中华人民共和国药品管理法【被修订】
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发 文 号:中华人民共和国主席令第十八号
发布单位:中华人民共和国主席令第十八号
发布日期:1984-09-20
实施日期:1985-07-01
escribes.Medicinal preparations made by medical units may not be sold on themarket.Article 20Medical units must implement a system of quality inspection whenpurchasing pharmaceuticals.
【章名】Chapter V Pharmaceutical Administration
Article 21The state encourages research on and development of new medicines.When working on a new medicine, it is necessary to submit, as required,the methods of production, quality indices, pharmacological andtoxicological testing results, and other related materials and samples tothe administrative department of health under the State Council or to theadministrative department of health of the relevant province, autonomousregion, or municipality directly under the Central Government. Clinicaltests or clinical verifications can be carried out only after approval.A new medicine which has completed its clinical tests or clinicalverifications and been approved after appraisal shall be issued acertificate by the administrative department of health under the StateCouncil.Article 22A new medicine can be put into production only after the administrativedepartment of health under the State Council has approved it and issued aregistered document of approval. However, this does not apply to theproduction of traditional Chinese medicines prepared in ready-to-useforms.A medicine standardized by the state or by a province, an autonomousregion, or a municipality directly under the Central Government shall beput into production only after the administrative department of health ofthe relevant province, autonomous region, or municipality directly underthe Central Government has made an examination of the medicine, given itapproval and issued a registered document of approval, seeking beforehandthe opinions of the authorities at the same level in charge of theproduction and trading of medicines. However, this does not apply to theproduction of traditional Chinese medicines prepared in ready-to-useforms.Article 23Pharmaceuticals must meet the pharmaceutical standards of the state orthose of the relevant province, autonomous region, or municipalitydirectly under the Central Government.The Pharmacopoeia of the People's Republic of China and the pharmaceuticalstandards promulgated by the administrative department of health under theState Council shall be the state pharmaceutical standards.The Pharmacopoeia Committee of the administrative department of healthunder the State Council shall be responsible for organizing theformulation and revision of the state pharmaceutical standards.Article 24The administrative department of health under the State Council andadministrative departments of health of provinces, autonomous regions, andmunicipalities directly under the Central Government may establishpharmaceutical examination and evaluation committees to carry outexamination and evaluation of new medicines and to reevaluate medicinesalready put into production.
Article 25The administrative department of health under the State Council shallorganize investigations of medicines which have been approved forproduction. It shall revoke the registered documents of approval if itdiscovers that the medicines' curative effects are uncertain or poor, orthat they produce serious adverse reactions or for other reasons areharmful to people's health.Production and sale of medicines whose registered documents of approvalhave been revoked shall not be allowed to continue; those which havealready been produced shall be destroyed or disposed of under thesupervision of the local administrative department of health.Article 26Import of medicines whose curative effects are uncertain or poor, or whichproduce adverse reactions or have other harmful effects on people's healthshall be prohibited.Article 27For any medicine which is to be imported for the first time, the importermust submit the manuals, quality standards, methods of inspection andother related information and samples, as well as the exporting country's(region's) certification documents approving its production, to theadministrative department of health under the State Council, and importcontracts may be signed only with the prior approval of the saiddepartment.Article 28Imported medicines must be inspected by the pharmaceutical inspectioninstitutions authorized by the administrative department of public healthunder the State Council; those having passed the inspection shall beallowed to be imported. Medicines to be imported in small quantities forurgent clinical needs by medical units or for personal use shall behandled according to customs regulations.Article 29The administrative department of health under the State Council shall havethe power to restrict or prohibit the export of traditional Chinesemedicinal materials and prepared Chinese medicines which are in shortsupply in the domestic market.Article 30Import Licences or Export Licences issued by the administrative departmentof health under the State Council are required for the import or export ofnarcotics and psychotropic substances falling within the restricted scopeprescribed by the administrative department of health under the StateCouncil.
Article 31Newly discovered domestic medicinal plants or medicinal plants introducedfrom abroad may be sold only after they have been examined and approved bythe administrative department of health of the relevant province,autonomous region, or municipality directly under the Central Government.Article 32Measures for controlling medicinal materials traditionally used by localpeople in certain regions shall be formulated by the administrativedepartment of health under the State Council.Article 33The production and sale of fake medicines are prohibited. A fake medicinehas either of the following characteristics:(1) the names of its components are different from those prescribed for itby state pharmaceutical standards or pharmaceutical standards of therelevant province, autonomous region, or municipality directly under theCentral Government;(2) a non-medical substance is passed off as a medicine, or one medicineis passed off as another.A medicine shall be handled as fake medicine in any of the followingcases:(1) where the use of the medicine has been prohibited by theadministrative department of health under the State Council;(2) where the medicine has been produced without being assigned aregistration number;(3) where the medicine has deteriorated and cannot be used as such; or(4) where the medicine has been contaminated and cannot be used as such.Article 34The production and sale of medicines of inferior quality shall beprohibited. A medicine of inferior quality has any of the followingcharacteristics:(1) the components of the medicine do not conform in quantity to thatrequired by state pharmaceutical standards or pharmaceutical standards ofthe relevant province, autonomous region, or municipality directly underthe Central Government;(2) the medicine has passed its expiry date; or(3) the medicine fails to meet the prescribed standards in other respects.Article 35Personnel in pharmaceutical producing or trading enterprises and inmedical units who have direct contact with medicines must undergo anannual medical examination. Persons who have contracted contagiousdiseases or any other disease which may contaminate the medicines shallnot be allowed to engage in any work which has direct contact withpharmaceuticals.
【章名】Chapter VI Packaging and Repackaging of Pharmaceuticals
Article 36Packaging must meet the specific quality requirements of thepharmaceuticals and facilitate their storage, transportation and medicaluse. If a medicine has a period of validity, it must be clearly indicatedon the package.Traditional Chinese medicinal materials must be packaged beforetransportation. There must appear on the package the name of the medicine,place of production, date, name of the consignor, and an indication thatthe quality of the medicine is up to standard.Article 37Packages of pharmaceuticals must,