalty decision illegal, may be ordered to make corrections; overdue correction, the right to alter or rescind. [1] Edit this paragraph Chapter II Jurisdiction Article medicines, medical equipment supervision and management of administrative penalties by the offense took place in the drug regulatory department of jurisdiction.
above the county level drug regulatory department under the jurisdiction area of medicines, medical equipment administrative penalty cases.
provinces, autonomous regions and municipalities under the jurisdiction of the drug regulatory department within the jurisdiction of major and complex medicines, medical equipment administrative penalty cases.
jurisdiction of the State Drug Administration departments across the country have a significant impact of drugs, medical equipment administrative penalty cases.
provinces, autonomous regions and municipalities drug regulatory authority can be based on medicines, medical equipment management laws, regulations, rules and reality in the region to provide a specific level of jurisdiction within the jurisdiction of the division.
Article VII of two or more drug supervision and management departments of the disputed jurisdiction and report on a common drug regulatory department designated jurisdiction.
Article VIII Drug Administration found that cases do not belong to the department head or jurisdiction, it shall fill out the "case to approval" (Schedule 1), the drug regulatory department immediately after approval from the competent leadership fill out the "transfer of cases book "(Schedule 2), and the relevant case material shall be handed Drug Administration has jurisdiction over the department or the relevant administrative departments. Affected by the transfer of drug supervision and administration department shall be promptly communicated to the transfer case investigation results of cases the drug regulatory department.
affected by the transfer of drug supervision and administration department if deemed transferred improperly, shall be submitted on a common drug supervision and management departments designated jurisdiction, shall not be transferred again.
superiors after receiving the drug regulatory department under the jurisdiction of the dispute or report to the designated jurisdiction referrals shall, within 10 working days of the decision made by the designated jurisdiction.
Article IX subordinate Drug Administration within the jurisdiction of cases that should not be handled by the department, it may report the drug regulatory department under the jurisdiction or the designated jurisdiction. Parent drug regulatory department that subordinate Drug Administration should deal with cases within their jurisdiction, can decide their own jurisdiction or specify other subordinate Drug Administration jurisdiction.
Article drug regulatory department of the cases, we found that involving other drug regulatory department under the jurisdiction of the offense, should be completed with reference to the provisions of Article VIII of relevant instruments, together with the relevant evidence shall be handed over to the Drug Administration department. Has jurisdiction over the drug regulatory department of the transfer of the case shall be promptly investigated.
for drugs, medical devices illegal cases suspected of a crime, drug supervision and administration department shall, within two working days fill out the "case to approval" (Schedule 1), the drug regulatory authority approval of the competent leadership immediately after filling "suspected criminal cases transferred to the book" (new Schedule 1) transferred to the public security organs at the same level, with a copy to the same level People's Procuratorate and send a copy to the drug regulatory department superiors.
decision to initiate the public security organs, the drug regulatory department shall, within three working days will be seized or detained goods handed over to the filing of the public security organs, and should fill out the "seizure (seizure) goods transferred Notice" (New increase Schedule 2), and inform the parties in writing.
Article XI shall be revoked according to law "drug production license", "Drug License", "medical preparations license", "Medical Device Manufacturing Enterprise License", "Medical Device Distribution Enterprise License" , revoke the pharmaceutical, medical device approval documents, the original issuing Approved Drug Administration decision.
Drug Administration investigation of illegal cases, according to law shall be revoked "drug production license", "drug business license", "medical preparations license", "Medical Device Manufacturing Enterprise License", "Medical Device Distribution Enterprise License "revoke the pharmaceutical, medical device approval documents, within its mandate, to make administrative punishment according to the law at the same time, the evidence should be obtained and related materials submitted to the original issuance of the drug regulatory agency, the original issuing permit drug regulatory department shall decide whether or not revoke the license or revoke the approval documents of the administrative penalty decision.
required by the State Drug Administration revoked medicines, medical equipment approval documents, provinces, autonomous regions and municipalities drug regulatory department submitted to the State Drug Administration, the State Drug Administration department shall promptly make a decision .
original issuance of drug supervision and administration department shall revoke the license to make and revoke the approval documents of the administrative penalty decision must be based on the requirements.
drug supervision and administration department shall revoke that law "medical institution", and should be recommended for certification of health administrative authorities revoked.
Article XII belongs PLA units and individuals in violation of drug administration laws, regulations, rules of behavior, by the military Drug Administration based on "implementing the PLA Article XIV Drug Administration found violations of the following conditions shall be filed within seven working days:
(a) there is a clear violation suspects;
(two) there is objective illegal facts;
(three) belongs to the drug regulatory scope of administrative penalties;
(four) belonging to the jurisdiction of the department.
decide to initiate and should fill out the "Application Form for filing" (Schedule 4), reported department heads leadership instruction, approved the filing should identify two or more cases of drug supervision and law enforcement officers as contractors.
Article 15 of the following circumstances, the contractor for the case can not be determined by:
(a) is a party to the case or the parties are near relatives;
(two) with a direct interest in the case;
(three) parties have other relationships with the case, it may affect the impartial handling of the case. [1] Edit this paragraph Article XVI Chapter investigation conducted case investigation or inspection, the law enforcement officer shall not be less than two persons and shall provide the person being investigated or the relevant personnel present their certificates.
person being investigated or the officer shall truthfully answer questions and assist in the investigation or inspection, shall not obstruct.
involving state secrets, as well as the person being investigated business, technical secrets and personal privacy, the contractor shall keep a secret.
Article XVII between drug regulatory authorities investigate cases involving the situation, assist in the investigation mutual responsibility, the obligation to provide relevant evidence.
Article XVIII investigation by law enforcement officials, should fill out the "investigative records" (Table 5).
investigative records shall indicate the start of the identity of law enforcement personnel, document name, document number and investigation purposes. Law enforcement officers should be signed at the end of the investigation record.
investigative records is verified,Sale Nike Mercurial Glide III IC GS Black Fluorescent Green Soccer Cleats 2013 , after being investigated in the record shall be signed or fingerprinted by page, and in the record indicated on the transcript at the end of the authenticity of the comments. Transcripts modification office, shall be signed by the person being investigated or fingerprinted.
respondents refused to sign or press the fingerprints shall be conducted by two or more law enforcement officers to sign the transcript and indicate the circumstances.
Article XIX law enforcement officers carry out spot checks, it should fill the spot "site inspection record" (Table 6).
inspection record shall indicate the start of the identity of law enforcement personnel, document name, document number and inspection purposes. Law enforcement officers should be signed at the end of the inspection record.
inspection record is verified, after being checked in the record shall be signed or fingerprinted by page, and in the record indicated on the transcript at the end of the authenticity of the comments. Transcripts modification office, shall be signed by the person being checked or fingerprinted.
who refused to sign or be checked by fingerprints shall be conducted by two or more law enforcement officers to sign the transcript and indicate the circumstances.
Article XX Taking of evidence should be original, original. The transfer of the original, the original is really difficult, the evidence submitted by the entity or individual copies signed or stamped, and marked "with the original (object) the same," the words or text.
twenty-one who can show the true circumstances of the case documentary evidence, physical evidence, audiovisual materials, witness testimony, statements by the parties, inspection reports, conclusions, investigative records, transcripts and other on-site inspection for evidence of drug supervision and management of administrative punishment .
Article 22 evidence may be lost, or difficult to obtain in the case, law enforcement officers should fill out the "advanced registration and preservation items for approval" (Schedule 7), reported the competent leadership Drug Administration approval. Advanced registration and preservation items, law enforcement officers should be issued to the parties' advance notice of registration and preservation of goods "(Table 8).
drug supervision and management departments there is evidence that may harm human health pharmaceutical and related materials and the quality of medical devices have caused an accident or an accident may cause medical device quality products and relevant information, may be legally taken seizure, seizure of administrative enforcement measure. Law enforcement officers seized or detained goods before should fill out the "seizure (seizure) for approval" (Schedule 9), reported the competent leadership Drug Administration approval. Seizure, detention items, law enforcement officers should be issued to the parties' seizure (seizure) decision "(Schedule 10).
Twenty-three drug supervision and management departments to implement advanced registration and preservation or seizure, detention, it shall notify the parties present, and in the "site inspection record" in the case of measures, to be recorded. Parties do not scene, law enforcement officers invited to witness the scene, the witnesses and law enforcement officers at the scene signed or stamped.
seized or detained goods, you should use the official seal stamped with the department's "× × × Drug Administration seal" (Schedule 11), in situ or off-site storage items.
for advanced registration and preservation or seizure, the seized items should be listed in "() Items List" (Schedule 12), by law enforcement officers, signed by the parties or the officer or official seals.
parties refused to sign, seal, or received shall be conducted by two or more law enforcement officers on the list, signed and dated situation.
Twenty-four drug supervision and management departments should fill out a case has been filed "notice filing" (Schedule 13), delivery of the parties.
for advanced registration and preservation of goods, shall make a decision within seven days. For seized or detained goods, should be made within 7 days of the decision whether to file a case; need to be inspected, the inspection report shall be issued within 15 days from the date of making the decision whether to file a case.
seizure, detention period not exceeding 30 days; situation complicated, drug supervision and management departments should fill out the "seizure (seizure) Extension for approval" (new Schedule 3), the competent leadership Drug Administration approval, may be extended, but the extension period shall not exceed 30 days; make prolonged seizure, detention period, the decision shall be promptly fill out the "seizure (seizure) Extension Notice" (new Schedule 4), inform the parties in writing and explain the reasons; right items need for testing, inspection or technical appraisal should fill out the "inspection (testing, technical appraisal) this book" (new Schedule 5), seizure, detention period does not include testing, inspection or technical appraisal period.
filing does not meet the conditions, drug supervision and management departments should fill out the "register and keep goods lifting Notice" (Schedule 14), register and keep lifting, or fill in the "lift the seizure (seizure) decision" (attached Table 15), lift the seizure, seizure.
Article 25 Drug law enforcement officers to investigate illegal facts, you need to identify the test sample shall be according to the State Drug Administration departments to develop drugs or medical devices quality supervision and testing sample management requirements. Inspection agency shall promptly within the timeframe identified test.
Article 26 investigation has been concluded, the contractor shall write case end of the investigation reports. Its content should include the cause of action, the case, illegal facts, evidence handling procedures, in violation of laws, regulations or rules specific section, subsection, item, project, penalties proposed and signed by other contractors. (Except summary) [1] Edit this paragraph CHAPTER penalty decision procedure of Article 27 Section I General contractors submit cases end of the investigation report, the drug regulatory departments shall organize three or more violations of the relevant personnel facts, nature, circumstances, extent of social harm, handling procedures, etc. collegial, and fill out the "case collegiate record" (Schedule 16). Collegial should be based on identified illegal facts, in accordance with relevant medicines, medical equipment management laws, regulations and rules, respectively, deal with the views put forward the following:
(a) illegal facts are clear,Football Boots Soccer Cleats Shoes 2013 Limited Edition Nike Mercurial Vapor IX CR SE FG Fluorescent green pink , the evidence is conclusive, the program legal, administrative punishment according to law put forward opinions on there can not be punished, a lighter or mitigated punishment or aggravating circumstances presented no punishment, lighter or mitigated punishment or be punished severely opinion, constitutes a crime, an administrative penalty in the comments also suggested transferred to judicial organs be held criminally responsible;
(two) illegal facts are unclear, insufficient evidence, or the presence of bugs, and supplementary materials relevant evidence or re-investigation of the views;
(three) illegal facts can not be established, the proposed Withdrawn and fill out the "Withdrawn Application Form" (Schedule 17).
Article 28 The drug regulatory authority shall, before making the decision on punishment fill in the "Administrative Punishment ADVISED book" (Schedule 18), inform the parties of illegal facts, reasons and basis for punishment, and the parties are legally entitled to representation, defense rights.
drug supervision and management departments should fully listen to the statements of the parties and the defense and fill the spot "statement plead record" (Schedule 19), the parties presented the facts, reasons or evidence established by the review should be adopted.
drug supervision and administration department shall not impose heavier penalties on parties to defend themselves.
for hearing cases required by law, drug supervision and management departments to fulfill this obligation and the parties to exercise their prior statements, defense rights, in accordance with the provisions of Section II of this chapter.
Article 29 illegal facts are clear, the evidence is conclusive, legal procedures, according to the pharmaceutical, medical equipment management laws, regulations, rules, should be given administrative punishment, the Undertaker fill out the "Administrative Punishment for approval" (Schedule 20), the contractors responsible person audit opinion, reported drug supervision and administration department competent leadership for approval.
For major, complex administrative penalty cases should be decided by the drug regulatory departments of collective discussion and decision, and fill out the "collective discussion of major cases record" (Schedule 21).
Article 30 The drug regulatory authority which made the decision, it should be made "administrative punishment" (Schedule 22).
"administrative penalty decision" shall contain the following:
(a) the party's name or the name and address;
(two) violation of laws, rules or regulations of the facts and evidence;
(three) types of administrative penalties and basis;
(four) administrative penalties manner of and time limit;
(five) appeal an administrative penalty decision, apply for administrative reconsideration or bring an administrative lawsuit route and duration;
(six) make a decision on administrative punishment drug supervision and administration department name and date of the decision.
"administrative punishment" must be stamped with the decision of administrative punishment of drug supervision and administration department official seal.
administrative penalties contents confiscated counterfeit drugs, medical devices or related articles, "administrative penalty decision" shall be accompanied by "forfeiture certificate" (Schedule 23).
Article 31 The drug regulatory department of the confiscated drugs, medical equipment and related items and involved raw materials, packaging, counterfeiting equipment, shall exceed the proceedings after the deadline in accordance with the "Administrative Punishment Law" fiftieth three provisions to be addressed. It should be verified before processing variety, quantity and fill out the "forfeiture process for approval" (Schedule 24) and "confiscation Item Processing List" (Schedule 25).
Article 32 The drug regulatory departments in the investigation of cases when there are violations of the existing evidence, it shall issue "shall order a correction notice" (Schedule 26), ordered to make corrections within a time limit or illegal behavior. Section II Article 33 hearing procedures and drug administration departments ordered to cease making, revocation of license, revoke the pharmaceutical, medical device approval documents or large amounts of fines and other administrative punishment decision, it shall inform the parties to request a hearing rights.
party requests a hearing, the hearing should be organized.
larger amounts of fines for the designation, according to the province, autonomous regions and municipalities directly under the Standing Committee or the People's Government of the specific provisions.
Article 34 hearing shall follow an open and impartial manner. Except those involving state secrets, business parties, technical secrets or personal privacy, the hearing shall be conducted in public.
hearing implement informed avoidance system, and shall protect the rights and the statements of the parties the right to defend themselves.
Article 35 The drug regulatory authority for the administrative hearing procedures applicable penalty cases, it should be an administrative penalty decision, delivered to the parties' written notification of hearing "(Schedule 27).
"Hearing this book" should contain the following key issues:
(a) the name or names of the parties,2013 Football Boots Soccer Cleats ShoesNike Mercurial Vapor VIII TF 2012 White Blue ;
(two) parties illegal facts, the reasons for administrative penalties, basis and the administrative punishment decisions to be made;
(three) inform the parties have the right to request a hearing;
(four) inform the proposed hearings and hearings period required by the organ.
"Hearing this book" must be stamped with the official seal of the drug regulatory department.
Article 36 hearing, the parties informed in 3 days after receipt of a hearing request, drug supervision and administration department shall request a hearing the parties made within 3 days from the date of the hearing officer to determine the composition of the hearing time, place and manner and hold a hearing on the 7th, the "notice of hearing" (Schedule 28) served on the parties.
"hearing notice" should include the following items and affix the seal of the drug regulatory department:
(a) the name or names of the parties;
(two) hearing of the time, place and manner;
(three) the hearing officer's name;
(four) inform the parties of the right to apply for withdrawal;
(five) inform the parties to prepare evidence to inform witnesses and other matters.
Article 37 hearing, the party receiving the notice, shall attend the hearing, you can also entrust 1-2 people proxy to attend the hearing. Commissioned agency hearing shall be submitted by the parties signed or sealed power of attorney.
unable to attend the hearing as scheduled, it shall be informed in advance of the hearing presided Drug Administration. Justification not scheduled to participate in the hearing, as a waiver requests for hearings, drug supervision and management departments to be recorded in writing.
held during the hearing, the parties propose to exit a hearing, the drug regulatory authority may declare the hearing terminated and recorded transcripts of the hearing.
Article 38 hearing officer, including chairperson of the hearing and the court clerk.
chairperson of the hearing by a competent leadership Drug Administration designated the internal organs investigator of the case officers, the general rule of law by the authority or agency personnel officers engaged in legal work.
clerk by the drug regulatory department within an investigator of the case officers, responsible for the production of transcripts of the hearing and other matters.
Article 39 Any party chairperson of the hearing and the court clerk that interest in the case, the right to apply for withdrawal. The withdrawal by the chairperson of the hearing Drug Administration competent leadership decisions; clerk avoided by the chairperson of the hearing decision.
Article 40 of the following circumstances, the hearing shall be postponed:
(a) the parties have legitimate reasons are not present;
(two) parties grounds for recusal application, you need to redefine the hearing officer;
(three) need to summon new witnesses to the scene, or if there are new facts need to re-investigation and verification.
Article 41 hearing, the case investigators asked the parties illegal facts, evidence and recommended administrative penalty; party representation, defense and cross.
Article 42 hearing shall fill out the "transcripts of the hearing" (Schedule 29). "Transcripts of the hearing" shall contain the following:
(a) the cause of action;
(two) hearing participants name or title and address;
(three) chairperson, clerk name;
(four) hearing of the time, place, manner;
(five) cases contractors the facts, evidence and recommendation for administrative penalty;
(six) statements by the parties, defense and cross the contents;
(seven) hearing participants signed or sealed.
After the hearing, should be "transcripts of the hearing" on the spot to pay the parties and the case of contractors audited, correct signature or seal. Parties refused to sign, by the chairperson of the hearing in the "hearing record" indicated on.
Article 43 hearing, the chairperson of the hearing should be based on hearing the case, ask for a hearing opinions and fill out the "hearing submissions" (Schedule 30).
Article 44 hearing opinions and according to the provisions of Article 27 of the cases proposed collegial consensus, according to the procedure decision of administrative punishment; inconsistent submit collective leadership discussion and decision. The fact-finding is unclear, insufficient evidence, it should be re-investigation. Section Summary Article 45 illegal facts are clear, the evidence is conclusive, should be made according to the following administrative penalties, administrative punishment decisions can be made on the spot:
(a) warning;
(two) of citizens subject to a 50 yuan fine;
(three) for legal persons or other organizations impose a fine of 1,000 yuan.
Article 46 Drug law enforcement officers on the spot to make administrative punishment decision, the parties shall present their certificates to fill in a predetermined format, a numbered and stamped with the official seal of the drug regulatory department "on the spot administrative penalty decision" (Table 31).
"spot administrative penalty decision" shall set forth the parties violations, administrative penalties in accordance with (the applicable laws, regulations, rules, names and section, subsection, item, head), the content of specific penalties, time, place, refuses to accept the decision on administrative penalty may apply for administrative reconsideration or bring an administrative lawsuit paths, drug supervision and administration department name.
parties shall "on the spot administrative penalty decision" was signed or fingerprinted by law enforcement officers after the signing party on the spot.
parties refused to sign or press fingerprint, law enforcement officers should indicate the circumstances.
Article 47 Drug Administration for summary decision of administrative punishment, it should be in the "on the spot administrative penalty decision," and ordered the parties in writing or within a time limit to correct violations.
Article 48 Drug law enforcement officers on the spot to make administrative punishment decision, it should be reported within 7 working days after drug administration departments for the record belongs. Article 49 Section served "administrative penalty decision" shall be declared after the party on the spot by the parties in the "delivery receipt" (Schedule 32) was signed.
party is not present, it shall within seven days in accordance with the provisions of this section, the "administrative penalty decision" served on the parties.
"administrative punishment" served by the contractor to be punished units or individuals to sign, if the person indicated on the delivery receipt date of receipt and signed or sealed. Receipt date is the date of service.
served "administrative punishment" should be sent directly to the person to be served. If the person is a citizen, I am not, the cross-adult family member living sign; the person is a legal person or other organization should be decided by the legal representative, other person or organization primarily responsible for the legal person, other organization responsible for closing staff member to sign.
Article 50 of the person to be served or the adult family member living rejection "administrative punishment", and shall invite the person to be served or the units of grassroots organizations and explain the situation to the scene, in the administrative penalty decision delivery receipt and the date indicated on the reasons of the refusal by the person serving the witness signature (seal), the administrative penalty decision to stay in office to be punished units or individuals shall be deemed to be served.
51 served directly difficulties may entrust the nearest Drug Administration sent on behalf of or with "double registered" mail delivery, post office receipt shall indicate the date of receipt by the date of service.
State Drug Administration to revoke medicines, medical equipment approval documents, administrative penalties, to be punished by units of the province, autonomous regions and municipalities drug regulatory department served.
Article 52 missing person to be served, or other means in accordance with the provisions of undeliverable to notice to be served.
since the issue date of the announcement, at least 60 days shall be deemed to be served. Edit this section to perform closed Chapter VI Article 53 of "administrative punishment" after the service, the parties shall decide on the punishment of being performed within the time limit.
parties truly have financial difficulties and need to postpone or in installments to pay the fine, after the parties submit a written application, submit the relevant supporting materials. The case of contractor personnel collegial, compliance fill in the "extension (points) to pay fines of Approval Form" (Schedule 33), and by the decision of administrative punishment drug supervision and management departments competent leadership for approval. After approval of the competent leadership, filled by the parties extended (points) to pay fines of guarantee stating extension (sub) specific timing and amount of payment in the certificate signed and stamped, may suspend or installment payment fines.
Article 54 A party dissatisfied with the decision of administrative punishment, apply for administrative reconsideration or bring an administrative lawsuit, administrative penalty shall not be suspended, but for administrative reconsideration or administrative litigation, except during the ruling stop execution.
Article 55 to determine fines and confiscated drug supervision and management departments should be separated from the organ that collects the fines. Addition to the provisions confiscated on the spot fines, law enforcement officers shall collect fines.
Article 56 in accordance with the provisions of Article 45 of the administrative penalty decision made on the spot, one of the following circumstances, law enforcement officers to collect fines on the spot:
(a) shall be subject to a fine of 20 yuan;
(two) are not collected on the spot difficult to implement.
Article 57 in remote, water, inaccessible areas, drug regulatory authorities and law enforcement officers made the decision in accordance with these provisions, the parties to the designated bank to pay the fine is indeed difficult, put forward by the parties, the law enforcement Staff can collect fines on the spot.
Article 58 The drug regulatory departments and law enforcement officers confiscated on the spot fines to be issued to the parties provinces, autonomous regions and municipalities finance department unified system of fines receipt.
enforcement officers confiscated on the spot fines, shall collect fines within 2 days from the date of delivery to the drug regulatory department; drug supervision and administration department shall pay the fine within two days designated bank.
Article 59 the parties within the statutory period does not apply for administrative reconsideration or bring an administrative lawsuit, nor perform the administrative punishment decision, the drug regulatory department can customize the date of expiry of three months' time the people's court for enforcement .
drug supervision and management departments to apply to court for enforcement ago should fill out the "perform the administrative penalty decision summon book" (new Schedule 6), written summon the parties to fulfill their obligations, obligations to inform the duration and manner, plus a fine of standards, legally entitled to representation and defense rights. Plus a fine of the total amount does not exceed the original amount of the fine. Parties to make statements, defense, and drug supervision and administration department shall make a "statement plead record" (Schedule 19), recording the parties put forward the facts, reasons and evidence, and produced "stated defense review submissions," (new Schedule 7) . Parties raised the fact that the reasons or evidence is established, the drug regulatory department shall adopt.
"perform the administrative penalty decision summon book" served 10 days, the parties have not complied with the decision, the drug regulatory department may apply to court for enforcement, and fill out the "administrative penalties to enforce application" (Schedule 34 ).
Article 60 fulfill or perform administrative punishment decision, the contractor shall fill out the "Administrative Punishment Final Report" (Schedule 35), the relevant case material finishing Binding archived. Edit this paragraph Chapter VII Supplementary Provisions Article 61 The drug regulatory authority in violation of the provisions of its law enforcement officers to impose administrative penalties, in accordance with the "PRC Administrative Punishment Law", "Drug Administration Law," "People Republic of Drug Administration Law Implementing Regulations, "" Supervision and Regulation of Medical Devices, "the relevant provisions of the legal liability.
Article 62 of the Drug Enforcement Administration in accordance with the provisions of instruments from all over the demonstration format to produce their own schedule.
Article 63 The term drug supervision and management departments, is legally entitled to the right of administrative punishment and Drug Administration, the branch.
Article 64 These Regulations July 1, 2003 shall come into force. Since the effective date of this provision, the State Drug Administration in August 1, 1999 promulgated the "Administrative Punishment Drug Program" (State Drug Administration Decree No. 8) abolished.
Table 1-36 slightly, slightly new Schedule 1-7. [1]
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Ministry of Health decided to make modifications procedural requirements for administrative penalties Drug Chapter I Chapter II Chapter III jurisdiction investigation filed Chapter IV Chapter V Section General procedures penalty decision two Hearing Procedures Section IV served summarily executed and closed Chapter VI Chapter VII Supplementary Provisions expand Edit this paragraph Ministry of Health Order No. 88 of the "Ministry of Health on Amending The decision "was June 7, 2012 by the Ministry of Health, Ministry of Works Council, are hereby promulgated and the date of implementation. [1] Minister Chen Zhu, October 17, 2012 Edit this section to modify the Ministry of Health decided on revising the "Administrative Punishment Drug procedural requirements," the decision to implement the "Administrative Enforcement Law," according to the "State Council on the implementation of one of the first amended as follows: "To ensure the proper exercise of the drug regulatory department administrative penalty authority, protection of citizens, legal persons and other organizations of the legitimate rights and interests, according to the" PRC Administrative Punishment Law, "" People Republic of administrative enforcement, "" Drug Administration Law "," Drug Administration Law Implementing Regulations, "" Supervision and Regulation of Medical Devices "and the State Council administrative regulations, enactment of this provision."two, the third Paragraph 4 is amended as: "the implementation of administrative penalties, administrative enforcement and the principle of combining education."
three, Article 10, an increase of two, respectively, as the second and third paragraphs, namely: "The drugs, medical devices illegal cases suspected of a crime, drug supervision and administration department shall, within two working days of complete" refer the case for approval "(Schedule 1), the drug regulatory department head immediately after the approval of the leadership fill in the" suspected criminal cases transferred to the book "(new Schedule 1) transferred to the public security organs at the same level, with a copy to the same level People's Procuratorate and send a copy to the drug regulatory department superiors.
"decision to initiate the public security organs, the drug regulatory department shall, within three working days will be seized or detained goods handed over to the filing of the public security organs, and should fill out the" seizure (seizure) goods transferred Notice "( new Schedule 2), and inform the parties in writing. "
Four, Article 22 of the "" sequestration items for approval "(Schedule 9)", "" notice of seizure seizure of items "(Schedule 10)" were revised as follows: "'seizure (seizure) for approval "(Schedule 9)", "" seizure (seizure) decision "(Schedule 10)."
five, the first paragraph of Article 23 is amended as: "the drug regulatory departments to implement advanced registration and preservation or seizure, detention, it shall notify the parties present, and in the" site inspection record "in the taking of the relevant measures to be recorded case the parties are not the scene, law enforcement officers invited to witness the scene, the witnesses and law enforcement officers at the scene signed or sealed. "
six, the Article 24 is amended as: "the drug regulatory department of the cases that have been filed shall fill out the" notice filing "(Schedule 13), delivery of the parties.
"for advanced registration and preservation of the goods, it shall make a decision within seven days. pair seizure, seizure of goods, shall be filed within seven days after the decision is made whether; need to be inspected, the inspection report shall be issued from the date of 15 days to decide whether to file a case decision.
"seizure, detention period not exceeding 30 days; situation complicated, drug supervision and management departments should fill out the" seizure (seizure) Extension for approval "(new Schedule 3), the competent leadership Drug Administration approval can be extended, but the extension period shall not exceed 30 days; make extended seizure, detention period, the decision shall be promptly fill out the "seizure (seizure) Extension Notice" (new Schedule 4), inform the parties in writing and explain the reasons; right Items needed for testing, inspection or technical appraisal shall fill in "test (testing, technical appraisal) this book" (new Schedule 5), seizure, detention period does not include testing, inspection or technical appraisal period.
"filing does not meet the conditions, drug supervision and management departments should fill out the" register and keep goods lifting Notice "(Schedule 14), register and keep lifting, or fill in the" lift the seizure (seizure) decision "( Schedule 15), lift the seizure, seizure. "
seven, twenty-five will be amended as: "Drug law enforcement officers to investigate illegal facts, you need to identify the test sample shall be in accordance with the State Drug Administration departments to develop drugs or medical devices quality supervision and testing management provisions required sample. inspection agency shall promptly within the timeframe identified test. "
eight, Article 59 will be amended as follows: "The parties within the statutory time limit does not apply for administrative reconsideration or bring an administrative lawsuit, nor perform the administrative punishment decision, the drug regulatory department can customize the date of expiry of the three months' People's Court for enforcement.
"drug supervision and management departments to apply to court for enforcement ago should fill out the" perform the administrative penalty decision summon book "(new Schedule 6), written summon the parties to fulfill their obligations, obligations to inform the duration and manner, plus a fine of standards, shall enjoy the presentation and defense rights plus a fine of the total amount does not exceed the original amount of the fine the parties to make a statement, defense, and drug supervision and administration department shall make a "statement of defense transcripts" (Schedule 19), recording the parties propose facts, reasons and evidence, and produced "stated defense review submissions," (new Schedule 7) The parties put forward the facts, reasons or evidence is established, drug supervision and administration department shall adopt.
"" perform the administrative penalty decision summon book "served 10 days, the parties have not complied with the decision, the drug regulatory department may apply to court for enforcement, and fill out the" administrative penalties to enforce application "(Schedule 34). "
IX Schedule for the following modifications:
(a) by adding the following Schedule.
1. suspected criminal cases transferred to the book (new Schedule 1);
2. seizure (seizure) goods transferred notice (new Schedule 2);
3. seizure (seizure) Extension Approval Form (new Schedule 3);
4. seizure (seizure) extension notice (new Schedule 4);
5. inspection (testing, technical appraisal) Notification (new Schedule 5);
6. perform the administrative penalty decision summon books (new Schedule 6);
7. statement plead review submissions (new Schedule 7).
(two) to update the following table.
1. Schedule 9 "sequestration items for approval" is amended as: "seizure (seizure) for approval";
2. Schedule 10 "sequestration items notice" was changed to: "seizure (seizure) decision";
3. Schedule 13 "administrative processing notice" was changed to: "notice filing";
4. Schedule 15 "Unlock Items sequestration notice" was changed to: "lift the seizure (seizure) decision."
This decision shall enter into force from the date of publication. "Drug procedural requirements for administrative penalties," according to this decision be amended accordingly and re-released. [1] Edit this paragraph Drug procedural requirements for administrative penalties (April 28, 2003 Food and Drug Administration announced Decree No. 1, according to October 17, 2012 the Ministry of Health "on Amending decision "The Ministry of Health [88] Decree amended.) Edit this paragraph Chapter I General Provisions Article 1 In order to ensure proper exercise of the drug regulatory department administrative penalty authority, protection of citizens, legal persons and other organizations of the legitimate rights and interests, according to the" PRC Administrative Punishment Law, "" Administrative Enforcement Law "," Drug Administration Law "," Drug Administration Law Implementing Regulations, "" Supervision and Regulation of Medical Devices "and the State Council administrative regulations formulated regulations.
second violation of the drug regulatory department of medicines, medical equipment management laws, regulations, rules or individual units to impose administrative penalties, the application of this requirement.
Article Drug Administration to impose administrative penalties, must adhere to the following principles:
(a) the principles of statutory basis;
(two) the principle of legal procedures;
(three) fair and open manner;
(four) to impose administrative penalties, administrative enforcement and the principle of combining education;
(five) protection of citizens, legal persons and other organizations of the legitimate rights and interests principle.
Article IV drug regulatory departments shall establish administrative penalties supervision. Parent drug regulatory departments of pharmaceutical supervision and management departments to implement subordinate administrative penalties supervision. Parent drug regulatory departments of pharmaceutical supervision and management departments subordinate to the administrative penalty decision illegal, may be ordered to make corrections; overdue correction, the right to alter or rescind. [1] Edit this paragraph Chapter II Jurisdiction Article medicines, medical equipment supervision and management of administrative penalties by the offense took place in the drug regulatory department of jurisdiction.
above the county level drug regulatory department under the jurisdiction area of medicines, medical equipment administrative penalty cases.
provinces, autonomous regions and municipalities under the jurisdiction of the drug regulatory department within the jurisdiction of major and complex medicines, medical equipment administrative penalty cases.
jurisdiction of the State Drug Administration departments across the country have a significant impact of drugs, medical equipment administrative penalty cases.
provinces, autonomous regions and municipalities drug regulatory authority can be based on medicines, medical equipment management laws, regulations, rules and reality in the region to provide a specific level of jurisdiction within the jurisdiction of the division.
Article VII of two or more drug supervision and management departments of the disputed jurisdiction and report on a common drug regulatory department designated jurisdiction.
Article VIII Drug Administration found that cases do not belong to the department head or jurisdiction, it shall fill out the "case to approval" (Schedule 1), the drug regulatory department immediately after approval from the competent leadership fill out the "transfer of cases book "(Schedule 2), and the relevant case material shall be handed Drug Administration has jurisdiction over the department or the relevant administrative departments. Affected by the transfer of drug supervision and administration department shall be promptly communicated to the transfer case investigation results of cases the drug regulatory department.
affected by the transfer of drug supervision and administration department if deemed transferred improperly, shall be submitted on a common drug supervision and management departments designated jurisdiction, shall not be transferred again.
superiors after receiving the drug regulatory department under the jurisdiction of the dispute or report to the designated jurisdiction referrals shall, within 10 working days of the decision made by the designated jurisdiction.
Article IX subordinate Drug Administration within the jurisdiction of cases that should not be handled by the department, it may report the drug regulatory department under the jurisdiction or the designated jurisdiction. Parent drug regulatory department that subordinate Drug Administration should deal with cases within their jurisdiction, can decide their own jurisdiction or specify other subordinate Drug Administration jurisdiction.
Article drug regulatory department of the cases, we found that involving other drug regulatory department under the jurisdiction of the offense, should be completed with reference to the provisions of Article VIII of relevant instruments, together with the relevant evidence shall be handed over to the Drug Administration department. Has jurisdiction over the drug regulatory department of the transfer of the case shall be promptly investigated.
for drugs, medical devices illegal cases suspected of a crime, drug supervision and administration department shall, within two working days fill out the "case to approval" (Schedule 1), the drug regulatory authority approval of the competent leadership immediately after filling "suspected criminal cases transferred to the book" (new Schedule 1) transferred to the public security organs at the same level, with a copy to the same level People's Procuratorate and send a copy to the drug regulatory department superiors.
decision to initiate the public security organs, the drug regulatory department shall, within three working days will be seized or detained goods handed over to the filing of the public security organs, and should fill out the "seizure (seizure) goods transferred Notice" (New increase Schedule 2), and inform the parties in writing.
Article XI shall be revoked according to law "drug production license", "Drug License", "medical preparations license", "Medical Device Manufacturing Enterprise License", "Medical Device Distribution Enterprise License" , revoke the pharmaceutical, medical device approval documents, the original issuing Approved Drug Administration decision.
Drug Administration investigation of illegal cases, according to law shall be revoked "drug production license", "drug business license", "medical preparations license", "Medical Device Manufacturing Enterprise License", "Medical Device Distribution Enterprise License "revoke the pharmaceutical, medical device approval documents, within its mandate, to make administrative punishment according to the law at the same time, the evidence should be obtained and related materials submitted to the original issuance of the drug regulatory agency, the original issuing permit drug regulatory department shall decide whether or not revoke the license or revoke the approval documents of the administrative penalty decision.
required by the State Drug Administration revoked medicines, medical equipment approval documents, provinces, autonomous regions and municipalities drug regulatory department submitted to the State Drug Administration, the State Drug Administration department shall promptly make a decision .
original issuance of drug supervision and administration department shall revoke the license to make and revoke the approval documents of the administrative penalty decision must be based on the requirements.
drug supervision and administration department shall revoke that law "medical institution", and should be recommended for certification of health administrative authorities revoked.
Article XII belongs PLA units and individuals in violation of drug administration laws, regulations, rules of behavior, by the military Drug Administration based on "implementing the PLA Article XIV Drug Administration found violations of the following conditions shall be filed within seven working days:
(a) there is a clear violation suspects;
(two) there is objective illegal facts;
(three) belongs to the drug regulatory scope of administrative penalties;
(four) belonging to the jurisdiction of the department.
decide to initiate and should fill out the "Application Form for filing" (Schedule 4), reported department heads leadership instruction, approved the filing should identify two or more cases of drug supervision and law enforcement officers as contractors.
Article 15 of the following circumstances, the contractor for the case can not be determined by:
(a) is a party to the case or the parties are near relatives;
(two) with a direct interest in the case;
(three) parties have other relationships with the case, it may affect the impartial handling of the case. [1] Edit this paragraph Article XVI Chapter investigation conducted case investigation or inspection, the law enforcement officer shall not be less than two persons and shall provide the person being investigated or the relevant personnel present their certificates.
person being investigated or the officer shall truthfully answer questions and assist in the investigation or inspection, shall not obstruct.
involving state secrets, as well as the person being investigated business, technical secrets and personal privacy, the contractor shall keep a secret.
Article XVII between drug regulatory authorities investigate cases involving the situation, assist in the investigation mutual responsibility, the obligation to provide relevant evidence.
Article XVIII investigation by law enforcement officials, should fill out the "investigative records" (Table 5).
investigative records shall indicate the start of the identity of law enforcement personnel, document name, document number and investigation purposes. Law enforcement officers should be signed at the end of the investigation record.
investigative records is verified,Sale Nike Mercurial Glide III IC GS Black Fluorescent Green Soccer Cleats 2013 , after being investigated in the record shall be signed or fingerprinted by page, and in the record indicated on the transcript at the end of the authenticity of the comments. Transcripts modification office, shall be signed by the person being investigated or fingerprinted.
respondents refused to sign or press the fingerprints shall be conducted by two or more law enforcement officers to sign the transcript and indicate the circumstances.
Article XIX law enforcement officers carry out spot checks, it should fill the spot "site inspection record" (Table 6).
inspection record shall indicate the start of the identity of law enforcement personnel, document name, document number and inspection purposes. Law enforcement officers should be signed at the end of the inspection record.
inspection record is verified, after being checked in the record shall be signed or fingerprinted by page, and in the record indicated on the transcript at the end of the authenticity of the comments. Transcripts modification office, shall be signed by the person being checked or fingerprinted.
who refused to sign or be checked by fingerprints shall be conducted by two or more law enforcement officers to sign the transcript and indicate the circumstances.
Article XX Taking of evidence should be original, original. The transfer of the original, the original is really difficult, the evidence submitted by the entity or individual copies signed or stamped, and marked "with the original (object) the same," the words or text.
twenty-one who can show the true circumstances of the case documentary evidence, physical evidence, audiovisual materials, witness testimony, statements by the parties, inspection reports, conclusions, investigative records, transcripts and other on-site inspection for evidence of drug supervision and management of administrative punishment .
Article 22 evidence may be lost, or difficult to obtain in the case, law enforcement officers should fill out the "advanced registration and preservation items for approval" (Schedule 7), reported the competent leadership Drug Administration approval. Advanced registration and preservation items, law enforcement officers should be issued to the parties' advance notice of registration and preservation of goods "(Table 8).
drug supervision and management departments there is evidence that may harm human health pharmaceutical and related materials and the quality of medical devices have caused an accident or an accident may cause medical device quality products and relevant information, may be legally taken seizure, seizure of administrative enforcement measure. Law enforcement officers seized or detained goods before should fill out the "seizure (seizure) for approval" (Schedule 9), reported the competent leadership Drug Administration approval. Seizure, detention items, law enforcement officers should be issued to the parties' seizure (seizure) decision "(Schedule 10).
Twenty-three drug supervision and management departments to implement advanced registration and preservation or seizure, detention, it shall notify the parties present, and in the "site inspection record" in the case of measures, to be recorded. Parties do not scene, law enforcement officers invited to witness the scene, the witnesses and law enforcement officers at the scene signed or stamped.
seized or detained goods, you should use the official seal stamped with the department's "× × × Drug Administration seal" (Schedule 11), in situ or off-site storage items.
for advanced registration and preservation or seizure, the seized items should be listed in "() Items List" (Schedule 12), by law enforcement officers, signed by the parties or the officer or official seals.
parties refused to sign, seal, or received shall be conducted by two or more law enforcement officers on the list, signed and dated situation.
Twenty-four drug supervision and management departments should fill out a case has been filed "notice filing" (Schedule 13), delivery of the parties.
for advanced registration and preservation of goods, shall make a decision within seven days. For seized or detained goods, should be made within 7 days of the decision whether to file a case; need to be inspected, the inspection report shall be issued within 15 days from the date of making the decision whether to file a case.
seizure, detention period not exceeding 30 days; situation complicated, drug supervision and management departments should fill out the "seizure (seizure) Extension for approval" (new Schedule 3), the competent leadership Drug Administration approval, may be extended, but the extension period shall not exceed 30 days; make prolonged seizure, detention period, the decision shall be promptly fill out the "seizure (seizure) Extension Notice" (new Schedule 4), inform the parties in writing and explain the reasons; right items need for testing, inspection or technical appraisal should fill out the "inspection (testing, technical appraisal) this book" (new Schedule 5), seizure, detention period does not include testing, inspection or technical appraisal period.
filing does not meet the conditions, drug supervision and management departments should fill out the "register and keep goods lifting Notice" (Schedule 14), register and keep lifting, or fill in the "lift the seizure (seizure) decision" (attached Table 15), lift the seizure, seizure.
Article 25 Drug law enforcement officers to investigate illegal facts, you need to identify the test sample shall be according to the State Drug Administration departments to develop drugs or medical devices quality supervision and testing sample management requirements. Inspection agency shall promptly within the timeframe identified test.
Article 26 investigation has been concluded, the contractor shall write case end of the investigation reports. Its content should include the cause of action, the case, illegal facts, evidence handling procedures, in violation of laws, regulations or rules specific section, subsection, item, project, penalties proposed and signed by other contractors. (Except summary) [1] Edit this paragraph CHAPTER penalty decision procedure of Article 27 Section I General contractors submit cases end of the investigation report, the drug regulatory departments shall organize three or more violations of the relevant personnel facts, nature, circumstances, extent of social harm, handling procedures, etc. collegial, and fill out the "case collegiate record" (Schedule 16). Collegial should be based on identified illegal facts, in accordance with relevant medicines, medical equipment management laws, regulations and rules, respectively, deal with the views put forward the following:
(a) illegal facts are clear,Football Boots Soccer Cleats Shoes 2013 Limited Edition Nike Mercurial Vapor IX CR SE FG Fluorescent green pink , the evidence is conclusive, the program legal, administrative punishment according to law put forward opinions on there can not be punished, a lighter or mitigated punishment or aggravating circumstances presented no punishment, lighter or mitigated punishment or be punished severely opinion, constitutes a crime, an administrative penalty in the comments also suggested transferred to judicial organs be held criminally responsible;
(two) illegal facts are unclear, insufficient evidence, or the presence of bugs, and supplementary materials relevant evidence or re-investigation of the views;
(three) illegal facts can not be established, the proposed Withdrawn and fill out the "Withdrawn Application Form" (Schedule 17).
Article 28 The drug regulatory authority shall, before making the decision on punishment fill in the "Administrative Punishment ADVISED book" (Schedule 18), inform the parties of illegal facts, reasons and basis for punishment, and the parties are legally entitled to representation, defense rights.
drug supervision and management departments should fully listen to the statements of the parties and the defense and fill the spot "statement plead record" (Schedule 19), the parties presented the facts, reasons or evidence established by the review should be adopted.
drug supervision and administration department shall not impose heavier penalties on parties to defend themselves.
for hearing cases required by law, drug supervision and management departments to fulfill this obligation and the parties to exercise their prior statements, defense rights, in accordance with the provisions of Section II of this chapter.
Article 29 illegal facts are clear, the evidence is conclusive, legal procedures, according to the pharmaceutical, medical equipment management laws, regulations, rules, should be given administrative punishment, the Undertaker fill out the "Administrative Punishment for approval" (Schedule 20), the contractors responsible person audit opinion, reported drug supervision and administration department competent leadership for approval.
For major, complex administrative penalty cases should be decided by the drug regulatory departments of collective discussion and decision, and fill out the "collective discussion of major cases record" (Schedule 21).
Article 30 The drug regulatory authority which made the decision, it should be made "administrative punishment" (Schedule 22).
"administrative penalty decision" shall contain the following:
(a) the party's name or the name and address;
(two) violation of laws, rules or regulations of the facts and evidence;
(three) types of administrative penalties and basis;
(four) administrative penalties manner of and time limit;
(five) appeal an administrative penalty decision, apply for administrative reconsideration or bring an administrative lawsuit route and duration;
(six) make a decision on administrative punishment drug supervision and administration department name and date of the decision.
"administrative punishment" must be stamped with the decision of administrative punishment of drug supervision and administration department official seal.
administrative penalties contents confiscated counterfeit drugs, medical devices or related articles, "administrative penalty decision" shall be accompanied by "forfeiture certificate" (Schedule 23).
Article 31 The drug regulatory department of the confiscated drugs, medical equipment and related items and involved raw materials, packaging, counterfeiting equipment, shall exceed the proceedings after the deadline in accordance with the "Administrative Punishment Law" fiftieth three provisions to be addressed. It should be verified before processing variety, quantity and fill out the "forfeiture process for approval" (Schedule 24) and "confiscation Item Processing List" (Schedule 25).
Article 32 The drug regulatory departments in the investigation of cases when there are violations of the existing evidence, it shall issue "shall order a correction notice" (Schedule 26), ordered to make corrections within a time limit or illegal behavior. Section II Article 33 hearing procedures and drug administration departments ordered to cease making, revocation of license, revoke the pharmaceutical, medical device approval documents or large amounts of fines and other administrative punishment decision, it shall inform the parties to request a hearing rights.
party requests a hearing, the hearing should be organized.
larger amounts of fines for the designation, according to the province, autonomous regions and municipalities directly under the Standing Committee or the People's Government of the specific provisions.
Article 34 hearing shall follow an open and impartial manner. Except those involving state secrets, business parties, technical secrets or personal privacy, the hearing shall be conducted in public.
hearing implement informed avoidance system, and shall protect the rights and the statements of the parties the right to defend themselves.
Article 35 The drug regulatory authority for the administrative hearing procedures applicable penalty cases, it should be an administrative penalty decision, delivered to the parties' written notification of hearing "(Schedule 27).
"Hearing this book" should contain the following key issues:
(a) the name or names of the parties,2013 Football Boots Soccer Cleats ShoesNike Mercurial Vapor VIII TF 2012 White Blue ;
(two) parties illegal facts, the reasons for administrative penalties, basis and the administrative punishment decisions to be made;
(three) inform the parties have the right to request a hearing;
(four) inform the proposed hearings and hearings period required by the organ.
"Hearing this book" must be stamped with the official seal of the drug regulatory department.
Article 36 hearing, the parties informed in 3 days after receipt of a hearing request, drug supervision and administration department shall request a hearing the parties made within 3 days from the date of the hearing officer to determine the composition of the hearing time, place and manner and hold a hearing on the 7th, the "notice of hearing" (Schedule 28) served on the parties.
"hearing notice" should include the following items and affix the seal of the drug regulatory department:
(a) the name or names of the parties;
(two) hearing of the time, place and manner;
(three) the hearing officer's name;
(four) inform the parties of the right to apply for withdrawal;
(five) inform the parties to prepare evidence to inform witnesses and other matters.
Article 37 hearing, the party receiving the notice, shall attend the hearing, you can also entrust 1-2 people proxy to attend the hearing. Commissioned agency hearing shall be submitted by the parties signed or sealed power of attorney.
unable to attend the hearing as scheduled, it shall be informed in advance of the hearing presided Drug Administration. Justification not scheduled to participate in the hearing, as a waiver requests for hearings, drug supervision and management departments to be recorded in writing.
held during the hearing, the parties propose to exit a hearing, the drug regulatory authority may declare the hearing terminated and recorded transcripts of the hearing.
Article 38 hearing officer, including chairperson of the hearing and the court clerk.
chairperson of the hearing by a competent leadership Drug Administration designated the internal organs investigator of the case officers, the general rule of law by the authority or agency personnel officers engaged in legal work.
clerk by the drug regulatory department within an investigator of the case officers, responsible for the production of transcripts of the hearing and other matters.
Article 39 Any party chairperson of the hearing and the court clerk that interest in the case, the right to apply for withdrawal. The withdrawal by the chairperson of the hearing Drug Administration competent leadership decisions; clerk avoided by the chairperson of the hearing decision.
Article 40 of the following circumstances, the hearing shall be postponed:
(a) the parties have legitimate reasons are not present;
(two) parties grounds for recusal application, you need to redefine the hearing officer;
(three) need to summon new witnesses to the scene, or if there are new facts need to re-investigation and verification.
Article 41 hearing, the case investigators asked the parties illegal facts, evidence and recommended administrative penalty; party representation, defense and cross.
Article 42 hearing shall fill out the "transcripts of the hearing" (Schedule 29). "Transcripts of the hearing" shall contain the following:
(a) the cause of action;
(two) hearing participants name or title and address;
(three) chairperson, clerk name;
(four) hearing of the time, place, manner;
(five) cases contractors the facts, evidence and recommendation for administrative penalty;
(six) statements by the parties, defense and cross the contents;
(seven) hearing participants signed or sealed.
After the hearing, should be "transcripts of the hearing" on the spot to pay the parties and the case of contractors audited, correct signature or seal. Parties refused to sign, by the chairperson of the hearing in the "hearing record" indicated on.
Article 43 hearing, the chairperson of the hearing should be based on hearing the case, ask for a hearing opinions and fill out the "hearing submissions" (Schedule 30).
Article 44 hearing opinions and according to the provisions of Article 27 of the cases proposed collegial consensus, according to the procedure decision of administrative punishment; inconsistent submit collective leadership discussion and decision. The fact-finding is unclear, insufficient evidence, it should be re-investigation. Section Summary Article 45 illegal facts are clear, the evidence is conclusive, should be made according to the following administrative penalties, administrative punishment decisions can be made on the spot:
(a) warning;
(two) of citizens subject to a 50 yuan fine;
(three) for legal persons or other organizations impose a fine of 1,000 yuan.
Article 46 Drug law enforcement officers on the spot to make administrative punishment decision, the parties shall present their certificates to fill in a predetermined format, a numbered and stamped with the official seal of the drug regulatory department "on the spot administrative penalty decision" (Table 31).
"spot administrative penalty decision" shall set forth the parties violations, administrative penalties in accordance with (the applicable laws, regulations, rules, names and section, subsection, item, head), the content of specific penalties, time, place, refuses to accept the decision on administrative penalty may apply for administrative reconsideration or bring an administrative lawsuit paths, drug supervision and administration department name.
parties shall "on the spot administrative penalty decision" was signed or fingerprinted by law enforcement officers after the signing party on the spot.
parties refused to sign or press fingerprint, law enforcement officers should indicate the circumstances.
Article 47 Drug Administration for summary decision of administrative punishment, it should be in the "on the spot administrative penalty decision," and ordered the parties in writing or within a time limit to correct violations.
Article 48 Drug law enforcement officers on the spot to make administrative punishment decision, it should be reported within 7 working days after drug administration departments for the record belongs. Article 49 Section served "administrative penalty decision" shall be declared after the party on the spot by the parties in the "delivery receipt" (Schedule 32) was signed.
party is not present, it shall within seven days in accordance with the provisions of this section, the "administrative penalty decision" served on the parties.
"administrative punishment" served by the contractor to be punished units or individuals to sign, if the person indicated on the delivery receipt date of receipt and signed or sealed. Receipt date is the date of service.
served "administrative punishment" should be sent directly to the person to be served. If the person is a citizen, I am not, the cross-adult family member living sign; the person is a legal person or other organization should be decided by the legal representative, other person or organization primarily responsible for the legal person, other organization responsible for closing staff member to sign.
Article 50 of the person to be served or the adult family member living rejection "administrative punishment", and shall invite the person to be served or the units of grassroots organizations and explain the situation to the scene, in the administrative penalty decision delivery receipt and the date indicated on the reasons of the refusal by the person serving the witness signature (seal), the administrative penalty decision to stay in office to be punished units or individuals shall be deemed to be served.
51 served directly difficulties may entrust the nearest Drug Administration sent on behalf of or with "double registered" mail delivery, post office receipt shall indicate the date of receipt by the date of service.
State Drug Administration to revoke medicines, medical equipment approval documents, administrative penalties, to be punished by units of the province, autonomous regions and municipalities drug regulatory department served.
Article 52 missing person to be served, or other means in accordance with the provisions of undeliverable to notice to be served.
since the issue date of the announcement, at least 60 days shall be deemed to be served. Edit this section to perform closed Chapter VI Article 53 of "administrative punishment" after the service, the parties shall decide on the punishment of being performed within the time limit.
parties truly have financial difficulties and need to postpone or in installments to pay the fine, after the parties submit a written application, submit the relevant supporting materials. The case of contractor personnel collegial, compliance fill in the "extension (points) to pay fines of Approval Form" (Schedule 33), and by the decision of administrative punishment drug supervision and management departments competent leadership for approval. After approval of the competent leadership, filled by the parties extended (points) to pay fines of guarantee stating extension (sub) specific timing and amount of payment in the certificate signed and stamped, may suspend or installment payment fines.
Article 54 A party dissatisfied with the decision of administrative punishment, apply for administrative reconsideration or bring an administrative lawsuit, administrative penalty shall not be suspended, but for administrative reconsideration or administrative litigation, except during the ruling stop execution.
Article 55 to determine fines and confiscated drug supervision and management departments should be separated from the organ that collects the fines. Addition to the provisions confiscated on the spot fines, law enforcement officers shall collect fines.
Article 56 in accordance with the provisions of Article 45 of the administrative penalty decision made on the spot, one of the following circumstances, law enforcement officers to collect fines on the spot:
(a) shall be subject to a fine of 20 yuan;
(two) are not collected on the spot difficult to implement.
Article 57 in remote, water, inaccessible areas, drug regulatory authorities and law enforcement officers made the decision in accordance with these provisions, the parties to the designated bank to pay the fine is indeed difficult, put forward by the parties, the law enforcement Staff can collect fines on the spot.
Article 58 The drug regulatory departments and law enforcement officers confiscated on the spot fines to be issued to the parties provinces, autonomous regions and municipalities finance department unified system of fines receipt.
enforcement officers confiscated on the spot fines, shall collect fines within 2 days from the date of delivery to the drug regulatory department; drug supervision and administration department shall pay the fine within two days designated bank.
Article 59 the parties within the statutory period does not apply for administrative reconsideration or bring an administrative lawsuit, nor perform the administrative punishment decision, the drug regulatory department can customize the date of expiry of three months' time the people's court for enforcement .
drug supervision and management departments to apply to court for enforcement ago should fill out the "perform the administrative penalty decision summon book" (new Schedule 6), written summon the parties to fulfill their obligations, obligations to inform the duration and manner, plus a fine of standards, legally entitled to representation and defense rights. Plus a fine of the total amount does not exceed the original amount of the fine. Parties to make statements, defense, and drug supervision and administration department shall make a "statement plead record" (Schedule 19), recording the parties put forward the facts, reasons and evidence, and produced "stated defense review submissions," (new Schedule 7) . Parties raised the fact that the reasons or evidence is established, the drug regulatory department shall adopt.
"perform the administrative penalty decision summon book" served 10 days, the parties have not complied with the decision, the drug regulatory department may apply to court for enforcement, and fill out the "administrative penalties to enforce application" (Schedule 34 ).
Article 60 fulfill or perform administrative punishment decision, the contractor shall fill out the "Administrative Punishment Final Report" (Schedule 35), the relevant case material finishing Binding archived. Edit this paragraph Chapter VII Supplementary Provisions Article 61 The drug regulatory authority in violation of the provisions of its law enforcement officers to impose administrative penalties, in accordance with the "PRC Administrative Punishment Law", "Drug Administration Law," "People Republic of Drug Administration Law Implementing Regulations, "" Supervision and Regulation of Medical Devices, "the relevant provisions of the legal liability.
Article 62 of the Drug Enforcement Administration in accordance with the provisions of instruments from all over the demonstration format to produce their own schedule.
Article 63 The term drug supervision and management departments, is legally entitled to the right of administrative punishment and Drug Administration, the branch.
Article 64 These Regulations July 1, 2003 shall come into force. Since the effective date of this provision, the State Drug Administration in August 1, 1999 promulgated the "Administrative Punishment Drug Program" (State Drug Administration Decree No. 8) abolished.
Table 1-36 slightly, slightly new Schedule 1-7. [1]
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