中华人民共和国药品管理法实施办法

中华人民共和国药品管理法实施办法
MEASURES FOR THE IMPLEMENTATION OF THE PHARMACEUTICAL ADMINISTRA-TION LAW OF THE PEOPLE'S REPUBLIC OF CHINA

（Approved by the State Council on January 7， 1989 and promulgated by the Ministry of Public Health by Decree No. 1 on February 27， 1989）
颁布日期：19890227 　实施日期：19890227 　颁布单位：国务院、 卫生部

　　Chapter I General Provisions

　　Article 1 These Measures are formulated in accordance with the Pharmaceutical Administration Law of the People's Republic of China （hereinafter referred to as Pharmaceutical Administration Law）。

　　Article 2 These Measures are applicable to any units or individuals who are related to the production， selling， using， testing and examination or scientific research of medicines. These Measures are also applicable to the pharmaceutical enterprises in the People's Liberation Army that are engaged in the production of medicines for civilian use.

　　Article 3 In the production and selling of pharmaceuticals， social benefit shall be taken as the prime concern. The production， selling or use of fake or inferior medicines is strictly prohibited.

　　Without authorization no production or sales of pharmaceuticals or preparation of medicaments shall be allowed.

　　Chapter II Responsibility for the Supervision and Administration of Pharmaceuticals

　　Article 4 The administrative department of health under the State Council is in charge of the nationwide supervision over and administration of pharmaceuticals. Its principal responsibilities are as follows：

　　（1） to enforce the pharmaceutical Administration Law and these Measures；

　　（2） to draft laws and regulations related to the supervision and administration of pharmaceuticals， and to formulate provisions for the implementation of each law or regulations；

　　（3） to promulgate the Pharmacopoeia of China and the national standards for medicines；

　　（4） to examine and approve new medicines and to verify and issue approval certificates thereof；

　　（5） to exercise supervision over the production， trading and use of pharmaceuticals；

　　（6） to make investigation and appraisal of the curative effect and side effect of the medicines already put into production and to provide and publish information related to the quality；

　　（7） to make decisions on disciplinary sanctions in accordance with the pharmaceutical Administration Law and these Measures.

　　Pharmaceutical administration organs in the administrative departments of health at or above the county level are in charge of the supervision over and administration of pharmaceuticals within their respective jurisdiction.

　　Article 5 The medicine inspection organs set up by the administrative departments of health at or above the county level shall， under the latter's leadership， conduct medicine inspection in accordance with the standards for medicines set by the state and by the administrative department of health at the level of province， autonomous region or municipality directly under the Central Government.

　　Article 6 Medicine supervisor（s） shall be appointed in the administrative department of health at or above the county level. Medicine supervisors at the state level shall be entrusted by the administrative department of health under the State Council by credentials. Medicine supervisors at the provincial， autonomous region or municipal government （directly under the Central Government） level and at the autonomous prefecture， municipality or county level shall be nominated respectively by the administrative departments of health and entrusted with credentials by the people's governments at the corresponding levels. The duties of medicine supervisors at all levels shall be defined separately by the administrative department of health under the State Council.

　　Article 7 When carrying out their duties， the medicine supervisors ar

e required to present their credentials before they take sample testing and ask for relevant technical data， with a receipt in accordance with the state stipulations. They are required to keep confidential the technical data provided by the production enterprise and scientific research unit. The medicine supervisors may temporarily seal up some medicine pending further settlement. It is required of them to state the term of sealing up which shall not normally exceed 15 days.

　　Chapter III Procedure for the Verification and Approval of Licenses

　　Article 8 The procedures for examination and approval as stipulated in Paragraph 1 of Article 4 of the Pharmaceutical Administration Law denote that the establishment of a pharmaceutical producing enterprise （including all forms of inland associated enterprises， Chinese-foreign equity joint ventures and contractual joint ventures and foreign invested enterprises） shall involve， in addition to applying for approval for the capital construction of the enterprise in accordance with state stipulation， the following steps：

　　（1） the enterprise or its leadership organ submits an application to the competent department for the production and trading of pharmaceuticals of the province， autonomous region or municipality directly under the Central Government where the enterprise is located for examination and approval and then refer it to the administrative department of health at the same level.

　　（2） upon approval by the administrative department of health of the province， autonomous region or municipality directly under the Central Government， a Pharmaceutical Producer License shall be issued. The department in charge of the production and trading of pharmaceuticals and the administrative department of health are required to make a decision within 30 days of receipt of complete application materials.

　　Article 9 If a pharmaceutical production enterprise desires to set up a branch factory or any additional workshops outside the premise of the factory， it is required to submit an application to the department in charge of the production and trading of pharmaceuticals at the level of the province， autonomous region or municipality directly under the Central Government for examination and approval and then refer it to the administrative department of health at the same level for a Pharmaceutical Producers License， on which the status of the new set-up （a branch factory or a workshop） and its production scope must be clearly stated.

　　Article 10 The procedures for examination and approval stipulated in Paragraph 1 of Article 10 of the Pharmaceutical Administration Law denote that a pharmaceutical trading enterprise （including specialized and non- specialized whole-sale or retail drug stores or companies） should apply for a Pharmaceutical Trading Enterprise License in accordance with the following provisions：

　　（1） for a wholesale drug enterprise， an application must be submitted to the department in charge of the production and trading of pharmaceuticals at the level of the province， autonomous region or municipality directly under the Central Government for examination and approval and then be referred to the administrative department of health at the same government level for verification and approval before a Pharmaceutical Trading Enterprise License is issued；

　　（2） for a retail drug enterprise， an application must be submitted to the department in charge of the production and trading of pharmaceuticals at the autonomous prefecture， municipality or county government level for examination and approval and then be referred to the administrative department of health at the same government level for verification and approval before a Pharmaceutical Trading Enterprise License is issued. The department in charge of the production and trading of pharmaceuticals and the administrative department of health are required to make a decision w

ithin 30 days of receipt of complete application materials.

　　Article 11 The competent department for the production and trading of pharmaceuticals stated in Articles 4， 10 and 22 of the Pharmaceutical Administration Law refers to those pharmaceutical administration organs or departments appointed by the people's government at or above the county level.

　　Article 12 If a medical treatment unit needs to prepare some medicaments， it is required to submit an application to an administrative department of health at the level of the province， autonomous region or municipality directly under the Central Government for examination and approval before a Dispensing Permit is granted.

　　The administrative department of health is required to make a decision within 30 days of receipt of complete application materials.

　　Article 13 The term of validity for a Pharmaceutical Producer Licence， a Pharmaceutical Trading Enterprise Licence， or a Dispensing Permit is 5 years. If the licensee wishes to continue its production or trading or making medicament preparation upon expiration of the licence， it must reapply for permission. The entire application procedures must be repeated.

　　If an enterprise has gone bankrupt or has wound up business， the license it is holding should be cancelled by the administrative department of health that has issued it.

　　Article 14 Pharmaceutical Producer Licence， Pharmaceutical Trading Enterprise Licence， and Dispensing Permit shall be printed exclusively by the administrative department of health under the State Council.

　　Chapter IV Examination and Approval of New Medicines

　　Article 15 The state encourages research in and development of new medicines. All pharmaceutical research units， medical colleges， pharmaceutical production enterpris

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