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中華人民共和國(guó)藥品管理法
LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON THE ADMINISTRATION OF DRUGS
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中華人民共和國(guó)藥品管理法
LAW OF THE PEOPLE'S REPUBLIC OF CHINA ON THE ADMINISTRATION OF DRUGS
第一條為加強(qiáng)藥品監(jiān)督管理，保證藥品質(zhì)量，增進(jìn)藥品療效，保障人民用藥安全，維護(hù)人民身體健康，特制定本法。
[Article 1] This law has been drawn up in order to strengthen drug control and
administration, ensure the quality of drugs, enhance the efficacy of drugs,
guarantee safe drug use and safeguard the physical health of the people.
第二條國(guó)務(wù)院衛(wèi)生行政部門主管全國(guó)藥品監(jiān)督管理工作。
[Article 2] The State Council department responsible for health administration
is the body in charge of national drug control and administration.
第三條國(guó)家發(fā)展現(xiàn)代藥和傳統(tǒng)藥，充分發(fā)揮其在預(yù)防、醫(yī)療和保健中的作用。
[Article 3] The State develops both modern medicines and traditional
medicines, and fully utilises them in the prevention and treatment of disease,
as well as in health care.
國(guó)家保護(hù)野生藥材資源 鼓勵(lì)培育中藥材。
The State safeguards resources of uncultivated medicinal materials and
encourages the cultivation of raw materials used for traditional Chinese
medicines.
第二章藥品生產(chǎn)企業(yè)的管理
CHAPTER II ADMINISTRATION OF DRUG-PRODUCING ENTERPRISES
第四條開辦藥品生產(chǎn)企業(yè)必須由所在省、自治區(qū)、直轄市藥品生產(chǎn)經(jīng)營(yíng)主管部門審查同意，經(jīng)所在省、自治區(qū)、直轄市衛(wèi)生行政部門審核批準(zhǔn)，并發(fā)給《藥品生產(chǎn)企業(yè)許可證》。
[Article 4] The establishment of a drug-producing enterprise must be examined
and agreed to by the department in charge of drug production and handling in the
province, autonomous region or municipality under the direct control of the
Central Government in which the enterprise is located. It shall be subject to
examination and approval by the department responsible for health administration
in the province, autonomous region or municipality under the direct control of
the Central Government, which shall issue the "Drug-production Enterprise
Licence".
無《藥品生產(chǎn)企業(yè)許可證》的工商行政管理部門不得發(fā)給《營(yíng)業(yè)執(zhí)照》。
Without a "Drug-production Enterprise Licence", the department administering
industry and commerce may not issue a "Business Licence".
《藥品生產(chǎn)企業(yè)許可證》應(yīng)當(dāng)規(guī)定有效期，到期重新審查發(fā)證。具體辦法由國(guó)務(wù)院衛(wèi)生行政部門規(guī)定。
The "Drug-production Enterprise Licence" shall stipulate its period of
validity, and at the expiry of the period the issue of the licence shall be
examined afresh. Specific procedures will be determined by the State Council
department responsible for health administration.
第五條開辦藥品生產(chǎn)企業(yè)必須具備以下條件：
[Article 5] The establishment of an enterprise to produce drugs must satisfy
the following conditions:
?。ㄒ唬┚哂信c所生產(chǎn)藥品相適應(yīng)的藥師或者助理工程師以上技術(shù)人員及技術(shù)工人。
(1) It must employ pharmacists, technical personnel above the rank of
assistant engineer and technical workers appropriate to the drug production
carried out by the enterprise.
中藥飲片加工企業(yè)沒有藥師或者助理工程師以上技術(shù)人員，配備熟悉藥性并經(jīng)縣級(jí)以上衛(wèi)生行政部門審查登記的藥工人員。
Where an enterprise engaged in the processing of traditional Chinese medicine
does not have a pharmacist or technical personnel of a rank above that of
assistant engineer, it may use drug industry personnel with an intimate
knowledge of drugs who have been examined and registered by a department of
health administration above the county level.
?。ǘ┚哂信c所生產(chǎn)藥品相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境。
(2) It must have a factory building, facilities and a hygienic environment
appropriate to its production of drugs.
?。ㄈ┚哂心軐?duì)所生產(chǎn)藥品進(jìn)行質(zhì)量檢驗(yàn)的機(jī)構(gòu)或者人員以及必要的儀器設(shè)備。
(3) It must have an organisation or personnel capable of carrying out quality
examinations on the drugs produced as well as the necessary instruments and
equipment.
第六條藥品必須按照工藝規(guī)程進(jìn)行生產(chǎn)，生產(chǎn)記錄必須完整準(zhǔn)確。
[Article 6] The production of drugs must be carried out in accordance with the
correct technological procedures; production records shall be kept in detail and
accurately.
中藥飲片的炮制必須符合《中華人民共和國(guó)藥典》,或者省、自治區(qū)、直轄市衛(wèi)生行政部門制定的《炮制規(guī)范》的規(guī)定。
The preparation of Chinese medicines shall be in accordance with the
"Pharmacopoeia of the People's Republic of China", or in accordance with the
"Preparation Standards" laid down by the department administering health in that
province, autonomous region or municipality under the direct control of the
Central Government.
第七條生產(chǎn)藥品所需的原料、輔料以及直接接觸藥品的容器和包裝材料，必須符合藥用要求。
[Article 7] Raw materials and supplementary materials required for the
production of drugs as well as containers and packing materials which come into
direct contact with drugs shall meet standards required for pharmaceutical use.
第八條藥品出廠前必須經(jīng)過質(zhì)量檢驗(yàn)；不符合標(biāo)準(zhǔn)的，不得出廠。
[Article 8] Before drugs leave the factory, they must pass a quality
examination. If they do not reach the required standard, they must not leave the
factory.
第九條藥品生產(chǎn)企業(yè)必須按照國(guó)務(wù)院衛(wèi)生行政部門制定的《藥品生產(chǎn)質(zhì)量管理規(guī)范》的要求，制定和執(zhí)行保證藥品質(zhì)量的規(guī)章制度和衛(wèi)生要求。
[Article 9] Drug-producing enterprises must formulate and implement a system
of rules and regulations and hygiene requirements to guarantee the quality of
drugs in accordance with the requirements of the "Standards for the
Administration of Drug-production Quality" laid down by the department of the
State Council administering health.
第三章藥品經(jīng)營(yíng)企業(yè)的管理
CHAPTER III ADMINISTRATION OF DRUG-HANDLING ENTERPRISES
第十條開辦藥品經(jīng)營(yíng)企業(yè)必須由所在地藥品生產(chǎn)經(jīng)營(yíng)主管部門審查同意，經(jīng)縣級(jí)以上衛(wèi)生行政部門審核批準(zhǔn)，并發(fā)給《藥品經(jīng)營(yíng)企業(yè)許可證》。無《藥品經(jīng)營(yíng)企業(yè)許可證》的，工商行政管理部門不得發(fā)給《營(yíng)業(yè)執(zhí)照》。
[Article 10] The establishment of a drug-handling enterprise must be examined
and agreed to by the department responsible for drug production and handling in
the place where the enterprise is situated, and must be examined and approved by
a health department at county level or above, which will issue a "Drug-handling
Enterprise Licence", without which the department administering industry and
commerce may not issue a "Business Licence".
《藥品經(jīng)營(yíng)企業(yè)許可證》應(yīng)當(dāng)規(guī)定有效期，到期重新審查發(fā)證。具體辦法由國(guó)務(wù)院衛(wèi)生行政部門規(guī)定。
A "Drug-handling Enterprise Licence" shall stipulate its period of validity,
and at the expiry of the period the issue of the licence shall be examined
afresh. Specific procedures will be determined by the department of the State
Council administering health.
第十一條開辦藥品經(jīng)營(yíng)企業(yè)必須具備以下條件：
[Article 11] The establishment of a drug-handling enterprise must satisfy the
following conditions:
?。ㄒ唬┚哂信c所經(jīng)營(yíng)藥品相適應(yīng)的藥學(xué)技術(shù)人員。
(1) It must employ pharmaceutical technicians appropriate to the medicines
handled.
經(jīng)營(yíng)中藥的企業(yè)和兼營(yíng)藥品的企業(yè)沒有藥學(xué)技術(shù)人員.配備熟悉所經(jīng)營(yíng)藥品的藥性并經(jīng)縣級(jí)以上衛(wèi)生行政部門審查登記的藥工人員。
Where an enterprise engaged in the handling of Chinese medicines or partly
engaged in handling drugs does not have a pharmaceutical technician it may use
drug industry personnel with an intimate knowledge of the medicinal nature of
the drugs handled who have been examined and registered by a department
administering health at above county level.
?。ǘ┚哂信c所經(jīng)營(yíng)藥品相適應(yīng)的營(yíng)業(yè)場(chǎng)所、設(shè)備、倉(cāng)儲(chǔ)設(shè)施和衛(wèi)生環(huán)境。
(2) It must have business premises, equipment, storage facilities and a
hygienic environment appropriate to the drugs handled.
第十二條收購(gòu)藥品，必須進(jìn)行質(zhì)量驗(yàn)收；不合格的，不得收購(gòu)。
[Article 12] On purchasing drugs, quality examinations must be carried out; if
the drugs do not come up to standard, they may not be purchased.
第十三條銷售藥品必須準(zhǔn)確無誤，并正確說明用法、用量和注意事項(xiàng)；
[Article 13] In selling drugs, it is necessary to be exact and accurate; the
method of use, dosage and points to note must be explained precisely.
調(diào)配處方必須經(jīng)過核對(duì)，對(duì)處方所列藥品不得擅自更改或者代用。
In making up prescriptions, checks must be carried out; the drugs itemised in
the prescription must not be altered or substituted without authorisation.
對(duì)有配伍禁忌或者超劑量的處方應(yīng)當(dāng)拒絕調(diào)配；必要時(shí)經(jīng)處方醫(yī)生更正或者重新簽字，方可調(diào)配。
Where a prescription contains ingredients that are incompatible or amounts of
ingredients in excess of the proper dosage, a request to make up the
prescription shall be refused; if necessary, after the prescribing doctor has
corrected it and signed it again, it may be made up.
銷售地道中藥材，必須標(biāo)明產(chǎn)地。
Where authentic Chinese medicines are sold, they shall be labelled to indicate
the place of origin.
第十四條藥品倉(cāng)庫(kù)必須制定和執(zhí)行藥品保管制度，采取必要的冷藏、防潮、防蟲、防鼠等措施。
[Article 14] Drug warehouses shall lay down and implement a system of rules
and regulations for the storage of drugs and take measures necessary in relation
to cold storage, protection against damp, and protection from insects, rodents,
etc.
藥品入庫(kù)出庫(kù)必須執(zhí)行檢查制度。
An inspection system shall be put into effect in relation to drugs which are
brought into or removed from the warehouse.
第十五條城鄉(xiāng)集市貿(mào)易市場(chǎng)可以出售中藥材，國(guó)家另有規(guī)定的除外。
[Article 15] Chinese medicinal materials may be sold in town and country
trading markets except where otherwise stipulated by the State.
城鄉(xiāng)集市貿(mào)易市場(chǎng)不得出售中藥材以外的藥品持有《藥品經(jīng)營(yíng)企業(yè)許可證》的除外。
Drugs other than Chinese medicinal materials may not be sold in the trading
markets of country towns, unless a "Drug-handling Enterprise Licence" is held.
第四章醫(yī)療單位的藥劑管理
CHAPTER IV ADMINISTRATION OF DRUGS IN MEDICAL TREATMENT UNITS
第十六條醫(yī)療單位必須配備與其醫(yī)療任務(wù)相適應(yīng)的藥學(xué)技術(shù)人員，非藥學(xué)技術(shù)人員不得直接從事藥劑技術(shù)工作。
[Article 16] Medical treatment units must be staffed with the number of
pharmaceutical technicians appropriate to their medical treatment
responsibilities. Personnel who are not pharmaceutical technicians may not be
engaged directly in pharmaceutical technical work.
第十七條醫(yī)療單位配制制劑必須經(jīng)所在省、自治區(qū)、直轄市衛(wèi)生行政部門審查批準(zhǔn)，并發(fā)給《制劑許可證》。
[Article 17] The making up of drugs by medical treatment units must be
examined and approved by the department in charge of health administration in
the province, autonomous region or municipality under the direct control of the
Central Government where the unit is situated, which will issue a "Dispensing
Licence".
《制劑許可證》應(yīng)當(dāng)規(guī)定有效期，到期重新審查發(fā)證。具體辦法由國(guó)務(wù)院衛(wèi)生行政部門規(guī)定。
A "Dispensing Licence" shall stipulate its period of validity, and at the
expiry of the period the issue of the licence shall be examined afresh. Specific
procedures will be laid down by the department of the State Council
administering health.
第十八條醫(yī)療單位配制制劑必須具有能夠保證制劑質(zhì)量的設(shè)施、檢驗(yàn)儀器和衛(wèi)生條件。
[Article 18] A medical treatment unit which makes up drugs must have adequate
facilities, instruments for examination and hygienic conditions to ensure the
quality of the drugs prepared.
第十九條醫(yī)療單位配制的制劑，必須根據(jù)臨床需要并按照規(guī)定進(jìn)行質(zhì)量檢驗(yàn)；合格的，憑醫(yī)生處方使用。
[Article 19] The drugs made up by medical treatment units must comply with
clinical requirements and, in accordance with regulations, quality examinations
must be conducted. They are only to be used if up to quality and on a doctor's
prescription.
醫(yī)療單位配制的制劑不得在市場(chǎng)銷售。
Drugs made up by medical treatment units may not be sold on the market.
第二十條醫(yī)療單位購(gòu)進(jìn)藥品，必須執(zhí)行質(zhì)量驗(yàn)收制度。
[Article 20] When a medical treatment unit purchases drugs, it must implement
a system of checking the quality on delivery.
第五章藥品的管理
CHAPTER V DRUG ADMINISTRATION
第二十一條國(guó)家鼓勵(lì)研究、創(chuàng)制新藥。
[Article 21] The State encourages research into and development of new drugs.
研制新藥必須按照規(guī)定向國(guó)務(wù)院衛(wèi)生行政部門或者省、自治區(qū)、直轄市衛(wèi)生行政部門報(bào)送研制方法、質(zhì)量指標(biāo)、藥理及毒理試驗(yàn)結(jié)果等有關(guān)資料和樣品。經(jīng)批準(zhǔn)后，方可進(jìn)行臨床試驗(yàn)或者臨床驗(yàn)證。
Where a new drug has been researched and developed, in accordance with the
regulations, a report must be submitted, with samples, to the State Council
department administering health or the department of the province, autonomous
region or municipality under the direct control of the Central Government
administering health, giving details of the method of research and development,
quality norms, pharmacological and toxicological tests and other relevant data.
Only after it has been approved may clinical tests or clinical verifications be
carried out.
完成臨床試驗(yàn)或者臨床驗(yàn)證并通過鑒定的新藥由國(guó)務(wù)院衛(wèi)生行政部門批準(zhǔn)發(fā)給證書。
Where a new drug has completed its clinical tests or clinical verification and
has passed an appraisal it may be approved by the department of the State
Council administering health, which will issue a certificate.
第二十二條生產(chǎn)新藥，必須經(jīng)國(guó)務(wù)院衛(wèi)生行政部門批準(zhǔn)，并發(fā)給批準(zhǔn)文號(hào)。但是，生產(chǎn)中藥飲片除外。
[Article 22] The production of new drugs must be approved by the department of
the State Council administering health which will issue an approval number.
However, the production of Chinese medicines sliced and prepared for decoction
is excepted.
生產(chǎn)已有國(guó)家標(biāo)準(zhǔn)或者省、自治區(qū)、直轄市標(biāo)準(zhǔn)的藥品，必須經(jīng)省、自治區(qū)、直轄市衛(wèi)生行政部門征求同級(jí)藥品生產(chǎn)經(jīng)營(yíng)主管部門意見后審核批準(zhǔn)，并發(fā)給批準(zhǔn)文號(hào)。但是，生產(chǎn)中藥飲片除外。
The production of drugs for which there is already a national drug standard,
or a drug standard of a province, autonomous region or municipality under the
direct control of the Central Government, must be examined and approved by the
department responsible for health administration in the relevant province,
autonomous region or municipality under the direct control of the Central
Government after seeking the opinion of the corresponding authority responsible
for the drug-producing enterprise. An approval number will be issued. However,
the production of Chinese medicines sliced and prepared for decoction is
excepted.
第二十三條藥品必須符合國(guó)家藥品標(biāo)準(zhǔn)或者省、自治區(qū)、直轄市藥品標(biāo)準(zhǔn)。
[Article 23] Drugs must comply with the national drug standard, or with the
drug standard of the province, autonomous region or municipality under the
direct control of the Central Government.
國(guó)務(wù)院衛(wèi)生行政部門頒布的《中華人民共和國(guó)藥典》和藥品標(biāo)準(zhǔn)，為國(guó)家藥品標(biāo)準(zhǔn)。
The "Pharmacopoeia of the People's Republic of China" and drug standards
promulgated by the department of the State Council administering health are the
national drug standards.
國(guó)務(wù)院衛(wèi)生行政部門的藥典委員會(huì)負(fù)責(zé)組織國(guó)家藥品標(biāo)準(zhǔn)的制定和修訂。
The Pharmacopoeia Committee of the department of the State Council
administering health is the body responsible for handling the setting and
revision of national drug standards.
第二十四條國(guó)務(wù)院衛(wèi)生行政部門和省、自治區(qū)、直轄市衛(wèi)生行政部門可以成立藥品審評(píng)委員會(huì)，對(duì)新藥進(jìn)行審評(píng)，對(duì)已經(jīng)生產(chǎn)的藥品進(jìn)行再評(píng)價(jià)。
[Article 24] The State Council department responsible for health
administration and the departments of the provinces, autonomous regions and
municipalities under the direct control of the Central Government administering
health may establish a Drug Evaluation Committee to evaluate new drugs and
re-evaluate drugs already being produced.
第二十五條國(guó)務(wù)院衛(wèi)生行政部門對(duì)已經(jīng)批準(zhǔn)生產(chǎn)的藥品，應(yīng)當(dāng)組織調(diào)查；對(duì)療效不確、不良反應(yīng)大或者其他原因危害人民健康的藥品，應(yīng)當(dāng)撤銷其批準(zhǔn)文號(hào)。
[Article 25] The department of the State Council responsible for administering
health shall organise investigation into drugs already approved for production;
where the efficacy of a drug is not reliable, the side-effects to a drug are
great, or a drug is for any other reason harmful to people's health, the
approval number shall be revoked.
已被撤銷批準(zhǔn)文號(hào)的藥品不得繼續(xù)生產(chǎn)、銷售；已經(jīng)生產(chǎn)的由當(dāng)?shù)匦l(wèi)生行政部門監(jiān)督銷毀或者處理。
Where the approval number of a drug has been revoked, production and sale of
the drug may not be continued; what has already been produced shall be burnt or
disposed of under the supervision of the local department administering health.
第二十六條禁止進(jìn)口療效不確、不良反應(yīng)大或者其他原因危害人民健康的藥品。
[Article 26] It is forbidden to import a drug if its efficacy is not reliable,
if its side-effects are great, or it is for any other reason harmful to people's
health.
第二十七條首次進(jìn)口的藥品，進(jìn)口單位必須提供該藥品的說明書、質(zhì)量標(biāo)準(zhǔn)、檢驗(yàn)方法等有關(guān)資料和樣品以及出口國(guó)（地區(qū)）批準(zhǔn)生產(chǎn)的證明文件，經(jīng)國(guó)務(wù)院衛(wèi)生行政部門批準(zhǔn)，方可簽訂進(jìn)口合同。
[Article 27] Where a drug is being imported for the first time, the importing
unit must submit a written description of the drug, details of its quality
standards, testing and other relevant data, samples, and documentation proving
that the exporting country (place) has approved production. Only when the
approval of the department of the State Council administering health has been
obtained may the import contract be signed.
第二十八條進(jìn)口的藥品，必須經(jīng)國(guó)務(wù)院衛(wèi)生行政部門授權(quán)的藥品檢驗(yàn)機(jī)構(gòu)檢驗(yàn)；檢驗(yàn)合格的，方準(zhǔn)進(jìn)口。
[Article 28] Imported drugs must be examined by a drug examination body so
authorised by the State Council department responsible for health
administration. Only when a drug passes examination will importation be
permitted.
醫(yī)療單位臨床急需或者個(gè)人自用進(jìn)口的少量藥品按照海關(guān)的規(guī)定辦理進(jìn)口手續(xù)。
The importation of a small amount of a drug to meet the urgent clinical needs
of a medical treatment unit or for the personal use of an individual is to
follow the importation procedures stipulated by Customs.
第二十九條對(duì)國(guó)內(nèi)供應(yīng)不足的中藥材、中成藥，國(guó)務(wù)院衛(wèi)生行政部門有權(quán)限制或者禁止出口。
[Article 29] Where the supply of Chinese medicinal materials or prepared
Chinese medicine is not sufficient for the Chinese domestic market, the State
Council department responsible for health administration has the power to
restrict or prohibit its export.
第三十條進(jìn)口、出口麻醉藥品和國(guó)務(wù)院衛(wèi)生行政部門規(guī)定范圍內(nèi)的精神藥品，必須持有國(guó)務(wù)院衛(wèi)生行政部門發(fā)給的《進(jìn)口準(zhǔn)許證》、《出口準(zhǔn)許證》。
[Article 30] In order to import or export narcotic drugs or psychotropic drugs
which come within the scope laid down by the department of the State Council
administering health, it is necessary to hold an "Import Licence" or "Export
Licence" issued by the department of the State Council administering health.
第三十一條新發(fā)現(xiàn)和從國(guó)外引種的藥材，經(jīng)省、自治區(qū)、直轄市衛(wèi)生行政部門審核批準(zhǔn)后，方可銷售。
[Article 31] Medicinal materials which have been newly discovered or
introduced from abroad may only be sold where they have been examined and
approved by the department of the province, autonomous region or municipality
under the direct control of the Central Government administering health.
第三十二條地區(qū)性民間習(xí)用藥材的具體管理辦法，由國(guó)務(wù)院衛(wèi)生行政部門制定。
[Article 32] Detailed provisions for the administration of local customarily
used folk medicines will be laid down by the State Council department
responsible for health administration.
第三十三條禁止生產(chǎn)、銷售假藥。有下列情形之一的為假藥：
[Article 33] The production and sale of spurious drugs is prohibited. A drug
is spurious if any one of the following circumstances exists:
?。ㄒ唬┧幤匪煞莸拿Q與國(guó)家藥品標(biāo)準(zhǔn)或者省、自治區(qū)、直轄市藥品標(biāo)準(zhǔn)規(guī)定不符合的；
(1) The names of the ingredients contained in the drug do not correspond to
the national drug standard or the drug standard set by the province, autonomous
region or municipality under the direct control of the Central Government;
?。ǘ┮苑撬幤访俺渌幤坊蛘咭运N藥品冒充此種藥品
(2) A substance that is not a drug is passed off as a drug, or one sort of
drug is passed off as another drug.
有下列情形之一，藥品按假藥處理：
A drug will be treated as a spurious drug if one of the following
circumstances exists:
?。ㄒ唬﹪?guó)務(wù)院衛(wèi)生行政部門規(guī)定禁止使用的；
(1) The State Council department responsible for health administration has
stipulated that its use is forbidden;
?。ǘ┪慈〉门鷾?zhǔn)文號(hào)生產(chǎn)的；
(2) It was produced without first obtaining an approval number;
?。ㄈ┳冑|(zhì)不能藥用的；
(3) Due to deterioration, it cannot be used for medicinal purposes;
（四）被污染不能藥用的。
(4) Due to contamination, it cannot be used for medicinal purposes.
第三十四條禁止生產(chǎn)、銷售劣藥。有下列情形之一的藥品為劣藥：
[Article 34] It is forbidden to produce or sell inferior drugs. A drug is
inferior if one of the following circumstances exists:
?。ㄒ唬┧幤烦煞莸暮颗c國(guó)家藥品標(biāo)準(zhǔn)或者省、自治區(qū)、直轄市藥品標(biāo)準(zhǔn)規(guī)定不符合的；
(1) The content of its ingredients does not comply with the national drug
standard or the drug standard set by the province, autonomous region or
municipality under the direct control of the Central Government;
?。ǘ┏^有效期的；
(2) Its period of efficacy has expired;
（三）其他不符合藥品標(biāo)準(zhǔn)規(guī)定的。
(3) It fails in any other way to comply with stipulated drug standards.
第三十五條藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)和醫(yī)療單位直接接觸藥品的工作人員，必須每年進(jìn)行健康檢查?；加袀魅静』蛘咂渌赡芪廴舅幤返募膊〉幕颊撸坏脧氖轮苯咏佑|藥品的工作。
[Article 35] Personnel of drug-producing enterprises, drug-handling
enterprises and medical treatment units who come into direct contact with drugs
must undergo a medical examination annually. Persons suffering from contagious
diseases or any other disease that could contaminate drugs may not engage in
work involving direct contact with drugs.
第六章藥品的包裝和分裝
CHAPTER VI THE PACKAGING AND REPACKAGING OF DRUGS
第三十六條藥品包裝必須適合藥品質(zhì)量的要求，方便儲(chǔ)存、運(yùn)輸和醫(yī)療使用。規(guī)定有效期的藥品，必須在包裝上注明有效期。
[Article 36] The packaging of drugs must be appropriate to the requirements of
the quality of the drug and must facilitate their storage, transportation and
use. Where a period of efficacy for a drug has been fixed, the period of
efficacy must be clearly indicated on the package.
發(fā)運(yùn)中藥材必須有包裝。每件包裝上必須注明品名、產(chǎn)地、日期、調(diào)出單位，并附有質(zhì)量合格的標(biāo)志。
Where Chinese medicinal materials are to be transported, they must be
packaged. On each package, the name of the product, its place of origin, the
date and the name of the dispatching unit must be clearly indicated and it must
be marked to indicate that the quality is up to standard.
第三十七條藥品包裝必須按照規(guī)定貼有標(biāo)簽并附有說明書。
[Article 37] Drug packages must, in accordance with regulations, be labelled
and have an instruction booklet attached.
標(biāo)簽或說明書上必須注明藥品的品名、規(guī)格、生產(chǎn)企業(yè)、批準(zhǔn)文號(hào)、產(chǎn)品批號(hào)、主要成份、適應(yīng)癥、用法、用量、禁忌、不良反應(yīng)和注意事項(xiàng)。
The name of the drug, its specifications, the producing unit, approval number,
product batch number, principal ingredients, diseases for which it is indicated,
manner of use, side-effects and points to note must be clearly set out on the
label or in the instruction booklet.
麻醉藥品、精神藥品、毒性藥品、放射性藥品和外用藥品的標(biāo)簽必須印有規(guī)定標(biāo)志。
The labels of narcotic drugs, psychotropic drugs, poisonous drugs, radioactive
drugs and drugs for external use only must bear the prescribed mark.
第三十八條藥品經(jīng)營(yíng)企業(yè)分裝藥品，必須具有與所分裝藥品相適應(yīng)的設(shè)施和衛(wèi)生條件，由藥學(xué)技術(shù)人員負(fù)責(zé)，分裝記錄必須完整準(zhǔn)確。
[Article 38] A drug-handling enterprise engaged in the repackaging of drugs
must have equipment and hygienic conditions appropriate for the quantity of
drugs repackaged. It must be under the charge of pharmaceutical technicians;
records of the repackaging must be complete and precise.
分裝藥品必須附有說明書，在包裝上注明品名、規(guī)格、生產(chǎn)企業(yè)和產(chǎn)品批號(hào)、分裝單位和分裝批號(hào)。規(guī)定有效期的藥品，分裝后必須注明有效期。
An instruction booklet must be attached to a repackaged drug. The product
name, specifications, name of the production unit and product batch number and
of the repackaging unit and repackaging batch number shall be set out clearly on
the package. Where a period of efficacy has been set for the drug, when it has
been repackaged, the period of efficacy must be clearly indicated.
第七章特殊管理的藥品
CHAPTER VII DRUGS UNDER SPECIAL CONTROL
第三十九條國(guó)家對(duì)麻醉藥品、精神藥品、毒性藥品、放射性藥品，實(shí)行特殊的管理辦法。管理辦法由國(guó)務(wù)院制定。
[Article 39] The State imposes special controls on narcotic drugs,
psychotropic drugs, poisons and radioactive drugs. The controls will be
stipulated by the State Council.
第四十條麻醉藥品，包括原植物，只準(zhǔn)由國(guó)務(wù)院衛(wèi)生行政部門會(huì)同有關(guān)部門指定的單位生產(chǎn)，并由省、自治區(qū)、直轄市衛(wèi)生行政部門會(huì)同有關(guān)部門指定的單位按照規(guī)定供應(yīng)。
[Article 40] The production of narcotic drugs, including the original plant,
may only be undertaken by units appointed to do so by the department of the
State Council administering health and relevant departments acting jointly, and
supply may only be undertaken by units appointed by the department of the
province, autonomous region or municipality under the direct control of the
Central Government administering health and the relevant departments acting
jointly.
第八章藥品商標(biāo)和廣告的管理
CHAPTER VIII ADMINISTRATION OF DRUG TRADEMARKS AND ADVERTISING
第四十一條除中藥材、中藥飲片外，藥品必須使用注冊(cè)商標(biāo)；未經(jīng)核準(zhǔn)注冊(cè)的，不得在市場(chǎng)銷售。
[Article 41] With the exception of Chinese medicinal materials and Chinese
medicines sliced and prepared for decoction, drugs must use a registered
trademark and may not be sold on the market until examined and approved for
registration.
注冊(cè)商標(biāo)必須在藥品的包裝和標(biāo)簽上注明。
The registered trademark must be clearly shown on the package and label of the
drug.
第四十二條藥品廣告必須經(jīng)省、自治區(qū)、直轄市衛(wèi)生行政部門審查批準(zhǔn)；未經(jīng)批準(zhǔn)的，不得刊登、播放、散發(fā)和張貼。
[Article 42] An advertisement for a drug must be examined and approved by the
department of the province, autonomous region or municipality under the direct
control of the Central Government responsible for administering health; unless
it is approved, it may not be published, broadcast, distributed or displayed on
a poster.
第四十三條外國(guó)企業(yè)在我國(guó)申請(qǐng)辦理藥品廣告，必須提供生產(chǎn)該藥品的國(guó)家（地區(qū)）批準(zhǔn)的證明文件、藥品說明書和有關(guān)資料。
[Article 43] Where a foreign enterprise applies to advertise a drug in this
country, it must submit documents proving approval of the drug from the country
(or place) of its production, a written description of the drug and relevant
material.
第四十四條藥品廣告的內(nèi)容必須以國(guó)務(wù)院衛(wèi)生行政部門或者省、自治區(qū)、直轄市衛(wèi)生行政部門批準(zhǔn)的說明書為準(zhǔn)。
[Article 44] The contents of an advertisement for a drug must be in accordance
with the explanatory booklet approved by the department of the State Council
administering health or the department of the province, autonomous region or
municipality under the direct control of the Central Government administering
health.
第九章藥品監(jiān)督
CHAPTER IX DRUG CONTROL
第四十五條縣級(jí)以上衛(wèi)生行政部門行使藥品監(jiān)督職權(quán)。
[Article 45] Departments administering health above the county level exercise
the power of supervision over drugs.
縣級(jí)以上衛(wèi)生行政部門，可以設(shè)置藥政機(jī)構(gòu)和藥品檢驗(yàn)機(jī)構(gòu)。
Departments administering health at above county level may establish drug
administration bodies and drug inspection bodies.
第四十六條縣級(jí)以上衛(wèi)生行政部門設(shè)藥品監(jiān)督員。藥品監(jiān)督員由藥學(xué)技術(shù)人員擔(dān)任，由同級(jí)人民政府審核發(fā)給證書。
[Article 46] Departments administering health at above county level will
appoint Drug Controllers. Drug Controllers will be appointed from those holding
the position of pharmaceutical technicians; they shall be examined, and a
certificate will be issued by the People's Governments at that level.
第四十七條藥品監(jiān)督員有權(quán)按照規(guī)定對(duì)轄區(qū)內(nèi)的藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)和醫(yī)療單位的藥品質(zhì)量進(jìn)行監(jiān)督、檢查、抽驗(yàn)，必要時(shí)可以按照規(guī)定抽取樣品和索取有關(guān)資料，有關(guān)單位不得拒絕和隱瞞。
[Article 47] A Drug Controller has the power, in accordance with regulations,
to control, inspect and test the quality of drugs in drug-producing enterprises,
drug-handling enterprises and medical treatment units within the Controller's
area of jurisdiction. If necessary, the Drug Controller may, in accordance with
regulations, take samples and obtain relevant data which the relevant unit may
not refuse to provide and may not conceal.
藥品監(jiān)督員對(duì)藥品的生產(chǎn)企業(yè)和科研單位提供的技術(shù)資料，負(fù)責(zé)保密。
Drug Controllers are responsible for keeping the technical data provided by
drug-manufacturing enterprises or scientific research units confidential.
第四十八條藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)和醫(yī)療單位，應(yīng)當(dāng)經(jīng)常考察本單位所生產(chǎn)、經(jīng)營(yíng)、使用的藥品的質(zhì)量、療效和不良反應(yīng)。
[Article 48] Drug-producing enterprises, drug-handling enterprises and medical
treatment units shall regularly inspect and study the quality, efficacy and
side-effects of drugs produced, handled or used by them.
醫(yī)療單位發(fā)現(xiàn)藥品中毒事故，必須及時(shí)向當(dāng)?shù)匦l(wèi)生行政部門報(bào)止。
If a medical treatment unit discovers a case of poisoning in relation to a
drug, it must immediately report it to the department administering health in
that area.
第四十九條藥品生產(chǎn)企業(yè)和藥品經(jīng)營(yíng)企業(yè)的藥品檢驗(yàn)機(jī)構(gòu)或者人員，受當(dāng)?shù)厮幤窓z驗(yàn)機(jī)構(gòu)的業(yè)務(wù)指導(dǎo)。
[Article 49] The drug-inspection body or personnel of a drug-producing
enterprise or drug-handling enterprise will receive guidance in their
professional work from the drug-inspection organ of that area.
第十章法律責(zé)任
CHAPTER X LEGAL RESPONSIBILITIES
第五十條生產(chǎn)、銷售假藥的，沒收假藥和違法所得，處以罰款，并可以責(zé)令該單位停產(chǎn)、停業(yè)整頓或者吊銷《藥品生產(chǎn)企業(yè)許可證》、《藥品經(jīng)營(yíng)企業(yè)許可證》、《制劑許可證》。
[Article 50] Where spurious drugs are produced or sold, the spurious drugs and
the illegally obtained income will be confiscated and a fine will be imposed. In
addition, the relevant unit may be ordered to stop production or stop operations
for rectification or its "Drug-production Enterprise Licence", "Drug-handling
Enterprise Licence" or "Dispensing Licence" may be revoked.
對(duì)生產(chǎn)、銷售假藥，危害人民健康的個(gè)人或者單位直接責(zé)任人員，依照刑法第一百六十四條規(guī)定追究刑事責(zé)任。
In pursuance of the regulations of Article 164 of the Penal Code, criminal
liability will be investigated and determined in relation to individuals or
units directly involved in the production or sale of spurious drugs endangering
the people's health.
第五十一條生產(chǎn)、銷售劣藥的，沒收劣藥和違法所得，可以并處罰款；情節(jié)嚴(yán)重的，并責(zé)令該單位停產(chǎn)、停業(yè)整頓或者吊銷《藥品生產(chǎn)企業(yè)許可證》、《藥品經(jīng)營(yíng)企業(yè)許可證》、《制劑許可證》。
[Article 51] Where inferior drugs are produced or sold, the inferior drugs and
the illegally obtained income will be confiscated and a fine may also be
imposed; if the circumstances are serious, the relevant unit may be ordered to
stop production or stop its operations and rectify itself, or its
"Drug-production Enterprise Licence", "Drug-handling Enterprise Licence" or
"Dispensing Licence" may be revoked.
對(duì)生產(chǎn)銷售劣藥，危害人民健康，造成嚴(yán)重后果的個(gè)人或單位直接責(zé)任人員，比照刑法第一百六十四條的規(guī)定追究刑事責(zé)任。
In pursuance of Article 164 of the Penal Code, criminal liability will be
investigated and determined in relation to individuals or units directly
involved in the production or sale of inferior drugs endangering the people's
health.
第五十二條未取得《藥品生產(chǎn)企業(yè)許可證》、《藥品經(jīng)營(yíng)企業(yè)許可證》、《制劑許可證》生產(chǎn)藥品、經(jīng)營(yíng)藥品或者配制制劑的，責(zé)令該單位停產(chǎn)、停業(yè)或者停止配制制劑，沒收全部藥品和違法所得，可以并處罰款。
[Article 52] Where drugs are manufactured, handled or made up without a
"Drug-production Enterprise Licence", Drug-handling Enterprise Licence" or
"Dispensing Licence", the relevant unit will be ordered to stop production, stop
operations or stop preparing medications. All of the illegally-produced drugs
and the illegally-obtained income shall be confiscated and a fine may also be
imposed.
第五十三條違反本法關(guān)于藥品生產(chǎn)、藥品經(jīng)營(yíng)的管理的其他規(guī)定的，處以警告或者罰款。
[Article 53] A violation of any other provision of this law in relation to the
administration of drug production or handling will be punished by a caution or
by a fine.
第五十四條本法規(guī)定的行政處罰，由縣級(jí)以上衛(wèi)生行政部門決定。違反本法第十五條規(guī)定、第八章有關(guān)廣告管理的規(guī)定的行政處罰，由工商行政管理部門決定。
[Article 54] Any decision relating to the imposition of an administrative
penalty pursuant to this law shall be made by the department administering
health at above the county level. Any decision relating to the imposition of a
penalty for and offence against Article 15 of this law or the provisions of
Chapter VIII of this law with respect to the advertising of drugs, shall be made
by the department administering industry and commerce. In relation to the
penalty of ordering a drug-producing enterprise or drug-handling enterprise
which is directly under the management of the Central Government or the People's
Government of a province, autonomous region or municipality directly under the
control of the Central Government to stop production or stop its operations for
more than seven days, or of revoking its "Drug-production Enterprise Licence",
or "Drug-handling Enterprise Licence", the department of the province,
autonomous region or municipality under the direct control of the Central
Government administering health shall submit it to the People's Government at
the same level for decision.
對(duì)中央或者省、自治區(qū)、直轄市人民政府直接管轄的藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)處以停產(chǎn)、停業(yè)整頓7天以上或者吊銷《藥品生產(chǎn)企業(yè)許可證》、
《藥品經(jīng)營(yíng)企業(yè)許可證》處罰的，由省、自治區(qū)、直轄市衛(wèi)生行政部門報(bào)同級(jí)人民政府決定。對(duì)市、縣或者市、縣以下人民政府管轄的藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)處以停產(chǎn)，停業(yè)整頓
7天以上或者吊銷《藥品生產(chǎn)企業(yè)許可證》、《藥品經(jīng)營(yíng)企業(yè)許可證》處罰的，由市、縣人民政府衛(wèi)生行政部門報(bào)同級(jí)人民政府決定。
In relation to a penalty ordering a drug-producing enterprise or drug-handling
enterprise under the direct management of the People's Government at or below
the city or county level to stop production or stop operations for more than
seven days or of revoking its "Drug-production Enterprise Licence" or its
"Drug-handling Enterprise Licence", the department of the city or county
People's Government administering health shall submit the matter to the People's
Government of the same level for decision.
沒收的藥品由衛(wèi)生行政部門監(jiān)督處理。
Confiscated drugs shall be disposed of under the supervision of the department
responsible for health administration.
第五十五條當(dāng)事人對(duì)行政處罰決定不服的，可以在接到處罰通知之日起 15 天內(nèi)向人民法院起訴。
[Article 55] If a party objects to the decision to impose a penalty on him, he
may, within 15 days from the date of receipt of notification of the penalty,
bring an action in the People's Court. H
但是，對(duì)衛(wèi)生行政部門作出的藥品控制的決定，當(dāng)事人必須立即執(zhí)行。對(duì)處罰決定不履行逾期又不起訴的，由作出行政處罰決定的機(jī)關(guān)申請(qǐng)人民法院強(qiáng)制執(zhí)行。
owever, in the case of a decision relating to drug control taken by the
department responsible for health administration, the party shall immediately
comply. Where the decision has not been complied with within the time limit and
no action has been brought, the People's Court shall compulsorily enforce
compliance upon application by the organ which made the decision.
第五十六條違反本法，造成藥品中毒事故的，致害單位或者個(gè)人應(yīng)當(dāng)負(fù)損害賠償責(zé)任。受害人可以請(qǐng)求縣級(jí)以上衛(wèi)生行政部門處理；當(dāng)事人不服的，可以向人民法院起訴。受害人也可以直接向人民法院起訴。
[Article 56] In case of drug poisoning caused by a breach of this law, the
unit or person who caused it shall be liable to pay compensation. The person
suffering harm may request a department administering health at above county
level to handle the matter; if the party who caused the harm objects, he or it
may bring an action in the People's Court. The person suffering harm may also
sue directly in the People's Court.
損害賠償要求，應(yīng)當(dāng)從受害人或者其代理人知道或者應(yīng)當(dāng)知道之日起 1年內(nèi)提出；超過期限的，不予受理。
A demand to be compensated for damage shall be submitted within a period of
one year from the date on which the victim or his representative became aware or
ought to have become aware of it. When this period has expired, the claim will
not be entertained.
第五十七條本法下列用語的含義是：
[Article 57] The expressions used in this law are defined as follows:
藥品：指用于預(yù)防、治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機(jī)能并規(guī)定有適應(yīng)癥、用法和用量的物質(zhì)，
"Drug" refers to a substance used for the prevention, treatment and diagnosis
of human diseases, and with the object of regulating human physiological
functions, with stipulated indications, usage and dosage.
包括中藥材、中藥飲片、中成藥、化學(xué)原料藥及其制劑、抗生素、生化藥品、放射性藥品、血清疫苗、血液制品和診斷藥品等。
It includes Chinese medicinal materials and Chinese medicines sliced and
prepared for decoction, prepared Chinese medicines, chemical raw material drugs
and their components, antibiotics, biochemical drugs, radioactive drugs, blood
serums and vaccines, blood products, diagnostic drugs and so on.
新藥指我國(guó)未生產(chǎn)過的藥品。
"New drugs" refers to those drugs which have never been produced in this
country.
輔料指生產(chǎn)藥品和調(diào)配處方時(shí)所用的賦形劑和附加劑。
"Supplementary materials" refers to excipients and additives used in the
production and making up of drugs.
藥品生產(chǎn)企業(yè)指生產(chǎn)藥品的專營(yíng)企業(yè)或者兼營(yíng)企業(yè)。
"Drug-producing enterprise" refers to those enterprises exclusively or
partially engaged in the production of drugs.
藥品經(jīng)營(yíng)企業(yè)指經(jīng)營(yíng)藥品的專營(yíng)企業(yè)或者兼營(yíng)企業(yè)。
"Drug-handling enterprise" refers to those enterprises exclusively or
partially engaged in the handling of drugs.
第五十八條本法所說的藥品生產(chǎn)，不包括中藥材的種植、采集和飼養(yǎng)。
[Article 58] The production of drugs referred to in this law does not include
the cultivation and collection of raw materials for Chinese medicines or the
raising of animals in relation to Chinese medicines.
第五十九條國(guó)務(wù)院衛(wèi)生行政部門根據(jù)本法制定實(shí)施辦法報(bào)國(guó)務(wù)院批準(zhǔn)施行。
[Article 59] Measures for the implementation of this law will be set down by
the State Council department responsible for health administration and submitted
to the State Council for approval and implementation.
中國(guó)人民解放軍特需藥品的管理辦法由國(guó)家軍事主管部門制定。
Special provisions for the management of drugs in the People's Liberation Army
will be laid down by the department in charge of national military affairs.
第六十條本法自一九八五年七月一日起施行。
[Article 60] This law shall come into force on July 1, 1985.
中華人民共和國(guó)藥品管理法
The Pharmaceutical Administration Law of the People's Republic of China
第一章 總 則
Chapter I General Provisions
第一條 為加強(qiáng)藥品監(jiān)督管理，保證藥品質(zhì)量，保障人體用藥安全，維護(hù)人民身體健康和用藥的合法權(quán)益，特制定本法。
Article 1 This law is formulated to enhance the supervision and control of
pharmaceuticals, ensure their quality, guarantee safety in medication, and
safeguard the health and legal rights and interests of the people.
第二條 在中華人民共和國(guó)境內(nèi)從事藥品的研制、生產(chǎn)、經(jīng)營(yíng)、使用和監(jiān)督管理的單位或者個(gè)人，必須遵守本法。
Article 2 The law shall be applicable to any units or individuals engaged in
research, production, trade, use, supervision and management of pharmaceuticals
within the territory of the People's Republic of China.
第三條 國(guó)家發(fā)展現(xiàn)代藥和傳統(tǒng)藥，充分發(fā)揮其在預(yù)防、醫(yī)療和保健中的作用。
Article 3 The State shall develop both modern and traditional medicines
encourage their role in the prevention and treatment of diseases and in health
care.
國(guó)家保護(hù)野生藥材資源，鼓勵(lì)培育中藥材。
The State shall protect the resources of wild medicinal resources and
encourage the domestic cultivation of Chinese traditional medicinal crops.
第四條 國(guó)家鼓勵(lì)研究和創(chuàng)制新藥，保護(hù)公民、法人和其他組織研究、開發(fā)新藥的合法權(quán)益。
Article 4 The State shall encourage the research and production of new
medicine and protect the legal rights and interests of its citizens, natural
persons and other organizations in the research and development of new medicine.
第五條 國(guó)務(wù)院藥品監(jiān)督管理部門主管全國(guó)藥品監(jiān)督管理工作。國(guó)務(wù)院有關(guān)部門在各自的職責(zé)范圍內(nèi)負(fù)責(zé)與藥品有關(guān)的監(jiān)督管理工作。
Article 5 The pharmaceuticals supervisory and administrative departments under
the State Council shall be responsible for the supervision and control of
pharmaceuticals throughout the country. Other relevant departments under the
State Council shall be responsible for the supervision and control of
pharmaceuticals related to the scope of their functions.
省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門負(fù)責(zé)本行政區(qū)域內(nèi)的藥品監(jiān)督管理工作。省、自治區(qū)、直轄市人民政府有關(guān)部門在各自的職責(zé)范圍內(nèi)負(fù)責(zé)與藥品有關(guān)的監(jiān)督管理工作。
The pharmaceutical supervisory and administrative departments of the
provinces, autonomous regions and municipalities directly under the central
government shall be responsible for the supervision and control of
pharmaceuticals within their administrative regions. Other relevant departments
of the provinces, autonomous regions and municipalities directly under the
central government shall be responsible for the supervision and control of
pharmaceuticals related to the scope of their functions.
國(guó)務(wù)院藥品監(jiān)督管理部門應(yīng)當(dāng)配合國(guó)務(wù)院經(jīng)濟(jì)綜合主管部門，執(zhí)行國(guó)家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策。
The pharmaceutical supervisory and administrative departments under the State
Council shall cooperate with the general administrative department of the
economy under the State Council to carry out pharmaceutical development plans
and industrial policies formulated by the State.
第六條 藥品監(jiān)督管理部門設(shè)置或者確定的藥品檢驗(yàn)機(jī)構(gòu)，承擔(dān)依法實(shí)施藥品審批和藥品質(zhì)量監(jiān)督檢查所需的藥品檢驗(yàn)工作。
Article 6 The pharmaceutical inspection institutions established or approved
by the pharmaceutical supervisory and administrative departments shall be
charged with the work of pharmaceutical examination and approval, as well as
quality inspection, in accordance with laws and regulations.
第二章 藥品生產(chǎn)企業(yè)管理
Chapter II Administration of Pharmaceutical Producing Enterprises
第七條 開辦藥品生產(chǎn)企業(yè)，須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給《藥品生產(chǎn)許可證》，
Article 7 The establishment of a pharmaceutical producing enterprise must be
approved by and issued a Pharmaceutical Production License by the pharmaceutical
supervisory and administrative department of the province, autonomous region, or
municipality directly under the Central government in which the enterprise is
located.
憑《藥品生產(chǎn)許可證》到工商行政管理部門辦理登記注冊(cè)。無《藥品生產(chǎn)許可證》的，不得生產(chǎn)藥品。
The establishment shall be registered at the industry and commerce
administrative department based on the Pharmaceutical Production License,
without which no pharmaceuticals shall be produced.
《藥品生產(chǎn)許可證》應(yīng)當(dāng)標(biāo)明有效期和生產(chǎn)范圍，到期重新審查發(fā)證。
The Pharmaceutical Production License shall bear the scope of production and a
period of validity, and upon expiration a new license shall be issued after
examination for its renewal.
藥品監(jiān)督管理部門批準(zhǔn)開辦藥品生產(chǎn)企業(yè)，除依據(jù)本法第八條規(guī)定的條件外，還應(yīng)當(dāng)符合國(guó)家制定的藥品行業(yè)發(fā)展規(guī)劃和產(chǎn)業(yè)政策，防止重復(fù)建設(shè)。
The approval of the establishment of pharmaceutical producing enterprises by
the pharmaceutical supervisory and administrative departments shall be in
conformity with Article 8 of this law, as well as the pharmaceutical development
plan and the industrial policies formulated by the State to avoid the instance
of a repeat establishment.
第八條 開辦藥品生產(chǎn)企業(yè)，必須具備以下條件：
Article 8 To establish a pharmaceutical producing enterprise, the following
requirements must be met:
（一）具有依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員、工程技術(shù)人員及相應(yīng)的技術(shù)工人；
(1) It shall be staffed with legally certified pharmaceutical technical
personnel, engineering technical personnel, as well as corresponding skilled
workers.
?。ǘ┚哂信c其藥品生產(chǎn)相適應(yīng)的廠房、設(shè)施和衛(wèi)生環(huán)境；
(2) It shall have factory premises, facilities and a sanitary environment
suitable for the medicines produced.
（三）具有能對(duì)所生產(chǎn)藥品進(jìn)行質(zhì)量管理和質(zhì)量檢驗(yàn)的機(jī)構(gòu)、人員以及必要的儀器設(shè)備；
(3) It shall have a unit or competent personnel capable of inspecting the
quality of the medicines produced, as well as necessary instruments and
equipment.
（四）具有保證藥品質(zhì)量的規(guī)章制度。
(4) It shall have rules and regulations to ensure the quality of medicines.
第九條
藥品生產(chǎn)企業(yè)必須按照國(guó)務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的《藥品生產(chǎn)質(zhì)量管理規(guī)范》組織生產(chǎn)。藥品監(jiān)督管理部門按照規(guī)定對(duì)藥品生產(chǎn)企業(yè)是否符合《藥品生產(chǎn)質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對(duì)認(rèn)證合格的，發(fā)給認(rèn)證證書。
Article 9 Pharmaceutical producing enterprises must organize production in
accordance with the "Standards for Quality Control of Pharmaceutical Production"
formulated by the pharmaceutical supervisory and administrative departments
under the State Council on the basis of this Law. Pharmaceutical supervisory and
administrative departments shall confirm whether the pharmaceutical producing
enterprises have met the requirements of the "Standards," and shall issue
certificates to those qualified ones.
《藥品生產(chǎn)質(zhì)量管理規(guī)范》的具體實(shí)施辦法、實(shí)施步驟由國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定。
The detailed implementation measures and implementation process of the
"Standards for Quality Control of Pharmaceutical Production" shall be formulated
by the pharmaceutical supervisory and administrative department under the State
Council.
第十條
除中藥飲片的炮制外，藥品必須按照國(guó)家藥品標(biāo)準(zhǔn)和國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)的生產(chǎn)工藝進(jìn)行生產(chǎn)，生產(chǎn)記錄必須完整準(zhǔn)確。藥品生產(chǎn)企業(yè)改變影響藥品質(zhì)量的生產(chǎn)工藝的，必須報(bào)原批準(zhǔn)部門審核批準(zhǔn)。
Article 10 Except in the preparation of traditional Chinese medicines into
ready-to-use forms, pharmaceuticals must be produced in accordance with the
national pharmaceutical standard and the technological procedures approved by
the supervisory and administrative departments of pharmaceuticals under the
State Council, and the record of production must be complete and accurate. The
changes of technological procedure made by the pharmaceutical producing
enterprises which affect the quality of the pharmaceuticals shall be examined
and approved by the original approval authorities.
中藥飲片必須按照國(guó)家藥品標(biāo)準(zhǔn)炮制；國(guó)家藥品標(biāo)準(zhǔn)沒有規(guī)定的，必須按照省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的炮制規(guī)范炮制。省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的炮制規(guī)范應(yīng)當(dāng)報(bào)國(guó)務(wù)院藥品監(jiān)督管理部門備案。
The process for preparing traditional Chinese medicines into ready-to-use
forms must conform to the national pharmaceutical standards, and in the absence
of such standards, the process must conform to the processing standards
stipulated by the supervisory and administrative departments of pharmaceuticals
of the provinces, autonomous regions, or municipalities directly under the
central government. The processing standards stipulated by the supervisory and
administrative departments of pharmaceuticals of the provinces, autonomous
regions, or municipalities directly under the central governments shall be
placed on record at the pharmaceutical supervisory and administrative department
under the State Council.
第十一條 生產(chǎn)藥品所需的原料、輔料，必須符合藥用要求。
Article 11 The raw and supplementary materials used for the production of
pharmaceuticals must conform to the requirements for medicinal use.
第十二條
藥品生產(chǎn)企業(yè)必須對(duì)其生產(chǎn)的藥品進(jìn)行質(zhì)量檢驗(yàn)；不符合國(guó)家藥品標(biāo)準(zhǔn)或者不按照省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門制定的中藥飲片炮制規(guī)范炮制的，不得出廠。
Article 12 The pharmaceutical producing enterprises must conduct quality
inspections on the pharmaceuticals they produce; products which do not meet
national pharmaceutical standards or are not prepared in conformity with the
processing standards stipulated by the pharmaceutical supervisory and
administrative departments of the provinces, autonomous regions, or
municipalities directly under the central government shall not leave the
factory.
第十三條 經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門或者國(guó)務(wù)院藥品監(jiān)督管理部門授權(quán)的省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，藥品生產(chǎn)企業(yè)可以接受委托生產(chǎn)藥品。
Article 13 Pharmaceutical producing enterprises can accept the authorization
to produce pharmaceuticals after they obtain approval from the pharmaceutical
supervisory and administrative department under the State Council or the
pharmaceutical supervisory and administrative departments of the provinces,
autonomous regions, or municipalities directly under the central government
authorized by the supervisory and administrative department of pharmaceuticals
under the State Council.
第三章 藥品經(jīng)營(yíng)企業(yè)管理
Chapter III Administration of Pharmaceutical Trading Enterprises
第十四條 開辦藥品批發(fā)企業(yè)，須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給《藥品經(jīng)營(yíng)許可證》；
Article 14 The establishment of pharmaceutical wholesale enterprises must be
sanctioned by the competent local authorities of the production and trade of
pharmaceuticals of the provinces, autonomous regions or municipalities directly
under the central government, which will issue a Pharmaceutical Trade License.
開辦藥品零售企業(yè)，須經(jīng)企業(yè)所在地縣級(jí)以上地方藥品監(jiān)督管理部門批準(zhǔn)并發(fā)給《藥品經(jīng)營(yíng)許可證》，憑《藥品經(jīng)營(yíng)許可證》到工商行政管理部門辦理登記注冊(cè)。無《藥品經(jīng)營(yíng)許可證》的，不得經(jīng)營(yíng)藥品。
The establishment of pharmaceutical retail enterprises must be sanctioned by
local authorities for the supervision and control of pharmaceuticals at or above
the county level, which will issue a Pharmaceutical Trade License, on the basis
of which registration at the industry and commerce administrative departments
shall be conducted. Without the Pharmaceutical Trade License, any enterprises
shall not engage in the trade of pharmaceuticals.
《藥品經(jīng)營(yíng)許可證》應(yīng)當(dāng)標(biāo)明有效期和經(jīng)營(yíng)范圍，到期重新審查發(fā)證。
A Pharmaceutical Trade License shall bear a scope of trade and a period of
validity, and upon expiration a new license shall be issued after examination
for its renewal.
藥品監(jiān)督管理部門批準(zhǔn)開辦藥品經(jīng)營(yíng)企業(yè)，除依據(jù)本法第十五條規(guī)定的條件外，還應(yīng)當(dāng)遵循合理布局和方便群眾購(gòu)藥的原則。
The approval of the establishment of pharmaceutical trading enterprises by the
pharmaceutical supervisory and administrative departments shall adhere to the
principle of reasonable positioning and convenience for buying of
pharmaceuticals, and in addition must conform to Article 15 of this Law.
第十五條 開辦藥品經(jīng)營(yíng)企業(yè)必須具備以下條件：
Article 15 To establish a pharmaceutical trading enterprise, the following
requirements must be met
?。ㄒ唬┚哂幸婪ń?jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員；
(1) 1 It shall be staffed with legally certified pharmaceutical technical
personnel.
?。ǘ┚哂信c所經(jīng)營(yíng)藥品相適應(yīng)的營(yíng)業(yè)場(chǎng)所、設(shè)備、倉(cāng)儲(chǔ)設(shè)施、衛(wèi)生環(huán)境；
(2) It shall have business premises, equipment, storage facilities and a
sanitary environment suitable for the pharmaceuticals in which it trades.
?。ㄈ┚哂信c所經(jīng)營(yíng)藥品相適應(yīng)的質(zhì)量管理機(jī)構(gòu)或者人員；
(3) It shall have a quality control organ or personnel suitable for the
pharmaceuticals in which it trades.
（四）具有保證所經(jīng)營(yíng)藥品質(zhì)量的規(guī)章制度。
(4) It shall have rules and regulations to ensure the quality of the
pharmaceuticals in which it trades.
第十六條 藥品經(jīng)營(yíng)企業(yè)必須按照國(guó)務(wù)院藥品監(jiān)督管理部門依據(jù)本法制定的《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》經(jīng)營(yíng)藥品。
Article 16 Pharmaceutical producing enterprises must trade in pharmaceuticals
in accordance with the "Standards for Quality Control of Pharmaceutical Trading"
stipulated by the pharmaceutical supervisory and administrative departments
under the State Council on the basis of this Law.
藥品監(jiān)督管理部門按照規(guī)定對(duì)藥品經(jīng)營(yíng)企業(yè)是否符合《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》的要求進(jìn)行認(rèn)證；對(duì)認(rèn)證合格的，發(fā)給認(rèn)證證書。
Pharmaceutical supervisory and administrative departments shall certify
whether pharmaceutical trading enterprises meet the requirements of the
"Standards for Quality Control of Pharmaceutical Trading" in accordance with
relevant regulations, and issue certifications to qualified enterprises.
《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》的具體實(shí)施辦法、實(shí)施步驟由國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定。
Detailed implementation measures and procedures for the "Standards for Quality
Control of Pharmaceutical Trading" shall be stipulated by the pharmaceutical
supervisory and administrative departments under the State Council.
第十七條 藥品經(jīng)營(yíng)企業(yè)購(gòu)進(jìn)藥品，必須建立并執(zhí)行進(jìn)貨檢查驗(yàn)收制度，驗(yàn)明藥品合格證明和其他標(biāo)識(shí)；不符合規(guī)定要求的，不得購(gòu)進(jìn)。
Article 17 Pharmaceutical trading enterprises must formulate and implement
check and approval rules for the purchase of pharmaceuticals, and check
pharmaceutical certifications and other marks while purchasing pharmaceuticals.
Pharmaceuticals that do not meet the required standards must not be purchased.
第十八條
藥品經(jīng)營(yíng)企業(yè)購(gòu)銷藥品，必須有真實(shí)完整的購(gòu)銷記錄。購(gòu)銷記錄必須注明藥品的通用名稱、劑型、規(guī)格、批號(hào)、有效期、生產(chǎn)廠商、購(gòu)（銷）貨單位、購(gòu)（銷）貨數(shù)量、購(gòu)銷價(jià)格、購(gòu)（銷）貨日期及國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定的其他內(nèi)容。
Article 18 Pharmaceutical trading enterprises shall keep accurate and complete
records of purchased pharmaceuticals. Purchasing records must bear information
on the pharmaceutical product's generic names, types, specifications, batches,
valid periods, producing enterprises, purchasing (selling) units, purchasing
(selling) quantity, purchasing and selling price, purchasing (selling) date and
other contents required by the pharmaceutical supervisory and administrative
department under the State Council.
第十九條
藥品經(jīng)營(yíng)企業(yè)銷售藥品必須準(zhǔn)確無誤，并正確說明用法、用量和注意事項(xiàng)；調(diào)配處方必須經(jīng)過核對(duì)，對(duì)處方所列藥品不得擅自更改或者代用。對(duì)有配伍禁忌或者超劑量的處方，應(yīng)當(dāng)拒絕調(diào)配；必要時(shí)，經(jīng)處方醫(yī)師更正或者重新簽字，方可調(diào)配。
Article 19 It is imperative for pharmaceutical trading enterprises, in the
sale of pharmaceuticals, to be accurate and free of mistakes, and to provide
correct directions for use, dosage and precautions. Prescriptions being
dispensed must be checked. Pharmaceutical products listed in the prescription
must not be presumptuously changed or substituted. Prescriptions containing
incompatible substances or excessive dosages shall be rejected by the
dispensary. If necessary, such prescriptions can be dispensed after they have
been corrected or re-signed by the doctors who wrote them.
藥品經(jīng)營(yíng)企業(yè)銷售中藥材，必須標(biāo)明產(chǎn)地。
When traditional Chinese medicinal materials are offered for sale by
pharmaceutical trading enterprises, their origin must be indicated.
第二十條 藥品經(jīng)營(yíng)企業(yè)必須制定和執(zhí)行藥品保管制度，采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥品質(zhì)量。
Article 20 Rules for storage of pharmaceuticals shall be formulated and
implemented by pharmaceutical trading enterprises, which must adopt necessary
measures to facilitate cold storage and protection against freezing, moisture,
insects and rodents to ensure pharmaceutical quality.
藥品入庫(kù)和出庫(kù)必須執(zhí)行檢查制度。
An inspection system shall be carried out for pharmaceuticals entering or
leaving a warehouse
第二十一條 城鄉(xiāng)集市貿(mào)易市場(chǎng)可以出售中藥材，國(guó)務(wù)院另有規(guī)定的除外。
Article 21 Unless otherwise stipulated by the State, traditional Chinese
medicinal materials may be marketed at urban or rural fairs.
城鄉(xiāng)集市貿(mào)易市場(chǎng)不得出售中藥材以外的藥品，但持有《藥品經(jīng)營(yíng)許可證》的藥品零售企業(yè)在規(guī)定的范圍內(nèi)可以在城鄉(xiāng)集市貿(mào)易市場(chǎng)設(shè)點(diǎn)出售中藥材以外的藥品。具體辦法由國(guó)務(wù)院規(guī)定。
Pharmaceuticals other than traditional Chinese medicinal materials may not be
sold at urban or rural fairs, but those retail enterprises which have the
Pharmaceutical Trade License may set up stalls at urban or rural fairs to sell
pharmaceuticals other than traditional Chinese medicinal materials within
prescribed areas. Detailed measures shall be stipulated by the State Council.
第四章 醫(yī)療機(jī)構(gòu)的藥劑管理
Chapter IV Administration of Pharmaceuticals at Medical Organizations
第二十二條 醫(yī)療機(jī)構(gòu)必須配備依法經(jīng)過資格認(rèn)定的藥學(xué)技術(shù)人員。非藥學(xué)技術(shù)人員不得直接從事藥劑技術(shù)工作。
Article 22 Medical organizations must be staffed with legally certified
pharmaceutical technical personnel. Non-pharmaceutical technical personnel may
not be directly engaged in the technical work of the pharmacy.
第二十三條
醫(yī)療機(jī)構(gòu)配制制劑，須經(jīng)所在地省、自治區(qū)、直轄市人民政府衛(wèi)生行政部門審核同意，由省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給《醫(yī)療機(jī)構(gòu)制劑許可證》。無《醫(yī)療機(jī)構(gòu)制劑許可證》的，不得配制制劑。
Article 23 To make medicinal preparations, a medical organization must be
examined and approved by the administrative departments of health of the
provinces, autonomous regions, or municipalities directly under the central
government where the organization is located , and approved and issued a
Dispensing Permit for Medical Organizations by the pharmaceutical supervisory
and administrative departments of the provinces, autonomous regions or
municipalities directly under the central government. No medicinal preparations
shall be made without a Dispensing Permit for Medical Organizations.
《醫(yī)療機(jī)構(gòu)制劑許可證》應(yīng)當(dāng)標(biāo)明有效期，到期重新審查發(fā)證。
The Dispensing Permit for Medical Organizations shall bear a period of
validity, and upon expiration a new license shall be issued after examination
for its renewal.
第二十四條 醫(yī)療機(jī)構(gòu)配制制劑，必須具有能夠保證制劑質(zhì)量的設(shè)施、管理制度、檢驗(yàn)儀器和衛(wèi)生條件。
Article 24 Medical organizations that make medicinal preparations must have
facilities, a m
第二十五條 醫(yī)療機(jī)構(gòu)配制的制劑，應(yīng)當(dāng)是本單位臨床需要而市場(chǎng)上沒有供應(yīng)的品種，并須經(jīng)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)后方可配制。
Article 25 The medicinal preparations made by medical organizations shall be
of the kinds that supply the clinical needs of the units themselves but have not
been supplied on the market, and must not be made until the approval of the
pharmaceutical supervisory and administrative departments of the provinces,
autonomous regions and municipalities directly under the central government
where the units are located.
配制的制劑必須按照規(guī)定進(jìn)行質(zhì)量檢驗(yàn)；合格的，憑醫(yī)師處方在本醫(yī)療機(jī)構(gòu)使用。特殊情況下，經(jīng)國(guó)務(wù)院或者省、自治區(qū)、直轄市人民政府的藥品監(jiān)督管理部門批準(zhǔn)，醫(yī)療機(jī)構(gòu)配制的制劑可以在指定的醫(yī)療機(jī)構(gòu)之間調(diào)劑使用。
The quality of the medicinal preparations made by medical organizations must
be inspected in accordance with relevant regulations. Those preparations
conforming to standard can be used as the doctor prescribes. Under special
circumstances, with approval from the pharmaceutical supervisory and
administrative departments of the central government or of the provinces,
autonomous regions and municipalities directly under the central government, the
medicinal preparations made by medical organizations can be shared among
appointed medical organizations.
醫(yī)療機(jī)構(gòu)配制的制劑，不得在市場(chǎng)銷售。
Medicinal preparations made by medical organizations may not be sold on the
market.
第二十六條 醫(yī)療機(jī)構(gòu)購(gòu)進(jìn)藥品，必須建立并執(zhí)行進(jìn)貨檢查驗(yàn)收制度，驗(yàn)明藥品合格證明和其他標(biāo)識(shí)；不符合規(guī)定要求的，不得購(gòu)進(jìn)和使用。
Article 26 When purchasing pharmaceuticals, medical organizations must
formulate and implement a system of quality inspection and check the
certificates and other marks of pharmaceuticals. Those pharmaceuticals that do
not meet the requirements of relevant regulations shall not be purchased and
used.
第二十七條
醫(yī)療機(jī)構(gòu)的藥劑人員調(diào)配處方，必須經(jīng)過核對(duì)，對(duì)處方所列藥品不得擅自更改或者代用。對(duì)有配伍禁忌或者超劑量的處方，應(yīng)當(dāng)拒絕調(diào)配；必要時(shí)，經(jīng)處方醫(yī)師更正或者重新簽字，方可調(diào)配。
Article 27 Prescriptions being dispensed by the dispensers of medical
organizations must be checked. Pharmaceuticals listed in prescriptions must not
be presumptuously changed or substituted. Prescriptions containing incompatible
substances or excessive dosages shall be rejected by the dispensary. If
necessary, such prescriptions can be dispensed after they have been corrected or
re-signed by the doctors who wrote them.
第二十八條 醫(yī)療機(jī)構(gòu)必須制定和執(zhí)行藥品保管制度，采取必要的冷藏、防凍、防潮、防蟲、防鼠等措施，保證藥品質(zhì)量。
Article 28 Rules for storage of pharmaceuticals shall be formulated and
implemented by medical organizations, which must adopt necessary measures to
facilitate cold storage and protection against cold, moisture, insects and
rodents to ensure the quality of pharmaceuticals.
第五章 藥品管理
Chapter V Pharmaceutical Administration
第二十九條
研制新藥，必須按照國(guó)務(wù)院藥品監(jiān)督管理部門的規(guī)定如實(shí)報(bào)送研制方法、質(zhì)量指標(biāo)、藥理及毒理試驗(yàn)結(jié)果等有關(guān)資料和樣品，經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)后，方可進(jìn)行臨床試驗(yàn)。藥物臨床試驗(yàn)機(jī)構(gòu)資格的認(rèn)定辦法，由國(guó)務(wù)院藥品監(jiān)督管理部門、國(guó)務(wù)院衛(wèi)生行政部門共同制定。
Article 29 When producing a new medicine, it is necessary to submit
information about the methods of production, quality indices, pharmacological
and toxicological testing results, and other related materials and sales as
required by the pharmaceutical supervisory and administrative department of the
State Council, only after whose approval can clinical tests be carried out.
Certifying measures for clinical test units shall be jointly formulated by the
pharmaceutical supervisory and administrative department under the State Council
and the administrative department of health under the State Council.
完成臨床試驗(yàn)并通過審批的新藥，由國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，發(fā)給新藥證書。
A new medicine which has completed its clinical tests and been approved after
appraisal shall be issued a certificate of new medicine by the pharmaceutical
supervisory and administrative department under the State Council.
第三十條 藥物的非臨床安全性評(píng)價(jià)研究機(jī)構(gòu)和臨床試驗(yàn)機(jī)構(gòu)必須分別執(zhí)行藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范。
Article 30 The pharmaceutical non-clinical safety appraisal and research units
and the clinical test units must respectively carry out the quality control
standard for pharmaceutical non-clinical research and the quality control
standard for pharmaceutical clinical test.
藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范由國(guó)務(wù)院確定的部門制定。
The quality control standard for pharmaceutical non-clinical research and the
quality control standard for pharmaceutical clinical test shall be formulated by
the department appointed by the State Council.
第三十一條 生產(chǎn)新藥或者已有國(guó)家標(biāo)準(zhǔn)的藥品的，須經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)，并發(fā)給藥品批準(zhǔn)文號(hào)；但是，生產(chǎn)沒有實(shí)施批準(zhǔn)文號(hào)管理的中藥材和中藥飲片除外。
Article 31 A new medicine or medicine standardized by the State can be put
into production only after the pharmaceutical supervisory and administrative
department under the State Council has approved it and issued a registered
document of approval. However, this does not apply to the production of
traditional Chinese medicinal herbs and traditional Chinese medicine prepared in
ready-to-use forms that are not controlled under a registered document of
approval.
實(shí)施批準(zhǔn)文號(hào)管理的中藥材、中藥飲片品種目錄由國(guó)務(wù)院藥品監(jiān)督管理部門會(huì)同國(guó)務(wù)院中醫(yī)藥管理部門制定。
For those traditional Chinese medicinal herbs and traditional Chinese
medicines prepared in ready-to-use forms that are controlled with registered
document of approval, the pharmaceutical supervisory and administrative
department under the State Council and the administrative department of
traditional Chinese medicines under the State Council shall jointly formulate
their type catalogue.
藥品生產(chǎn)企業(yè)在取得藥品批準(zhǔn)文號(hào)后，方可生產(chǎn)該藥品。
Pharmaceutical producing enterprises can produce medicine only after obtaining
the registered document of approval.
第三十二條 藥品必須符合國(guó)家藥品標(biāo)準(zhǔn)。中藥飲片依照本法第十條第二款的規(guī)定執(zhí)行。
Article 32 Pharmaceuticals must meet the pharmaceutical standards of the
State. Article 10 (2) of this Law shall be applied to traditional Chinese
medicines prepared in ready-to-use forms.
國(guó)務(wù)院藥品監(jiān)督管理部門頒布的《中華人民共和國(guó)藥典》和藥品標(biāo)準(zhǔn)為國(guó)家藥品標(biāo)準(zhǔn)。
The "Pharmacopoeia of the People's Republic of China" and the pharmaceutical
standards promulgated by the pharmaceutical supervisory and administrative
department under the State Council shall be the State pharmaceutical standards.
國(guó)務(wù)院藥品監(jiān)督管理部門組織藥典委員會(huì)，負(fù)責(zé)國(guó)家藥品標(biāo)準(zhǔn)的制定和修訂。
The Pharmacopoeia Committee organized by the pharmaceutical supervisory and
administrative department under the State Council shall be responsible for the
formulation and revision of the State pharmaceutical standards.
國(guó)務(wù)院藥品監(jiān)督管理部門的藥品檢驗(yàn)機(jī)構(gòu)負(fù)責(zé)標(biāo)定國(guó)家藥品標(biāo)準(zhǔn)品、對(duì)照品。
The pharmaceutical inspection institutions of the pharmaceutical supervisory
and administrative department under the State Council shall be responsible for
the designation of State standard and contrastive pharmaceuticals.
第三十三條 國(guó)務(wù)院藥品監(jiān)督管理部門組織藥學(xué)、醫(yī)學(xué)和其他技術(shù)人員，對(duì)新藥進(jìn)行審評(píng)，對(duì)已經(jīng)批準(zhǔn)生產(chǎn)的藥品進(jìn)行再評(píng)價(jià)。
Article 33 The pharmaceutical supervisory and administrative department under
the State Council may organize pharmaceutical, medicinal and other technological
personnel to carry out examination and evaluation of new medicines, and to
reevaluate medicines already placed into production.
第三十四條 藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu)必須從具有藥品生產(chǎn)、經(jīng)營(yíng)資格的企業(yè)購(gòu)進(jìn)藥品；但是，購(gòu)進(jìn)沒有實(shí)施批準(zhǔn)文號(hào)管理的中藥材除外。
Article 34 Pharmaceutical producing enterprises, pharmaceutical trading
enterprises and medical organizations must purchase pharmaceuticals from the
qualified enterprises with the certificates for production and trade of
pharmaceuticals. However, this does not apply to the purchase of the traditional
Chinese medicinal herbs which are not controlled under the registered document
of approval.
第三十五條 國(guó)家對(duì)麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品，實(shí)行特殊管理。管理辦法由國(guó)務(wù)院制定。
Article 35 For narcotics, psychotropic substances, toxic drugs for medicinal
use, and radioactive drugs, the State Council shall formulate administrative
measures to carry out special control.
第三十六條 國(guó)家實(shí)行中藥品種保護(hù)制度。具體辦法由國(guó)務(wù)院制定。
Article 36 The State Council shall formulate detailed measures to carry out a
protection system for the categorization of traditional Chinese medicines.
第三十七條 國(guó)家對(duì)藥品實(shí)行處方藥與非處方藥分類管理制度。具體辦法由國(guó)務(wù)院制定。
Article 37 The State Council shall formulate detailed measures to carry out a
classified control system for prescription pharmaceuticals and non-prescription
pharmaceuticals.
第三十八條 禁止進(jìn)口療效不確、不良反應(yīng)大或者其他原因危害人體健康的藥品。
Article 38 Import of medicines whose curative effects are uncertain or poor,
or which produce adverse reactions or have other harmful effects on people's
health shall be prohibited.
第三十九條 藥品進(jìn)口，須經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門組織審查，經(jīng)審查確認(rèn)符合質(zhì)量標(biāo)準(zhǔn)、安全有效的，方可批準(zhǔn)進(jìn)口，并發(fā)給進(jìn)口藥品注冊(cè)證書。
Article 39 The import of medicines must go through examinations organized by
the pharmaceutical supervisory and administrative department under the State
Council. Those confirmed to conform to quality standards to be safe and
effective can be approved to be imported and shall be issued a registered
certificate for import.
醫(yī)療單位臨床急需或者個(gè)人自用進(jìn)口的少量藥品，按照國(guó)家有關(guān)規(guī)定辦理進(jìn)口手續(xù)。
Medicines to be imported in small quantities for urgent clinical needs by
medical organizations or for personal use shall go through import formalities
according to relevant regulations of the State.
第四十條
藥品必須從允許藥品進(jìn)口的口岸進(jìn)口，并由進(jìn)口藥品的企業(yè)向口岸所在地藥品監(jiān)督管理部門登記備案。海關(guān)憑藥品監(jiān)督管理部門出具的《進(jìn)口藥品通關(guān)單》放行。無《進(jìn)口藥品通關(guān)單》的，海關(guān)不得放行。
Article 40 Pharmaceuticals must be imported through the ports which allow the
import of pharmaceuticals, and the pharmaceutical import enterprise shall submit
a report to the pharmaceutical supervisory and administrative department of the
place where the port is located. Customs shall rely on the Import
Pharmaceuticals Customs Form issued by the pharmaceutical supervisory and
administrative department to proceed. Those without the Import Pharmaceuticals
Customs Form shall not be permitted to pass through customs.
口岸所在地藥品監(jiān)督管理部門應(yīng)當(dāng)通知藥品檢驗(yàn)機(jī)構(gòu)按照國(guó)務(wù)院藥品監(jiān)督管理部門的規(guī)定對(duì)進(jìn)口藥品進(jìn)行抽查檢驗(yàn)，并依照本法第四十一條第二款的規(guī)定收取檢驗(yàn)費(fèi)。
The pharmaceutical supervisory and administrative department of the place
where the port is located shall notify the pharmaceutical inspection institution
to carry out selective examinations and inspections on the imported
pharmaceuticals according to the regulations stipulated by the pharmaceutical
supervisory and administrative department under the State Council, and to
collect inspection fees according to Article 41(2) of this Law.
允許藥品進(jìn)口的口岸由國(guó)務(wù)院藥品監(jiān)督管理部門會(huì)同海關(guān)總署提出，報(bào)國(guó)務(wù)院批準(zhǔn)。
The nomination of the ports allowable for import of pharmaceuticals shall be
jointly conducted by the pharmaceutical supervisory and administrative
department under the State Council and the Customs Headquarters, and be reported
to the State Council for approval.
第四十一條 國(guó)務(wù)院藥品監(jiān)督管理部門對(duì)下列藥品在銷售前或者進(jìn)口時(shí)，指定藥品檢驗(yàn)機(jī)構(gòu)進(jìn)行檢驗(yàn)；檢驗(yàn)不合格的，不得銷售或者進(jìn)口：
Article 41 The pharmaceutical supervisory and administrative department under
the State Council shall appoint inspection institutions to carry out inspections
before the sale and import of the following pharmaceuticals. Those having not
passed the inspection shall not be allowed to be sold or imported.
（一）國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定的生物制品；
(1) Bio-products prescribed by the pharmaceutical supervisory and
administrative department of the State Council.
?。ǘ┦状卧谥袊?guó)銷售的藥品；
(2) Pharmaceuticals to be sold for the first time in China.
?。ㄈ﹪?guó)務(wù)院規(guī)定的其他藥品。
(3) Other pharmaceuticals prescribed by the State Council.
前款所列藥品的檢驗(yàn)費(fèi)項(xiàng)目和收費(fèi)標(biāo)準(zhǔn)由國(guó)務(wù)院財(cái)政部門會(huì)同國(guó)務(wù)院價(jià)格主管部門核定并公告。
The inspection fee and charge standards for the above-mentioned
pharmaceuticals shall be jointly checked, ratified and promulgated by the
financial department under the State Council and the competent authority of
price control under the State Council.
檢驗(yàn)費(fèi)收繳辦法由國(guó)務(wù)院財(cái)政部門會(huì)同國(guó)務(wù)院藥品監(jiān)督管理部門制定。
The measures for the collection of inspection fees shall be jointly formulated
by the financial department under the State Council and the pharmaceutical
supervisory and administrative department under the State Council.
第四十二條
國(guó)務(wù)院藥品監(jiān)督管理部門對(duì)已經(jīng)批準(zhǔn)生產(chǎn)或者進(jìn)口的藥品，應(yīng)當(dāng)組織調(diào)查；對(duì)療效不確、不良反應(yīng)大或者其他原因危害人體健康的藥品，應(yīng)當(dāng)撤銷批準(zhǔn)文號(hào)或者進(jìn)口藥品注冊(cè)證書。
Article 42 The pharmaceutical supervisory and administrative department under
the State Council shall organize investigations on medicines which have been
approved for production or import. It shall revoke the registered documents of
approval or the registered certificate of import if it discovers that the
curative effects of the medicines are uncertain or poor, that they produce
serious adverse reactions, or that for other reasons they are harmful to
people's health.
已被撤銷批準(zhǔn)文號(hào)或者進(jìn)口藥品注冊(cè)證書的藥品，不得生產(chǎn)或者進(jìn)口、銷售和使用；已經(jīng)生產(chǎn)或者進(jìn)口的，由當(dāng)?shù)厮幤繁O(jiān)督管理部門監(jiān)督銷毀或者處理。
The medicines whose registered documents of approval or registered certificate
of import have been revoked shall not be allowed to be produced, imported, sold
or used. Those which have already been produced or imported shall be destroyed
or disposed of under the supervision of the local pharmaceutical supervisory and
administrative departments.
第四十三條 國(guó)家實(shí)行藥品儲(chǔ)備制度。
Article 43 A pharmaceutical reserve system shall be carried out by the State.
國(guó)內(nèi)發(fā)生重大災(zāi)情、疫情及其他突發(fā)事件時(shí)，國(guó)務(wù)院規(guī)定的部門可以緊急調(diào)用企業(yè)藥品。
In case of serious disasters, plagues and other sudden emergencies, the
department prescribed by the State Council can requisite the pharmaceuticals of
enterprises to deal with such emergencies.
第四十四條 對(duì)國(guó)內(nèi)供應(yīng)不足的藥品，國(guó)務(wù)院有權(quán)限制或者禁止出口。
Article 44 The State Council shall have the power to restrict or prohibit the
export of the pharmaceuticals which are in short supply in the domestic market.
第四十五條 進(jìn)口、出口麻醉藥品和國(guó)家規(guī)定范圍內(nèi)的精神藥品，必須持有國(guó)務(wù)院藥品監(jiān)督管理部門發(fā)給的《進(jìn)口準(zhǔn)許證》、《出口準(zhǔn)許證》。
Article 45 Import or export licenses issued by the pharmaceutical supervisory
and administrative department under the State Council are required for the
import or export of narcotics and psychotropic substances falling within the
restricted scope prescribed by the State.
第四十六條 新發(fā)現(xiàn)和從國(guó)外引種的藥材，經(jīng)國(guó)務(wù)院藥品監(jiān)督管理部門審核批準(zhǔn)后，方可銷售。
Article 46 Newly discovered domestic medicinal plants or medicinal plants
introduced from abroad may be sold only after they have been examined and
approved by the pharmaceutical supervisory and administrative department under
the State Council.
第四十七條 地區(qū)性民間習(xí)用藥材的管理辦法，由國(guó)務(wù)院藥品監(jiān)督管理部門會(huì)同國(guó)務(wù)院中醫(yī)藥管理部門制定。
Article 47 Measures for controlling medicinal materials traditionally used by
local people in certain regions shall be jointly formulated by the
pharmaceutical supervisory and administrative department under the State Council
and the administrative department of traditional Chinese medicines under the
State Council.
第四十八條 禁止生產(chǎn)（包括配制，下同）、銷售假藥。有下列情形之一的，為假藥：
Article 48 The production (including preparation, which also applies to the
following) and sale of fake medicines are prohibited. A fake medicine has any
one of the following characteristics:
?。ㄒ唬┧幤匪煞菖c國(guó)家藥品標(biāo)準(zhǔn)規(guī)定的成份不符的；
(1) Its components are different from those prescribed by state pharmaceutical
standards.
?。ǘ┮苑撬幤访俺渌幤坊蛞运N藥品冒充此種藥品的。
(2) A non-medical substance is passed off as a medicine, or one medicine is
passed off as another.
有下列情形之一的藥品，按假藥論處：
A medicine shall be handled as fake medicine in any of the following cases:
?。ㄒ唬﹪?guó)務(wù)院藥品監(jiān)督管理部門規(guī)定禁止使用的；
(1) Where the use of the medicine has been prohibited by the pharmaceutical
supervisory and administrative department under the State Council;
?。ǘ┮勒毡痉ū仨毰鷾?zhǔn)而未經(jīng)批準(zhǔn)生產(chǎn)、進(jìn)口，或者依照本法必須檢驗(yàn)而未經(jīng)檢驗(yàn)即銷售的；
(2) Where the medicine is produced and imported without an approval dictated
according to this Law, or the medicine is sold without being inspected as
dictated according to this Law;
?。ㄈ┳冑|(zhì)的；
(3) Where the medicine has deteriorated; or
?。ㄋ模┍晃廴镜?；
(4) Where the medicine has been contaminated;
（五）使用依照本法必須取得批準(zhǔn)文號(hào)而未取得批準(zhǔn)文號(hào)的原料藥生產(chǎn)的；
(5) Where the medicine has been produced with pharmaceutical materials without
obtaining the dictated registration document of approval for the materials.
?。┧鶚?biāo)明的適應(yīng)癥或者功能主治超出規(guī)定范圍的。
(6) Where the indications or the functions marked on the labels of the
pharmaceuticals do not fall within the prescribed scope.
第四十九條 禁止生產(chǎn)、銷售劣藥。藥品成份的含量不符合國(guó)家藥品標(biāo)準(zhǔn)的，為劣藥。
Article 49 It is prohibited to produce and sell medicines of inferior quality,
referring to the medicines whose components do not conform in quantity to that
required by State pharmaceutical standards.
有下列情形之一的藥品，按劣藥論處：
A medicine shall be handled as medicine of inferior quality in any of the
following cases:
（一）未標(biāo)明有效期或者更改有效期的；
(1) An expiry date is not indicated or is altered; or
?。ǘ┎蛔⒚骰蛘吒纳a(chǎn)批號(hào)的；
(2) A registration number is not indicated or is altered; or
?。ㄈ┏^有效期的；
(3) The medicine has passed its expiration date; or
（四）直接接觸藥品的包裝材料和容器未經(jīng)批準(zhǔn)的；
(4) The packages and containers which have direct contact with pharmaceuticals
have not obtained approval; or
?。ㄎ澹┥米蕴砑又珓?、防腐劑、香料、矯味劑及輔料的；
(5) The medicine has been added presumptuously with color or preservative
additives, spice, disguising odor or supplementary materials; or
?。┢渌环纤幤窐?biāo)準(zhǔn)規(guī)定的。
(6) The medicine fails to meet the prescribed standards in other respects.
第五十條 列入國(guó)家藥品標(biāo)準(zhǔn)的藥品名稱為藥品通用名稱。已經(jīng)作為藥品通用名稱的，該名稱不得作為藥品商標(biāo)使用。
Article 50 The names of the pharmaceuticals listed in the State pharmaceutical
standards are the generic names of the pharmaceuticals. Those names that have
become the generic names of pharmaceuticals shall not be used as trademarks of
pharmaceuticals.
第五十一條
藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)直接接觸藥品的工作人員，必須每年進(jìn)行健康檢查?；加袀魅静』蛘咂渌赡芪廴舅幤返募膊〉?，不得從事直接接觸藥品的工作。
Article 51 Personnel in pharmaceutical producing or trading enterprises and in
medical organizations who have direct contact with medicines must undergo an
annual medical examination. Persons who have contracted contagious diseases or
any other disease which may contaminate the medicine shall not be allowed to
engage in any work which has direct contact with pharmaceuticals.
第六章 藥品包裝的管理
Chapter VI Administration on Pharmaceutical Packaging
第五十二條 直接接觸藥品的包裝材料和容器，必須符合藥用要求，符合保障人體健康、安全的標(biāo)準(zhǔn)，并由藥品監(jiān)督管理部門在審批藥品時(shí)一并審批。
Article 52 The pharmaceutical packaging materials and containers which have
direct contact with pharmaceuticals must meet the requirements of medicinal use,
conform with the standards of protecting people's health and safety, and obtain
the approval of the pharmaceutical supervisory and administrative departments at
the same time as the approval of the pharmaceutical product.
藥品生產(chǎn)企業(yè)不得使用未經(jīng)批準(zhǔn)的直接接觸藥品的包裝材料和容器。
Pharmaceutical producing enterprises shall use the packaging materials and
containers which have direct contact with the pharmaceuticals only after they
have obtained approval for them.
對(duì)不合格的直接接觸藥品的包裝材料和容器，由藥品監(jiān)督管理部門責(zé)令停止使用。
The pharmaceutical supervisory and administrative departments shall stop the
use of those unqualified packaging materials and containers which have direct
contact with the pharmaceuticals.
第五十三條 藥品包裝必須適合藥品質(zhì)量的要求，方便儲(chǔ)存、運(yùn)輸和醫(yī)療使用。
Article 53 Packaging must meet the specific quality requirements of the
pharmaceuticals and facilitate their storage, transportation and medical use.
發(fā)運(yùn)中藥材必須有包裝。在每件包裝上，必須注明品名、產(chǎn)地、日期、調(diào)出單位，并附有質(zhì)量合格的標(biāo)志。
Traditional Chinese medicinal materials must be packaged before
transportation. There must appear on the package the name of the medicine, place
of production, date, name of the consignor, and an indication showing that the
quality of the medicine meets standards.
第五十四條 藥品包裝必須按照規(guī)定印有或者貼有標(biāo)簽并附有說明書。
Article 54 Packages of pharmaceuticals must be labeled and include directions
for use in accordance with the regulations.
標(biāo)簽或者說明書上必須注明藥品的通用名稱、成份、規(guī)格、生產(chǎn)企業(yè)、批準(zhǔn)文號(hào)、產(chǎn)品批號(hào)、生產(chǎn)日期、有效期、適應(yīng)癥或者功能主治、用法、用量、禁忌、不良反應(yīng)和注意事項(xiàng)。
The label or directions must indicate the generic name of the medicine,
components, specifications, the producer, registration number, batch number of
the product, production date, expiry date, indications or major functions,
directions for use, dosage, restrictions, adverse reactions and precautions.
麻醉藥品、精神藥品、醫(yī)療用毒性藥品、放射性藥品、外用藥品和非處方藥的標(biāo)簽，必須印有規(guī)定的標(biāo)志。
Special indications must be printed as required on the labels of narcotics,
psychotropic substances, toxic drugs for medical use, radioactive drugs,
medicines for external use and non-prescriptive pharmaceuticals.
第七章 藥品價(jià)格和廣告的管理
Chapter VII Administration of the Prices and Advertising of Pharmaceuticals
第五十五條
依法實(shí)行政府定價(jià)、政府指導(dǎo)價(jià)的藥品，政府價(jià)格主管部門應(yīng)當(dāng)依照《中華人民共和國(guó)價(jià)格法》規(guī)定的定價(jià)原則，依據(jù)社會(huì)平均成本、市場(chǎng)供求狀況和社會(huì)承受能力合理制定和調(diào)整價(jià)格，做到質(zhì)價(jià)相符，消除虛高價(jià)格，保護(hù)用藥者的正當(dāng)利益。
Article 55 For pharmaceuticals controlled by the fixed and directive pricing
system of the government, the competent authority of pricing of the government
shall fix and adjust the price with reason in conformity with the principles for
fixing prices as prescribed by the Price Law of the PRC and according to the
considerations of societal average costs, market supply and demand, and the
level of societal tolerance to achieve accord between quality and price, to
avoid excessive prices, and to safeguard the due interests of the users of the
pharmaceuticals.
藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)必須執(zhí)行政府定價(jià)、政府指導(dǎo)價(jià)，不得以任何形式擅自提高價(jià)格。
Pharmaceutical producing enterprises, trading enterprises and medical
organizations must carry out the fixed price and directive price system of the
government, and shall not presumptuously raise prices in any form.
藥品生產(chǎn)企業(yè)應(yīng)當(dāng)依法向政府價(jià)格主管部門如實(shí)提供藥品的生產(chǎn)經(jīng)營(yíng)成本，不得拒報(bào)、虛報(bào)、瞞報(bào)。
Pharmaceutical producing enterprises shall provide the competent authority of
pricing of the government with the producing and trading costs of
pharmaceuticals and shall not refuse to report, make a false report or withhold
the truth in such a report.
第五十六條 依法實(shí)行市場(chǎng)調(diào)節(jié)價(jià)的藥品，藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)應(yīng)當(dāng)按照公平、合理和誠(chéng)實(shí)信用、質(zhì)價(jià)相符的原則制定價(jià)格，為用藥者提供價(jià)格合理的藥品。
Article 56 For the pharmaceuticals whose prices are to be adjusted by the
market, the pharmaceutical producing enterprises, trading enterprises, and
medical organizations shall fix the price in conformity with the principles of
fairness, rationality, honesty, good faith and accord between quality and price
to provide the users of the pharmaceuticals with reasonable prices.
藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)應(yīng)當(dāng)遵守國(guó)務(wù)院價(jià)格主管部門關(guān)于藥價(jià)管理的規(guī)定，制定和標(biāo)明藥品零售價(jià)格，禁止暴利和損害用藥者利益的價(jià)格欺詐行為。
Pharmaceutical producing enterprises, trading enterprises and medical
organizations shall abide by the regulations concerning the control on prices of
pharmaceuticals prescribed by the competent authority of pricing under the State
Council, shall fix and mark the retail prices of pharmaceuticals, and shall
avoid sudden excessive profits and deceptive acts on pricing which will harm the
interests of the users of the pharmaceuticals.
第五十七條 藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu)應(yīng)當(dāng)依法向政府價(jià)格主管部門提供其藥品的實(shí)際購(gòu)銷價(jià)格和購(gòu)銷數(shù)量等資料。
Article 57 Pharmaceutical producing enterprises, trading enterprises and
medical organizations shall, in accordance with this Law, provide the competent
authority of pricing of the government with information such as the actual
purchasing and selling prices and quantities of the pharmaceuticals.
第五十八條
醫(yī)療機(jī)構(gòu)應(yīng)當(dāng)向患者提供所用藥品的價(jià)格清單；醫(yī)療保險(xiǎn)定點(diǎn)醫(yī)療機(jī)構(gòu)還應(yīng)當(dāng)按照規(guī)定的辦法如實(shí)公布其常用藥品的價(jià)格，加強(qiáng)合理用藥的管理。具體辦法由國(guó)務(wù)院衛(wèi)生行政部門規(guī)定。
Article 58 Medical organizations shall provide the patient with the price list
of the pharmaceuticals used. Medical organizations appointed by medical
insurance shall faithfully promulgate the prices of frequently used
pharmaceuticals according to prescribed measures to enhance the reasonable use
of pharmaceuticals.
第五十九條 禁止藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)在藥品購(gòu)銷中帳外暗中給予、收受回扣或者其他利益。
Article 59 Pharmaceutical producing enterprises, trading enterprises and
medical organizations are prohibited to give or receive secret commissions and
other benefits during the purchasing and selling of pharmaceuticals.
禁止藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)或者其代理人以任何名義給予使用其藥品的醫(yī)療機(jī)構(gòu)的負(fù)責(zé)人、藥品采購(gòu)人員、醫(yī)師等有關(guān)人員以財(cái)物或者其他利益。禁止醫(yī)療機(jī)構(gòu)的負(fù)責(zé)人、藥品采購(gòu)人員、醫(yī)師等有關(guān)人員以任何名義收受藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)或者其代理人給予的財(cái)物或者其他利益。
Pharmaceutical producing enterprises, trading enterprises or their
representatives are prohibited to give any property or other benefits under any
name to the principals, buyers of pharmaceuticals, physicians and other relevant
persons in the medical organizations where their pharmaceuticals are used. The
principals, buyers of pharmaceuticals, physicians and other relevant persons are
prohibited from receiving any property or other benefits under any name from
pharmaceutical producing enterprises, trading enterprises or their agents.
第六十條 藥品廣告須經(jīng)企業(yè)所在地省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門批準(zhǔn)，并發(fā)給藥品廣告批準(zhǔn)文號(hào)；
Article 60 Advertisements of pharmaceuticals must be approved and issued a
registration number of advertisement by the pharmaceutical supervisory and
administrative departments of the provinces, autonomous regions, or
municipalities directly under the central government of the place where the
enterprises are located.
未取得藥品廣告批準(zhǔn)文號(hào)的，不得發(fā)布。
In the absence of such registration numbers, advertisements for any medicines
may not be placed.
處方藥可以在國(guó)務(wù)院衛(wèi)生行政部門和國(guó)務(wù)院藥品監(jiān)督管理部門共同指定的醫(yī)學(xué)、藥學(xué)專業(yè)刊物上介紹，但不得在大眾傳播媒介發(fā)布廣告或者以其他方式進(jìn)行以公眾為對(duì)象的廣告宣傳。
Prescription pharmaceuticals may be introduced in medicinal and pharmaceutical
magazines jointly appointed by the administrative department of health under the
State Council and the pharmaceutical supervisory and administrative department
under the State Council, but shall not be advertised through mass media or
publicized in any other form to the public.
第六十一條 藥品廣告的內(nèi)容必須真實(shí)、合法，以國(guó)務(wù)院藥品監(jiān)督管理部門批準(zhǔn)的說明書為準(zhǔn)，不得含有虛假的內(nèi)容。
Article 61 The contents of pharmaceutical advertisement must be true,
legitimate, and be based on the directions for use approved by the
pharmaceutical supervisory and administrative department under the State
Council, and be also free of falsehood.
藥品廣告不得含有不科學(xué)的表示功效的斷言或者保證；不得利用國(guó)家機(jī)關(guān)、醫(yī)藥科研單位、學(xué)術(shù)機(jī)構(gòu)或者專家、學(xué)者、醫(yī)師、患者的名義和形象作證明。
Advertisements of pharmaceuticals shall not contain any unscientific assertion
or guarantee on effects, and shall not be endorsed using the names and images of
government bodies, pharmaceutical scientific research units, academic
organizations, experts, scholars, physicians and sufferers.
非藥品廣告不得有涉及藥品的宣傳。
The advertisements of non-pharmaceuticals shall not be involved in the
publicizing of pharmaceuticals.
第六十二條
省、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門應(yīng)當(dāng)對(duì)其批準(zhǔn)的藥品廣告進(jìn)行檢查，對(duì)于違反本法和《中華人民共和國(guó)廣告法》的廣告，應(yīng)當(dāng)向廣告監(jiān)督管理機(jī)關(guān)通報(bào)并提出處理建議，廣告監(jiān)督管理機(jī)關(guān)應(yīng)當(dāng)依法作出處理。
Article 62 The pharmaceutical supervisory and administrative departments of
the provinces, autonomous regions and municipalities directly under the central
government shall inspect on the pharmaceutical advertisements they approve, and
shall notify and advise the administrative departments of advertising if the
advertisements is not in conformity with this Law and the Advertisement Law of
the PRC. The administrative departments of advertising shall deal with such
advertisements according to relevant regulations.
第六十三條 藥品價(jià)格和廣告，本法未規(guī)定的，適用《中華人民共和國(guó)價(jià)格法》、《中華人民共和國(guó)廣告法》的規(guī)定。
Article 63 In the absence of regulations as provided in this Law, the Price
Law of the PRC and the Advertisement Law of the PRC shall be applied to the
control of pharmaceutical prices and advertisements.
第八章 藥品監(jiān)督
Chapter VIII Supervision over Pharmaceuticals
第六十四條
藥品監(jiān)督管理部門有權(quán)按照法律、行政法規(guī)的規(guī)定對(duì)報(bào)經(jīng)其審批的藥品研制和藥品的生產(chǎn)、經(jīng)營(yíng)以及醫(yī)療機(jī)構(gòu)使用藥品的事項(xiàng)進(jìn)行監(jiān)督檢查，有關(guān)單位和個(gè)人不得拒絕和隱瞞。
Article 64 Pharmaceutical supervisory and administrative departments are
authorized to conduct, in accordance with laws and administrative regulations,
supervision and inspection over the research,development, production and trade
of pharmaceuticals which they have approved, as well as the medical
organizations' use of pharmaceuticals. The units and individuals concerned shall
not refuse to comply.
藥品監(jiān)督管理部門進(jìn)行監(jiān)督檢查時(shí)，必須出示證明文件，對(duì)監(jiān)督檢查中知悉的被檢查人的技術(shù)秘密和業(yè)務(wù)秘密應(yīng)當(dāng)保密。
Pharmaceutical supervisory and administrative departments shall present
certificate documents while conducting supervision and inspection, and shall not
divulge technological and business.
第六十五條 藥品監(jiān)督管理部門根據(jù)監(jiān)督檢查的需要，可以對(duì)藥品質(zhì)量進(jìn)行抽查檢驗(yàn)。抽查檢驗(yàn)應(yīng)當(dāng)按照規(guī)定抽樣，并不得收取任何費(fèi)用。所需費(fèi)用按照國(guó)務(wù)院規(guī)定列支。
Article 65 According to the needs of supervision and inspection,
pharmaceutical supervisory and administrative departments may conduct sampling
examinations on the quality of pharmaceuticals. The sampling examinations shall
be conducted according to relevant regulations and shall not be charged a fee.
The expenses incurred shall be dispensed with in conformity with the regulations
prescribed by the State Council.
藥品監(jiān)督管理部門對(duì)有證據(jù)證明可能危害人體健康的藥品及其有關(guān)材料可以采取查封、扣押的行政強(qiáng)制措施，并在七日內(nèi)作出行政處理決定；藥品需要檢驗(yàn)的，必須自檢驗(yàn)報(bào)告書發(fā)出之日起十五日內(nèi)作出行政處理決定。
Pharmaceutical supervisory and administrative departments may take
administrative coercive measures including sequestration and banning against
pharmaceuticals and other relevant materials which have been proven to be of
possible harm to people's health; administrative measures must be taken within
seven days. For pharmaceuticals which need to be inspected, decisions regarding
administrative handling must be made within 15 days from the date of issue of
the inspection reports.
第六十六條 國(guó)務(wù)院和省、自治區(qū)、直轄市人民政府的藥品監(jiān)督管理部門應(yīng)當(dāng)定期公告藥品質(zhì)量抽查檢驗(yàn)的結(jié)果；公告不當(dāng)?shù)?，必須在原公告范圍?nèi)予以更正。
Article 66 The pharmaceutical supervisory and administrative departments under
the State Council and of the provinces, autonomous regions and municipalities
directly under the central government shall regularly promulgate the results of
sampling examinations and inspections on the quality of pharmaceuticals, and
shall, in the case of improperly published statements, amend such statements in
the original published documents.
第六十七條
當(dāng)事人對(duì)藥品檢驗(yàn)機(jī)構(gòu)的檢驗(yàn)結(jié)果有異議的，可以自收到藥品檢驗(yàn)結(jié)果之日起七日內(nèi)向原藥品檢驗(yàn)機(jī)構(gòu)或者上一級(jí)藥品監(jiān)督管理部門設(shè)置或者確定的藥品檢驗(yàn)機(jī)構(gòu)申請(qǐng)復(fù)驗(yàn)，也可以直接向國(guó)務(wù)院藥品監(jiān)督管理部門設(shè)置或者確定的藥品檢驗(yàn)機(jī)構(gòu)申請(qǐng)復(fù)驗(yàn)。受理復(fù)驗(yàn)的藥品檢驗(yàn)機(jī)構(gòu)必須在國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定的時(shí)間內(nèi)作出復(fù)驗(yàn)結(jié)論。
Article 67 If a party concerned disagrees with the inspection decision made by
the inspection institutions, it may apply for re-inspection to the original
inspection institutions or ones established or appointed by the pharmaceutical
supervisory and administrative departments of superior levels within seven days
from the date of receiving the pharmaceutical inspection decision, and may
directly apply for re-inspection to the inspection institutions established or
appointed by the pharmaceutical supervisory and administrative department under
the State Council. The inspection institutions which have accepted the
re-inspections shall conclude the re-inspections within the time limit
prescribed by the pharmaceutical supervisory and administrative department under
the State Council.
第六十八條
藥品監(jiān)督管理部門應(yīng)當(dāng)按照規(guī)定，依據(jù)《藥品生產(chǎn)質(zhì)量管理規(guī)范》、《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》，對(duì)經(jīng)其認(rèn)證合格的藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)進(jìn)行認(rèn)證后的跟蹤檢查。
rticle 68 Pharmaceutical supervisory and administrative departments shall
follow up on the inspections of the pharmaceutical producing enterprises or
pharmaceutical trading enterprises which they have certified in conformity with
the "Quality Control Standard of Pharmaceutical Production" and the "Quality
Control Standard of Pharmaceutical Trade."
第六十九條 地方人民政府和藥品監(jiān)督管理部門不得以要求實(shí)施藥品檢驗(yàn)、審批等手段限制或者排斥非本地區(qū)藥品生產(chǎn)企業(yè)依照本法規(guī)定生產(chǎn)的藥品進(jìn)入本地區(qū)。
Article 69 The local people's governments and pharmaceutical supervisory and
administrative departments shall not restrict or exclude the entrance of
pharmaceuticals produced according to this Law by pharmaceutical producing
enterprises in other regions of the country through the excuse of conducting
inspection , examination and approval of the pharmaceuticals.
第七十條 藥品監(jiān)督管理部門及其設(shè)置的藥品檢驗(yàn)機(jī)構(gòu)和確定的專業(yè)從事藥品檢驗(yàn)的機(jī)構(gòu)不得參與藥品生產(chǎn)經(jīng)營(yíng)活動(dòng)，不得以其名義推薦或者監(jiān)制、監(jiān)銷藥品。
Article 70 Pharmaceutical supervisory and administrative departments and the
pharmaceutical inspection institutions they have established, as well as the
institutions exclusively engaged in pharmaceutical inspection they have
appointed, shall not participate in pharmaceutical production and trade, and
shall not endorse or supervise the production and sale of pharmaceuticals in
their own names.
藥品監(jiān)督管理部門及其設(shè)置的藥品檢驗(yàn)機(jī)構(gòu)和確定的專業(yè)從事藥品檢驗(yàn)的機(jī)構(gòu)的工作人員不得參與藥品生產(chǎn)經(jīng)營(yíng)活動(dòng)。
The functionaries of pharmaceutical supervisory and administrative
departments, of the pharmaceutical inspection institutions they established, and
of the institutions exclusively engaged in the inspection of pharmaceuticals
they appointed, shall not participate in pharmaceutical production and trade.
第七十一條 國(guó)家實(shí)行藥品不良反應(yīng)報(bào)告制度。藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)必須經(jīng)?？疾毂締挝凰a(chǎn)、經(jīng)營(yíng)、使用的藥品質(zhì)量、療效和反應(yīng)。
Article 71 A reporting system over any adverse reactions of pharmaceuticals
shall be practiced by Sstate. Pharmaceutical producing enterprises,
pharmaceutical trading enterprises, and medical institutions shall conduct
regular surveys on the quality, curative effects and adverse reactions of the
pharmaceuticals they have produced, traded or used.
發(fā)現(xiàn)可能與用藥有關(guān)的嚴(yán)重不良反應(yīng)，必須及時(shí)向當(dāng)?shù)厥?、自治區(qū)、直轄市人民政府藥品監(jiān)督管理部門和衛(wèi)生行政部門報(bào)告。具體辦法由國(guó)務(wù)院藥品監(jiān)督管理部門會(huì)同國(guó)務(wù)院衛(wèi)生行政部門制定。
When serious adverse reactions possibly related to the use of the
pharmaceuticals are discovered, they must be promptly reported to the
pharmaceutical supervisory and administrative departments and the administrative
departments of health of the provinces, autonomous regions and municipalities
directly under the central government. Detailed measures shall be formulated
jointly by the pharmaceutical supervisory and administrative department under
the State Council and the administrative department of health under the State
Council.
對(duì)已確認(rèn)發(fā)生嚴(yán)重不良反應(yīng)的藥品，國(guó)務(wù)院或者省、自治區(qū)、直轄市人民政府的藥品監(jiān)督管理部門可以采取停止生產(chǎn)、銷售、使用的緊急控制措施，并應(yīng)當(dāng)在五日內(nèi)組織鑒定，自鑒定結(jié)論作出之日起十五日內(nèi)依法作出行政處理決定。
Regarding the pharmaceuticals which have been confirmed to cause serious
adverse reactions, the pharmaceutical supervisory and administrative department
under the State Council and of the provinces, autonomous regions and
municipalities directly under the central government, shall take urgent control
measures including the cessation of the production, sale, and use of the
pharmaceuticals, shall organize appraisals within five days, and shall make
decisions on their administrative handling within 15 days from the conclusion
date of the appraisals.
第七十二條 藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)和醫(yī)療機(jī)構(gòu)的藥品檢驗(yàn)機(jī)構(gòu)或者人員，應(yīng)當(dāng)接受當(dāng)?shù)厮幤繁O(jiān)督管理部門設(shè)置的藥品檢驗(yàn)機(jī)構(gòu)的業(yè)務(wù)指導(dǎo)。
Article 72 The organs or personnel in charge of pharmaceutical inspection in
pharmaceutical producing enterprises, pharmaceutical trading enterprises and
medical organizations shall receive operational guidance from the pharmaceutical
inspection institutions established by local pharmaceutical supervisory and
administrative departments.
第九章 法律責(zé)任
CHAPTER IX Legal Responsibility
第七十三條
未取得《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》生產(chǎn)藥品、經(jīng)營(yíng)藥品的，依法予以取締，沒收違法生產(chǎn)、銷售的藥品和違法所得，并處違法生產(chǎn)、銷售的藥品（包括已售出的和未售出的藥品，下同）貨值金額二倍以上五倍以下的罰款；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 73 Those who produce or trade in medicines without obtaining a
Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing
Permit of Medical Organizations, shall be placed under ban, have the unlawfully
produced and sold medicines and any unlawful income confiscated, and may
concurrently be fined a sum of money more than two but less than five times the
value of the medicines unlawfully made or sold (including both sold and unsold
pharmaceuticals, which also applies below). Those whose acts constitute a crime
shall be investigated for criminal liabilities.
第七十四條
生產(chǎn)、銷售假藥的，沒收違法生產(chǎn)、銷售的藥品和違法所得，并處違法生產(chǎn)、銷售藥品貨值金額二倍以上五倍以下的罰款；有藥品批準(zhǔn)證明文件的予以撤銷，并責(zé)令停產(chǎn)、停業(yè)整頓；情節(jié)嚴(yán)重的，吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 74 Those who produce and sell fake medicines shall have his unlawfully
produced or sold medicines and any unlawful income confiscated, and concurrently
be fined a sum of money more than two but less than five times the value value
of the medicines unlawfully produced and sold. Those who have an approval
certificate of pharmaceuticals shall have the certificate revokeded, and be
ordered to suspend production or business operations pending rectification; if
the circumstances are serious, the party shall have Pharmaceutical Production
License, or Pharmaceutical Trade License or Dispensing Permit of Medical
Organizations revoked. Those whose acts constitute a
第七十五條
生產(chǎn)、銷售劣藥的，沒收違法生產(chǎn)、銷售的藥品和違法所得，并處違法生產(chǎn)、銷售藥品貨值金額一倍以上三倍以下的罰款；情節(jié)嚴(yán)重的，責(zé)令停產(chǎn)、停業(yè)整頓或者撤銷藥品批準(zhǔn)證明文件、吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 75 Those who produce and sell medicines of inferior quality shall have
his unlawfully made and sold medicines and any unlawful income confiscated, and
be concurrently fined the sum of money more than two but less than three times
the value of the medicines unlawfully made or sold; if the circumstances are
serious, the party shall be ordered to suspend production or business pending
rectification, or have thepharmaceutical approval certificate revoked and his
Pharmaceutical Production License, or Pharmaceutical Trade License or Dispensing
Permit of Medical Organizations revoked. Those whose acts constitute a crime
will be investigated for criminal liabilities.
第七十六條 從事生產(chǎn)、銷售假藥及生產(chǎn)、銷售劣藥情節(jié)嚴(yán)重的企業(yè)或者其他單位，其直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員十年內(nèi)不得從事藥品生產(chǎn)、經(jīng)營(yíng)活動(dòng)。
Article 76 The person-in-charge or personnel directly liable in the enterprise
or other unit which produces and sells fake medicines or produces and sells
pharmaceuticals of inferior quality shall not be permitted to engage in the
production and trade of pharmaceuticals for ten years, if the circumstances are
serious.
對(duì)生產(chǎn)者專門用于生產(chǎn)假藥、劣藥的原輔材料、包裝材料、生產(chǎn)設(shè)備，予以沒收。
The producers' supplementary materials, packaging materials and production
equipment which are used exclusively for producing fake medicines and medicines
of inferior quality shall be confiscated.
第七十七條
知道或者應(yīng)當(dāng)知道屬于假劣藥品而為其提供運(yùn)輸、保管、倉(cāng)儲(chǔ)等便利條件的，沒收全部運(yùn)輸、保管、倉(cāng)儲(chǔ)的收入，并處違法收入百分之五十以上三倍以下的罰款；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 77 Those who provide facilities including transportation, preservation
and storage that have been or should have been aware of the fakery or inferior
quality of the pharmaceuticals, shall have the entirety of his income from such
transportation, preservation and storage confiscated, and concurrently be fined
a sum of money more than 50% but less than three times the value of the unlawful
income. Those whose acts constitute a crime shall be investigated for criminal
liabilities.
第七十八條
對(duì)假藥、劣藥的處罰通知，必須載明藥品檢驗(yàn)機(jī)構(gòu)的質(zhì)量檢驗(yàn)結(jié)果；但是，本法第四十八條第三款第（一）、（二）、（五）、（六）項(xiàng)和第四十九條第三款規(guī)定的情形除外。
Article 78 The notice of penalties on fake medicines and medicines of inferior
quality shall indicate the inspection results of the inspection institution.
However, this does not apply to the circumstances prescribed by Article
48(3)(a)(b)(e)(f) and Article 49 (3) of this Law.
第七十九條
藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)、藥物非臨床安全性評(píng)價(jià)研究機(jī)構(gòu)、藥物臨床試驗(yàn)機(jī)構(gòu)未按照規(guī)定實(shí)施《藥品生產(chǎn)質(zhì)量管理規(guī)范》、《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》、藥物非臨床研究質(zhì)量管理規(guī)范、藥物臨床試驗(yàn)質(zhì)量管理規(guī)范的，給予警告，責(zé)令限期改正；逾期不改正的，責(zé)令停產(chǎn)、停業(yè)整頓，并處五千元以上二萬元以下的罰款；情節(jié)嚴(yán)重的，吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》和藥物臨床試驗(yàn)機(jī)構(gòu)的資格。
Article 79 Pharmaceutical producing enterprises, trading enterprises,
pharmaceutical non-clinical safety appraisal research institution, and
pharmaceutical clinical testing institutions, shall be served a warning and be
ordered to amend themselves within a prescribed time limit if they do not carry
out the stipulations of the "Quality Control Standard of Pharmaceutical
Production," the "Quality Control Standard of Pharmaceutical Trade," the quality
control standard of pharmaceutical non-clinical research, and the quality
control standard of pharmaceutical clinical testing. Those who do not rectify
their mistakes within the prescribed time limit shall be ordered to suspend
production and business operations pending rectification, and be concurrently
fined more than 5000 but less than 20,000 RMB. If the circumstances are serious,
they shall have their Pharmaceutical Production License, Pharmaceutical Trading
License or Dispensing Permit of Medical Organizations revoked.
第八十條
藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)或者醫(yī)療機(jī)構(gòu)違反本法第三十四條的規(guī)定，從無《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》的企業(yè)購(gòu)進(jìn)藥品的，責(zé)令改正，沒收違法購(gòu)進(jìn)的藥品，并處違法購(gòu)進(jìn)藥品貨值金額二倍以上五倍以下的罰款；有違法所得的，沒收違法所得；情節(jié)嚴(yán)重的，吊銷《藥品生產(chǎn)許可證、《藥品經(jīng)營(yíng)許可證》或者醫(yī)療機(jī)構(gòu)執(zhí)業(yè)許可證書。
Article 80 If any pharmaceutical producing enterprises, pharmaceutical trading
enterprises or medical organizations violate Article 34 of this Law and purchase
medicines from enterprises without the Pharmaceutical Production License or
Pharmaceutical Trade License, they shall be ordered to amend themselves, have
their unlawfully purchased medicines confiscated, and be concurrently fined the
sum of money more than two but less than five times the value of the unlawfully
purchased medicines. If they have obtained any unlawful income, the unlawful
income shall be confiscated; if the circumstances are serious, their
Pharmaceutical Production License, Pharmaceutical Trading License or Practicing
Permit of Medical Organizations shall be revoked.
第八十一條
進(jìn)口已獲得藥品進(jìn)口注冊(cè)證書的藥品，未按照本法規(guī)定向允許藥品進(jìn)口的口岸所在地的藥品監(jiān)督管理部門登記備案的，給予警告，責(zé)令限期改正；逾期不改正的，撤銷進(jìn)口藥品注冊(cè)證書。
Article 81 Those who import pharmaceuticals with a pharmaceutical import
registration document and fail to register according to this Law at the
pharmaceutical supervisory and administrative department at the location of the
port allowed for pharmaceutical import, shall be served a warning and be ordered
to correct its mistakes within a prescribed time limit. Those who have not
corrected its mistakes within the prescribed time limit shall have their
registration document to import pharmaceuticals revoked.
第八十二條
偽造、變?cè)?、買賣、出租、出借許可證或者藥品批準(zhǔn)證明文件的，沒收違法所得，并處違法所得一倍以上三倍以下的罰款；沒有違法所得的，處二萬元以上十萬元以下的罰款；情節(jié)嚴(yán)重的，并吊銷賣方、出租方、出借方的《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》、《醫(yī)療機(jī)構(gòu)制劑許可證》或者撤銷藥品批準(zhǔn)證明文件；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 82 Those who forge, alter, trade, lease or lend licenses or
pharmaceutical approval certificates, shall have their unlawful income
confiscated and be concurrently fined the sum of money more than two but less
than three times the amount of the unlawful income. If the party has not
obtained unlawful income yet, it will be fined more than 20,000 but less than
100,000 RMB; if the circumstances are serious, the Pharmaceutical Production
License, Pharmaceutical trading License or Dispensing Permit of Medical
Organizations of the seller, lessor or lender shall be revoked, or the
pharmaceutical approval certificate shall be recalled. Those whose acts
constitute a crime shall be investigated for criminal liabilities.
第八十三條
違反本法規(guī)定，提供虛假的證明、文件資料樣品或者采取其他欺騙手段取得《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》、《醫(yī)療機(jī)構(gòu)制劑許可證》或者藥品批準(zhǔn)證明文件的，吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》、《醫(yī)療機(jī)構(gòu)制劑許可證》或者撤銷藥品批準(zhǔn)證明文件，五年內(nèi)不受理其申請(qǐng)，并處一萬元以上三萬元以下的罰款。
Article 83 Those who violate this Law by providing false certificates or
samples of documents, or obtaining the Pharmaceutical Production License, the
Pharmaceutical Trading License, the Dispensing Permit of Medical Organizations
or pharmaceutical approval certificates through cheating, shall have their
Pharmaceutical Production License, Pharmaceutical Trade License, or Dispensing
Permit of Medical Organizations revoked, have their pharmaceutical approval
certificates revoked, have their application rejected for five years, and have a
concurrent fine of more than 10,000 but less than 30,000 RMB be imposed upon
them.
第八十四條 醫(yī)療機(jī)構(gòu)將其配制的制劑在市場(chǎng)銷售的，責(zé)令改正，沒收違法銷售的制劑，并處違法銷售制劑貨值金額一倍以上三倍以下的罰款；有違法所得的，沒收違法所得。
Article 84 If a medical organization sells its preparations on the market, it
shall be ordered to correct its mistakes, have its unlawfully sold preparations
confiscated and concurrently be fined a sum of money more than two but less than
three times the value of the unlawfully sold preparations. If it has obtained
any unlawful income, the unlawful income shall be confiscated.
第八十五條 藥品經(jīng)營(yíng)企業(yè)違反本法第十八條、第十九條規(guī)定的，責(zé)令改正，給予警告；情節(jié)嚴(yán)重的，吊銷《藥品經(jīng)營(yíng)許可證》。
Article 85 If a pharmaceutical trading enterprise violates Article 18 and
Article 19 of this law, it shall be ordered to amend itself and be served a
warning. If the circumstances are serious, its Pharmaceutical Trading License
shall be revoked.
第八十六條 藥品標(biāo)識(shí)不符合本法第五十四條規(guī)定的，除依法應(yīng)當(dāng)按照假藥、劣藥論處的外，責(zé)令改正，給予警告；情節(jié)嚴(yán)重的，撤銷該藥品的批準(zhǔn)證明文件。
Article 86 A medicine whose mark is not in conformity with Article 54 of this
Law shall be handled as fake medicine or medicine of inferior quality. In
addition, a correction shall be made and a warning shall be served. If the
circumstances are serious, the approval certificate of this medicine shall be
revoked.
第八十七條
藥品檢驗(yàn)機(jī)構(gòu)出具虛假檢驗(yàn)報(bào)告，構(gòu)成犯罪的，依法追究刑事責(zé)任；不構(gòu)成犯罪的，責(zé)令改正，給予警告，對(duì)單位并處三萬元以上五萬元以下的罰款；對(duì)直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予降級(jí)、撤職、開除的處分，并處三萬元以下的罰款；
Article 87 A pharmaceutical inspection institution which produces false
inspection reports, where the circumstances are so serious as to constitute a
crime, shall be investigated for criminal liabilities; if a crime is not
constituted, it shall be ordered to amend and be served a warning. The
institution shall be concurrently imposed a fine of more than 30,000 but less
than 50,000 RMB, and the person-in-charge and other personnel directly liable
shall be demoted, dismissed from their posts, or expelled according to law, and
shall be concurrently be fined less than 30,000RMB.
有違法所得的，沒收違法所得；情節(jié)嚴(yán)重的，撤銷其檢驗(yàn)資格。藥品檢驗(yàn)機(jī)構(gòu)出具的檢驗(yàn)結(jié)果不實(shí)，造成損失的，應(yīng)當(dāng)承擔(dān)相應(yīng)的賠償責(zé)任。
If any unlawful income has been obtained, the unlawful income shall be
confiscated. If the circumstances are serious, the inspection qualification
certificate shall be revoked. If an inspection institution produces false
inspection reports and causes serious consequences, it shall bear corresponding
liabilities for compensation.
第八十八條
本法第七十三條至第八十七條規(guī)定的行政處罰，由縣級(jí)以上藥品監(jiān)督管理部門按照國(guó)務(wù)院藥品監(jiān)督管理部門規(guī)定的職責(zé)分工決定；吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證、《醫(yī)療機(jī)構(gòu)制劑許可證》、醫(yī)療機(jī)構(gòu)執(zhí)業(yè)許可證書或者撤銷藥品批準(zhǔn)證明文件的，由原發(fā)證、批準(zhǔn)的部門決定。
Article 88 The decision to impose administrative sanctions stipulated from
Article 73 to Article 87 by this Law shall be made by the pharmaceutical
supervisory and administrative departments at or above the county level in
conformity with the division of functions prescribed by the pharmaceutical
supervisory and administrative department under the State Council. The original
issue and approval departments shall decide regarding the revocation of the
Pharmaceutical Production License, the Pharmaceutical Trading License, the
Dispensing Permit of Medical Organizations, the practicing permit of medical
organizations, and the pharmaceutical approval certificates.
第八十九條 違反本法第五十五條、第五十六條、第五十七條關(guān)于藥品價(jià)格管理的規(guī)定的，依照《中華人民共和國(guó)價(jià)格法》的規(guī)定處罰。
Article 89 Violations of Article 55, 56, 57 of this Law concerning the price
control of pharmaceuticals shall be punished according to the Price Law of the
People's Republic of China.
第九十條
藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu)在藥品購(gòu)銷中暗中給予、收受回扣或者其他利益的，藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)或者其代理人給予使用其藥品的醫(yī)療機(jī)構(gòu)的負(fù)責(zé)人、藥品采購(gòu)人員、醫(yī)師等有關(guān)人員以財(cái)物或者其他利益的，由工商行政管理部門處一萬元以上二十萬元以下的罰款，有違法所得的，予以沒收；
Article 90 If pharmaceutical producing enterprises, trading enterprises and
medical organizations give or receive commissions or other interests in secret
during the purchase or sale of pharmaceuticals; and if pharmaceutical producing
enterprises, trading enterprises or their agents give any property or other
interests to the directors, buyers, physicians and other relevant persons in the
medical organizations where their medicines are used, a fine of more than 10,000
but less than 200,000 RMB shall be imposed and the unlawful income shall be
confiscated by the government body of industry and commerce administration
情節(jié)嚴(yán)重的，由工商行政管理部門吊銷藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)的營(yíng)業(yè)執(zhí)照，并通知藥品監(jiān)督管理部門，由藥品監(jiān)督管理部門吊銷其《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》；構(gòu)成犯罪的，依法追究刑事責(zé)任。
who, if the circumstances are serious, shall revoke the business licenses of
the pharmaceutical producing enterprises and pharmaceutical trading enterprises,
and shall notify the pharmaceutical supervisory and administrative departments
which shall revoke the Pharmaceutical Production License and Pharmaceutical
Trading License. If a crime is constituted, an investigation shall be made for
criminal liabilities.
第九十一條
藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)的負(fù)責(zé)人、采購(gòu)人員等有關(guān)人員在藥品購(gòu)銷中收受其他生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)或者其代理人給予的財(cái)物或者其他利益的，依法給予處分，沒收違法所得；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 91 If directors or buyers of pharmaceutical producing enterprises or
trading enterprises receive any property or other interests from other producing
enterprises, trading enterprises or their agents during the purchase or sale of
medicines, they shall be punished according to relevant regulations and shall
have their unlawful income confiscated. If a crime is constituted, an
investigation shall be made for criminal liabilities.
醫(yī)療機(jī)構(gòu)的負(fù)責(zé)人、藥品采購(gòu)人員、醫(yī)師等有關(guān)人員收受藥品生產(chǎn)企業(yè)、藥品經(jīng)營(yíng)企業(yè)或者其代理人給予的財(cái)物或者其他利益的，由衛(wèi)生行政部門或者本單位給予處分，沒收違法所得；對(duì)違法行為情節(jié)嚴(yán)重的執(zhí)業(yè)醫(yī)師，由衛(wèi)生行政部門吊銷其執(zhí)業(yè)證書；構(gòu)成犯罪的，依法追究刑事責(zé)任。
If the directors, buyers, physicians or other relevant persons in medical
organizations receive any property or other interests from pharmaceutical
producing enterprises, pharmaceutical trading enterprises or their agents, they
shall be punished by the administrative departments of health or the work units
where they work, and have their unlawful income confiscated. If practicing
physicians seriously violate the law, his practice certificate shall be revoked
by the administrative departments of health. If a crime is constituted, an
investigation shall be made for criminal liabilities in conformity with relevant
laws and regulations.
第九十二條
違反本法有關(guān)藥品廣告的管理規(guī)定的，依照《中華人民共和國(guó)廣告法》的規(guī)定處罰，并由發(fā)給廣告批準(zhǔn)文號(hào)的藥品監(jiān)督管理部門撤銷廣告批準(zhǔn)文號(hào)，一年內(nèi)不受理該品種的廣告審批申請(qǐng)；構(gòu)成犯罪的，依法追究刑事責(zé)任。
Article 92 Those who act against the administrative regulations concerning
pharmaceutical advertisement as provided in this Law shall be sanctioned in
conformity with the Advertisement Law of the PRC, have its advertisement
registration number revoked by the pharmaceutical supervisory and administrative
departments from which the registration number has been issued, and its
application for the approval of the advertisement regarding this variety of
medicines shall not be accepted for one year. If a crime is constituted, an
investigation of criminal liabilities shall be made in conformity with relevant
laws and regulations.
藥品監(jiān)督管理部門對(duì)藥品廣告不依法履行審查職責(zé)，批準(zhǔn)發(fā)布的廣告有虛假或者其他違反法律、行政法規(guī)的內(nèi)容的，對(duì)直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予行政處分；構(gòu)成犯罪的，依法追究刑事責(zé)任。
If a pharmaceutical supervisory or administrative department does not perform
its duty of inspection on pharmaceutical advertisements which results in the
publishing of advertisements containing falsehoods or other content against laws
and administrative regulations, the directly liable person in charge and other
responsible personnel shall be subject to administrative sanction. If their acts
constitute a crime, they shall be investigated for criminal liabilities in
conformity with relevant regulations.
第九十三條 藥品的生產(chǎn)企業(yè)、經(jīng)營(yíng)企業(yè)、醫(yī)療機(jī)構(gòu)違反本法規(guī)定，給藥品使用者造成損害的，依法承擔(dān)賠償責(zé)任。
Article 93 If pharmaceutical producing enterprises, trading enterprises or
medical organizations act against this law which results in damages to the users
of pharmaceuticals, they shall bear liabilities of compensation in conformity
with relevant regulations.
第九十四條
藥品監(jiān)督管理部門違反本法規(guī)定，有下列行為之一的，由其上級(jí)主管機(jī)關(guān)或者監(jiān)察機(jī)關(guān)責(zé)令收回違法發(fā)給的證書、撤銷藥品批準(zhǔn)證明文件，對(duì)直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予行政處分；構(gòu)成犯罪的，依法追究刑事責(zé)任：
Article 94 If a pharmaceutical supervisory and administrative department
violates this law with one of the following acts, a competent authority of a
higher level or a supervisory organization shall order it to withdraw the
unlawfully issued certificates, revoke the pharmaceutical approval certificates,
and render administrative sanctions against the directly liable person in charge
and other responsible personnel. If their acts constitute a crime, they shall be
investigated for criminal liabilities.
?。ㄒ唬?duì)不符合《藥品生產(chǎn)質(zhì)量管理規(guī)范》、《藥品經(jīng)營(yíng)質(zhì)量管理規(guī)范》的企業(yè)發(fā)給符合有關(guān)規(guī)范的認(rèn)證證書的，或者對(duì)取得認(rèn)證證書的企業(yè)未按照規(guī)定履行跟蹤檢查的職責(zé)，對(duì)不符合認(rèn)證條件的企業(yè)未依法責(zé)令其改正或者撤銷其認(rèn)證證書的；
(1) issue a certificate of qualification to an enterprise which does not meet
the requirements of the "Quality Control Standard of Pharmaceutical Production"
and the "Quality Control Standard of Pharmaceutical Trading," fail to conduct
inspections according to relevant regulations on the enterprises which have
already obtained certificates, or fail to order the unqualified enterprises to
amend themselves or revoke their certificates according to relevant regulations;
or
（二）對(duì)不符合法定條件的單位發(fā)給《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》或者《醫(yī)療機(jī)構(gòu)制劑許可證》的；
(2) issue a Pharmaceutical Production License, a Pharmaceutical Trading
License or a Dispensing Permit of Medical Organizations to a unit which does not
meet legal requirements;
?。ㄈ?duì)不符合進(jìn)口條件的藥品發(fā)給進(jìn)口藥品注冊(cè)證書的；
(3) issue a registration certificate of import to a medicine which does not
meet the requirements for import; or
（四）對(duì)不具備臨床試驗(yàn)條件或者生產(chǎn)條件而批準(zhǔn)進(jìn)行臨床試驗(yàn)、發(fā)給新藥證書、發(fā)給藥品批準(zhǔn)文號(hào)的。
(4) approve a clinic test when the requirements for clinic tests are not met,
or issue certificates of new medicines and pharmaceutical approval document
numbers when requirements for production are not met.
第九十五條
藥品監(jiān)督管理部門或者其設(shè)置的藥品檢驗(yàn)機(jī)構(gòu)或者其確定的專業(yè)從事藥品檢驗(yàn)的機(jī)構(gòu)參與藥品生產(chǎn)經(jīng)營(yíng)活動(dòng)的，由其上級(jí)機(jī)關(guān)或者監(jiān)察機(jī)關(guān)責(zé)令改正，有違法收入的予以沒收；情節(jié)嚴(yán)重的，對(duì)直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予行政處分。
Article 95 If a pharmaceutical supervisory and administrative department, or
an inspection institution it has established, or an organization exclusively
engaged in pharmaceutical inspection it has appointed, participates in the
production and trade of pharmaceuticals, the responsible authority of a higher
level or a supervisory organization shall order it to amend itself and have its
unlawful income confiscated. If the circumstances are serious, the directly
liable person in charge and other responsible personnel shall be subject to
administrative sanctions.
藥品監(jiān)督管理部門或者其設(shè)置的藥品檢驗(yàn)機(jī)構(gòu)或者其確定的專業(yè)從事藥品檢驗(yàn)的機(jī)構(gòu)的工作人員參與藥品生產(chǎn)經(jīng)營(yíng)活動(dòng)的，依法給予行政處分。
If a staff member in a pharmaceutical supervisory and administrative
department, or in an inspection institution it has established, or in an
organization exclusively engaged in pharmaceutical inspection it has appointed,
participates in the production and trade of pharmaceuticals, he or she shall be
subject to administrative sanction.
第九十六條
藥品監(jiān)督管理部門或者其設(shè)置、確定的藥品檢驗(yàn)機(jī)構(gòu)在藥品監(jiān)督檢驗(yàn)中違法收取檢驗(yàn)費(fèi)用的，由政府有關(guān)部門責(zé)令退還，對(duì)直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予行政處分。對(duì)違法收取檢驗(yàn)費(fèi)用情節(jié)嚴(yán)重的藥品檢驗(yàn)機(jī)構(gòu)，撤銷其檢驗(yàn)資格。
Article 96 If a pharmaceutical supervisory and administrative department or a
pharmaceutical inspection institution it has established or appointed unlawfully
collects inspection fees during a pharmaceutical supervision and inspection, it
shall be ordered by the government bodies concerned to make reimbursements, and
the directly liable person and other responsible personnel shall be subject to
administrative sanctions. If the circumstances are serious, the certificate of
qualification of the inspection institution which has unlawfully collected
inspection fees shall be revoked.
第九十七條 藥品監(jiān)督管理部門應(yīng)當(dāng)依法履行監(jiān)督檢查職責(zé)，監(jiān)督已取得《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》的企業(yè)依照本法規(guī)定從事藥品生產(chǎn)、經(jīng)營(yíng)活動(dòng)。
Article 97 A pharmaceutical supervisory and administrative department shall
perform its duty of supervision and inspection according to laws and
regulations, and shall supervise the production and trade of the enterprises
which have obtained a Pharmaceutical Production License or a Pharmaceutical
Trade License according to the regulations of this Law.
已取得《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》的企業(yè)生產(chǎn)、銷售假藥、劣藥的，除依法追究該企業(yè)的法律責(zé)任外，對(duì)有失職、瀆職行為的藥品監(jiān)督管理部門直接負(fù)責(zé)的主管人員和其他直接責(zé)任人員依法給予行政處分；構(gòu)成犯罪的，依法追究刑事責(zé)任。
If an enterprise which has obtained a Pharmaceutical Production License or a
Pharmaceutical Trade License produces and sells fake medicines and medicines of
inferior quality, the enterprise shall be investigated for legal liabilities
according to laws and regulations. In addition, the directly liable person in
charge and other responsible personnel in the pharmaceutical supervisory and
administrative department who have neglected or have been derelict in their duty
shall be subject to administrative sanction. If a crime is constituted, the
party shall be investigated for criminal liabilities according to laws and
regulations.
第九十八條 藥品監(jiān)督管理部門對(duì)下級(jí)藥品監(jiān)督管理部門違反本法的行政行為，責(zé)令限期改正；逾期不改正的，有權(quán)予以改變或者撤銷。
Article 98 A pharmaceutical supervisory and administrative department shall,
within a prescribed time limit, order a pharmaceutical supervisory and
administrative department of a lower level to correct an administrative act
which is not in conformity with this Law. If the administrative act is not
corrected within the prescribed time limit, the department shall have the power
to change or repeal it.
第九十九條 藥品監(jiān)督管理人員濫用職權(quán)、徇私舞弊、玩忽職守，構(gòu)成犯罪的，依法追究刑事責(zé)任；尚不構(gòu)成犯罪的，依法給予行政處分。
Article 99 If the personnel of the pharmaceutical supervision and
administration misuse their authority, engage in irregular practices due to
favoritism, or neglect their duties to such an extent that a crime is
constituted, they shall be investigated for criminal liabilities. If their acts
have not constituted a crime, they shall be subject to administrative sanctions.
第一百條 依照本法被吊銷《藥品生產(chǎn)許可證》、《藥品經(jīng)營(yíng)許可證》的，由藥品監(jiān)督管理部門通知工商行政管理部門辦理變更或者注銷登記。
Article 100 If a Pharmaceutical Production License or a Pharmaceutical Trade
License is revoked according to this Law, the pharmaceutical supervisory and
administrative department shall notify the industry and commerce administrative
department to alter or annul the registration.
第一百零一條 本章規(guī)定的貨值金額以違法生產(chǎn)、銷售藥品的標(biāo)價(jià)計(jì)算；沒有標(biāo)價(jià)的，按照同類藥品的市場(chǎng)價(jià)格計(jì)算。
Article 101 The value of goods as prescribed in this chapter is designated
according to the marked price of the unlawfully made or sold medicines. In the
absence of a marked price, the value of goods shall be designated according to
the market price of pharmaceuticals of the same kind.
第十章 附則
Chapter X Supplementary Provisions
第一百零二條 本法下列用語的含義是：
Article 102 For the purpose of this Law, the following definitions are
offered:
藥品，是指用于預(yù)防、治療、診斷人的疾病，有目的地調(diào)節(jié)人的生理機(jī)能并規(guī)定有適應(yīng)癥或者功能主治、用法和用量的物質(zhì)，包括中藥材、中藥飲片、中成藥、化學(xué)原料藥及其制劑、抗生素、生化藥品、放射性藥品、血清、疫苗、血液制品和診斷藥品等。
" Pharmaceuticals " means the articles intended for use in the prevention,
treatment or diagnosis of human diseases, or intended to effect the purposive
regulation of human physiological functions, for which indications or major
functions, usage and dosage are prescribed. They include raw traditional Chinese
medicinal materials, traditional medicines prepared in ready-to-use forms, and
other prepared Chinese medicines, medicinal chemicals and their preparations,
antibiotics, biochemical medicines, radioactive drugs, serums, vaccines, blood
products, diagnostic aids, etc.
輔料，是指生產(chǎn)藥品和調(diào)配處方時(shí)所用的賦形劑和附加劑。
" Supplementary materials " means the excipients and additives used for the
production and dispensing of pharmaceuticals.
藥品生產(chǎn)企業(yè)，是指生產(chǎn)藥品的專營(yíng)企業(yè)或者兼營(yíng)企業(yè)。
" Pharmaceutical producing enterprise " means an enterprise exclusively or
partly engaged in the production of pharmaceuticals.
藥品經(jīng)營(yíng)企業(yè)，是指經(jīng)營(yíng)藥品的專營(yíng)企業(yè)或者兼營(yíng)企業(yè)。
" Pharmaceutical trading enterprise " means an enterprise exclusively or
partly engaged in the trade of pharmaceuticals.
第一百零三條 中藥材的種植、采集和飼養(yǎng)的管理辦法，由國(guó)務(wù)院另行制定。
Article 103 Measures for the control of cultivation, collection and breeding
of all categories of medicinal materials used in traditional Chinese medicine
shall be seperately formulated by the State Council .
第一百零四條 國(guó)家對(duì)預(yù)防性生物制品的流通實(shí)行特殊管理。具體辦法由國(guó)務(wù)院制定。
Article 104 The State Council shall formulate detailed measures to carry out
special control on the circulation of preventive bioproducts.
第一百零五條 中國(guó)人民解放軍執(zhí)行本法的具體辦法，由國(guó)務(wù)院、中央軍事委員會(huì)依據(jù)本法制定。
Article 105 Detailed measures for the implementation of this law by the
Chinese People's Army shall be formulated by the State Council and the Central
Military Committee of the State on the basis of this Law.
第一百零六條 本法自２００１年１２月１日起施行。
Article 106 This Law shall enter into force as of December 1, 2001.
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