Measures of the Chinese People's Liberation Army for Implementation of the Drug Administration Law of China

 2018-07-06  42


· Document Number:Decree No. 425 of the State Council and the Central Military Commission

· Area of Law: Military

· Level of Authority: Military Regulations

· Date issued:12-09-2004

· Effective Date:01-01-2005

· Status: Effective

· Issuing Authority: State Council Central Military Commission

 

Decree of the State Council of  China and the Central Military Commission of China
(No. 425)
The Measures of the Chinese People's Liberation Army for Implementation of the Drug Administration Law of the People's Republic of China is hereby promulgated, and it shall become effective from January 1, 2005.
Wen Jiabao, Premier of the State Council
Jiang Zemin, Chairman of the Central Military Commission
December 9, 2004
Measures of the Chinese People's Liberation Army for Implementation of the Drug Administration Law of the People's Republic of China
 Article 1 These Measures are formulated in accordance with the provisions of the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law) for the purpose of enhancing the supervision and administration of drugs in the armed forces.
 Article 2 The Health Department of the General Logistics Department of the Chinese People's Liberation Army (hereinafter referred to as the General Logistics Department) shall be responsible for the supervision and administration of drugs in the armed forces, while the drug regulatory department of the State Council shall perform the duty of supervision and administration in accordance with the provisions of these Measures.
Health sections of all general headquarters/departments, services and arms, and logistics (joint logistics) departments of military area commands shall be responsible for the supervision and administration of drugs in their sectors and units respectively.
 Article 3 Drug testing institutions of the Health Department of the General Logistics Department and of the joint logistics departments of military area commands (hereinafter referred to as the drug testing institutions in the armed forces) shall undertake the work of drug testing necessary for drug examination and approval and drug quality supervision and inspection conducted by the armed forces in accordance with the law.
 Article 4 Drug suppliers in the armed forces shall be responsible for ensuring the supply of drugs needed by medical institutions in the armed forces within the prescribed scope of supply.
Without the approval of the Health Department of the General Logistics Department, the health sections of services and arms or of the logistics (joint logistics) departments of military area commands, and the drug regulatory department of the State Council, no drug supplier in the armed forces may supply drugs to civilian drug distributors and medical institutions.
 Article 5 Drugs used by the armed forces for preventing and curing wartime injuries and diseases caused in a special military environment are military specially-needed drugs. The measures for development, examination and approval, dispensing and supply of military specially-needed drugs shall be separately formulated by the General Logistics Department.
 Article 6 Military specially-needed drugs shall be limited to internal use in the armed forces. Where a civilian medical institution needs to use these drugs under special circumstances, the matter shall be subject to verification and consent of the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government and approval of the Health Department of the General Logistics Department.
Where a military specially-needed drug needs to be converted into civilian use, the matter shall be subject to verification and consent of the Health Department of the General Logistics Department and shall be handled by the drug regulatory department of the State Council in accordance with the provisions of the Drug Administration Law.
 Article 7 The armed forces implement a system for the reserve of drugs for combat readiness.
Drug suppliers and medical institutions in the armed forces shall be responsible for reserve and renewal of drugs for combat readiness.
In case of an unexpected incident or other emergency, the reserve of drugs for combat readiness may be used upon approval by the General Logistics Department, services and arms or military area commands; when necessary, the General Logistics Department may consult with the relevant departments of the State Council to transfer drugs from the national reserve or from the enterprises for the urgent needs.
 Article 8 For purchasing drugs, drugs suppliers in the armed forces shall establish and apply a system for quality inspection and acceptance, and check the certificate of drug quality, labels and other marks; no drugs that do not meet the specified requirements may be purchased; those that meet the specified requirements shall be subject to quality testing conducted by the drug testing institutions in the armed forces according to the provisions of the Health Department of the General Logistics Department. Drug testing that drug testing institutions in the armed forces cannot undertake shall be entrusted to and conducted by drug testing institutions established or designated by the drug regulatory departments of the people's governments at or above the provincial level.
 Article 9 For purchasing drugs, medical institutions in the armed forces shall establish and apply a system for quality inspection and acceptance, and shall keep authentic and complete records on purchase of drugs. In the record shall be indicated the adopted name of the drug in China, dosage form, strength or size, batch number, date of expiry, manufacturer, supplier, amount of the drug purchased, purchase price, date of purchase, and other relevant items specified by the drug regulatory department of the State Council.
 Article 10 New drugs for civilian use researched and developed by research or medical institutions in the armed forces shall be subject to verification and consent by the Health Department of the General Logistics Department and approval by the drug regulatory department of the State Council.
 Article 11 Medical institutions in the armed forces to dispense pharmaceutical preparations shall satisfy the conditions specified by the drug regulatory department of the State Council. For those that satisfy the conditions for dispensing pharmaceutical preparations, the Health Department of the General Logistics Department or the health section of the joint logistics department of the military area command shall grant approval, and issue them the Pharmaceutical Preparations Certificate for Medical Institutions printed uniformly by the drug regulatory department of the State Council. No medical institutions in the armed forces may dispense pharmaceutical preparations without such certificates.
 Article 12 Pharmaceutical preparations to be dispensed by medical institutions in the armed forces shall be ones that are to meet the clinic need of the institutions but are not available on the market and shall be subject to approval by the Health Department of the General Logistics Department or the health section of the joint logistics department of the military area command, which shall issue a pharmaceutical preparations approval document. Where the varieties of pharmaceutical preparations to be dispensed need to be expanded based on military support operations, the matter shall be subject to approval by the Health Department of the General Logistics Department.
Pharmaceutical preparations dispensed by a medical institution in the armed forces shall be subject to quality testing according to the provisions; those passing the testing may be used within the institution on the basis of the physician's prescription. In special cases, such preparations may be used by other designated medical institutions in the armed forces upon approval by the Health Department of the General Logistics Department.
 Article 13 Where a civilian medical institution needs to use pharmaceutical preparations dispensed by a medical institution in the armed forces, the matter shall be subject to approval by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government.
Where a medical institution in the armed forces needs to use pharmaceutical preparations dispensed by a civilian medical institution, the matter shall be subject to approval by the Health Department of the General Logistics Department or the health section of the joint logistics department of the military area command. Where a civilian medical institution provides pharmaceutical preparations dispensed by itself for a medical institution in the armed forces, the matter shall be subject to approval by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government.
No pharmaceutical preparations dispensed by medical institutions in the armed forces may be marketed.
 Article 14 The measures for administration of pharmaceutical preparations dispensed in wartime by medical institutions in the armed forces shall be separately formulated by the General Logistics Department.
 Article 15 The Health Department of the General Logistics Department and the health section of the joint logistics department of the military area command shall conduct selective testing of drugs used in the armed forces according to the selective drug testing plans of the State and the armed forces; if drugs are included in the selective drug testing plan of the State, the results of selective testing shall be made public in the Drug Quality Announcement of the State.
 Article 16 Drug suppliers and medical institutions in the armed forces shall be kept informed, in a timely manner, of the quality, therapeutic efficacy and reactions of the drugs supplied or used by them. Serious adverse reactions possibly induced by drug use, if discovered, shall be dealt with according to the relevant provisions formulated by the drug regulatory department of the State Council jointly with the competent health department of the State Council.
 Article 17 The Health Department of the General Logistics Department or the health section of the joint logistics department of the military area command shall organize investigations of the pharmaceutical preparations having been dispensed by medical institutions in the armed forces upon approval; it shall withdraw the approval documents of the pharmaceutical preparations with uncertain therapeutic efficacy, serious adverse reaction, or other factors harmful to human health.
No pharmaceutical preparations the approval documents of which have been withdrawn maybe dispensed or used. Those already dispensed or used shall be destroyed or disposed of under the supervision of the Health Department of the General Logistics Department or the health sections of the general headquarters/departments, services and arms, or logistics (joint logistics)departments of military area commands concerned.
 Article 18 Using names or images of military units or personnel or using military equipment or installations in advertisements of drugs shall be strictly prohibited.
Advertising of military specially-needed drugs or pharmaceutical preparations dispensed by medical institutions in the armed forces shall be prohibited.
 Article 19 The Health Department of the General Logistics Department or the health sections of the general headquarters/departments, services and arms and logistics (joint logistics) departments of military area commands concerned may engage, as necessary, drug supervisors within the armed forces to assist the health departments in drug supervision and administration.
 Article 20 Where a medical institution in the armed forces uses counterfeit or substandard drugs, such drugs used shall be confiscated and the institution shall be ordered to make corrections; the principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Army; if a crime is constituted, criminal liability shall be investigated according to law.
 Article 21 Where a medical institution in the armed forces dispenses pharmaceutical preparations without obtaining the Pharmaceutical Preparations Certificate for Medical Institutions, the pharmaceutical preparations illegally dispensed shall be confiscated; the principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Anny; if a crime is constituted, criminal liability shall be investigated according to law.
 Article 22 Where a medical institution in the armed forces expands the varieties of pharmaceutical preparations dispensed by it without approval or dispenses counterfeit or substandard pharmaceutical preparations, it shall be ordered to stop dispensing the preparations, and shall have the illegally dispensed pharmaceutical preparations confiscated and the relevant approval documents of the pharmaceutical preparations withdrawn; if the circumstances are serious, the Pharmaceutical Preparations. Certificate for Medical Institutions shall be revoked; the principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Cedes of the Chinese People's Liberation Army; if a crime is constituted, criminal liability shall be investigated according to law.
 Article 23 Where a military unit provides conveniences such as transportation, keeping or storage of the drugs while it clearly knows or should clearly know that the drugs are counterfeit or substandard drugs, all the income therefrom shall be confiscated; the principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Army; if a crime is constituted, criminal liability shall be investigated according to law.
 Article 24 A drug supplier in the armed forces that supplies drugs for a civilian drug distributor or medical institution without approval shall be ordered to make corrections; the principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Army.
 Article 25 A medical institution in the armed forces that alters, sells, rents out or lends the Pharmaceutical Preparations Certificate for Medical Institutions or the approval document of pharmaceutical preparations shall be ordered to make corrections; the principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Army; if the circumstances are serious, the Pharmaceutical Preparations Certificate for Medical Institutions or the approval document of pharmaceutical preparations, if any, shall be revoked or withdrawn by the department that issues the certificate or document; if a crime is constituted, criminal liability shall be investigated according to law.
Other military units that falsify the Pharmaceutical Preparations Certificate for Medical Institutions shall be dealt with in accordance with the provisions of the preceding paragraph.
 Article 26 Where a medical institution in the armed forces conceals relevant facts or provides false information in applying for the Pharmaceutical Preparations Certificate for Medical Institutions or the approval document of pharmaceutical preparations, the relevant department shall not accept the application or grant approval, and shall give sanctions to its principal responsible persons, persons directly in charge and other persons directly responsible in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Army; the applicant shall not reapply for the Pharmaceutical Preparations Certificate for Medical Institutions or the same approval document of pharmaceutical preparations within one year.
 Article 27 Where a medical institution in the armed forces obtains the Pharmaceutical Preparations Certificate for Medical Institutions or the approval document of pharmaceutical preparations by fraud, bribing or other illegitimate means, the said certificate shall be revoked and the document shall be withdrawn; the principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Army; if a crime is constituted, criminal liability shall be investigated according to law; the applicant shall not reapply for the Pharmaceutical Preparations Certificate for Medical Institutions or the same approval document of pharmaceutical preparations within three years.
A civilian medical institution that uses without approval military specially-needed drags or pharmaceutical preparations dispensed by a medical institution in the armed forces shall be punished in accordance with the provisions of Article 80 of the Drug Administration law.
A civilian medical institution that provides without approval pharmaceutical preparations dispensed by it for a medical institution in the armed forces shall be punished in accordance with the provisions of Article 84 of the Drug Administration law.
 Article 28 Where a medical institution in the armed forces uses without approval pharmaceutical preparations dispensed by a civilian medical institution, it shall be ordered to make corrections and the pharmaceutical preparations illegally used shall be confiscated; its principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Army.
 Article 29 Where a medical institution in the armed forces sells its own dispensed pharmaceutical preparations on the market, it shall be ordered to make corrections, and the pharmaceutical preparations for illegal sale shall be confiscated; the principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Army; if the circumstances are serious, the Pharmaceutical Preparations Certificate for Medical Institutions shall be revoked by the department that issues the certificate.
 Article 30 Where a drug testing institution in the armed forces issues a false testing report, criminal liability shall be investigated in accordance with law if a crime is constituted; if no crime is constituted, the institution shall be ordered to make corrections and be given a warning; the principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Army; if the circumstances are serious, the institution shall be disqualified for testing in accordance with law; if the testing result issued by the institution is not true to fact and losses are thus caused, the institution shall bear corresponding liability of compensation for the losses.
 Article 31 Responsible persons, drug purchasers, physicians or other related persons of drug suppliers or medical institutions in the armed forces who accept money or things of value or other benefits offered by drug manufacturers, drug distributors or their agents shall be given sanctions in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Army; with regard to persons concerned that possess licenses, the departments that issue the licenses shall revoke their licenses if the circumstances are serious; if a crime is constituted, criminal liability shall be investigated in accordance with law.
 Article 32 Medical institutions or drug suppliers in the armed forces that violate the Drug Administration Law or these Measures and thus cause harm and losses to users of drugs shall bear the liability of compensation in accordance with law.
 Article 33 Military units or personnel that advertise drugs in violation of the provisions of these Measures shall be ordered to make corrections; the principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Cedes of the Chinese People's Liberation Army.
 Article 34 Where the health section of a military unit, in violation of the Drug Administration Law or these Measures, issues the Pharmaceutical Preparations Certificate for Medical Institutions to a medical institution in the armed forces that does not meet the specified requirements, or issues a drug approval document when the requirements for military specially-needed drugs are not met, the competent authority at the next higher level shall order it to make corrections; the principal responsible persons, the persons directly in charge and the other persons directly responsible shall be given sanctions in accordance with the provisions of the Disciplinary Codes of the Chinese People's Liberation Army; if a crime is constituted, criminal liability shall be investigated in accordance with law.
 Article 35 Unless otherwise specified in these Measures, penalties defined in these Measures shall be decided and enforced by the Health Department of the General Logistics Department or the health sections of the relevant general headquarters/departments, services and anus or logistics (joint logistics) departments of military area commands.
Upon finding violations of these Measures on the part of military units or personnel, the drug regulatory department of the State Council or of the people's government of the province, autonomous region or municipality directly under the Central Government shall notify the Health Department of the General Logistics Department or the health sections of the relevant general headquarters/departments, services and arms or logistics(joint logistics) departments of military area commands and may put forward suggestions for handling the case; the Health Department of the General Logistics Department or the health sections of the relevant general headquarters/departments, services and arms or logistics(joint logistics) departments of military area commands shall take immediate action to handle the case and notify the result of the action to the drug regulatory department of the State Council or of the people's government of the province, autonomous region or municipality directly under the Central Government.
 Article 36 Measures for the armed forces to purchase and supply drugs under the State special control shall be implemented in accordance with the relevant previsions of the State.
 Article 37 Drug supervision and administration in the Chinese People's Armed Police Force shall be executed with reference to these Measures.
 Article 38 These Measures shall be effective as of January 1, 2005.