China Food and Drug Regulatory Information Network
 
contant us
Home Market Overview Conferences BBS
International Exchange & Forums
Introduction to E-newsletter
Profile of Industry
Laws & Regulations - Drugs - Regulations on Administration of Precursor Chemicals
Regulations on Administration of Precursor Chemicals
 
2012/3/20 14:46:37¡¡Source: ¡¡Hits:

Chapter I General Provisions

Article 1 These Regulations are formulated for the purposes of reinforcing the administration of precursor chemicals, regulating the manufacture, distribution, purchase, transport, import and export of precursor chemicals, preventing them from being used for making illicit drugs, and maintaining the economic and social order.

Article 2      The State applies a classified administration and licensing system to the manufacture, distribution, purchase, transport, import and export of precursor chemicals.

Precursor chemicals are classified into three categories. Precursor chemicals in Category I are the main materials that can be used for making illicit drugs, and precursor chemicals in Category II and Category III are chemical agents that can be used for making illicit drugs. The detailed classification and types of precursor chemicals are listed in the Table annexed to these Regulations.

Where there is a need to adjust the classification or types of precursor chemicals, the public security department of the State Council shall, jointly with the food and drug administration department, the work safety administration department, the competent commerce department, the competent health department of the State Council, and the General Administration of Customs, put forward a proposal therefor and report the same to the State Council for approval.

When deeming it necessary to adjust the classification or add types of the precursor chemicals other than the ones specified in these Regulations within its administrative area, the people¡¯s government of the province, autonomous region or municipality directly under the Central Government shall propose as such to the public security department of the State Council, which shall, jointly with the relevant competent administrative departments of the State Council, put forward a proposal therefor and report the same to the State Council for approval.

Article 3      The public security department, the food and drug administration department, the work safety administration department, the competent commerce department, the competent health department, the General Administration of Customs, the competent pricing department, the competent railway department, the competent communications department, the administrative department for industry and commerce and the competent environmental protection department of the State Council shall, in accordance with their respective functions and duties, be responsible for the relevant administration of  precursor chemicals throughout the country; and the relevant competent administrative departments of local people¡¯s governments at or above the county level shall, in accordance with their respective functions and duties, be responsible for the relevant administration of precursor chemicals within their respective administrative areas.

Local people¡¯s governments at or above the county level shall reinforce the leadership in the administration of precursor chemicals, and in a timely manner, coordinate the efforts in resolving the problems that arise from the administration of precursor chemicals.

Article 4      The names (including scientific names and common names), chemical molecular formulas and chemical composition of precursor chemicals shall be specified on their packaging and in their specifications.

Article 5      In addition to the provisions of these Regulations, the manufacture, distribution, purchase, transport, import and export of the precursor chemicals that are of pharmaceuticals or hazardous chemicals shall be in compliance with the provisions on pharmaceuticals or hazardous chemicals of laws and other administrative regulations.

Any smuggling or illicit manufacture, distribution, purchase, transfer or transport of precursor chemicals is prohibited.

Any transaction of precursor chemicals in cash or kind is prohibited. However, an individual may legally purchase preparations of pharmaceutical precursor chemicals in Category I, and the precursor chemicals in Category III.

Any unit that manufactures, distributes, purchases, transports, imports or exports precursor chemicals shall establish an internal system for management of precursor chemicals.

Article 6 The State encourages the report against illegal activities related to precursor chemicals to the relevant competent administrative departments such as the public security department. The department that receives the report shall keep the reporting person confidential; and the people¡¯s government at or above the county level and the relevant competent administrative departments shall award the reporting person if the report is proved to be true.

Chapter II Administration of Manufacture and Distribution

Article 7      Anyone applying for the manufacture of precursor chemicals in Category I shall meet the following requirements, and shall not commence manufacturing until it is approved by the competent administrative department specified in Article 8 of these Regulations and obtains a manufacture license:

(1)   being a chemical product manufacturer or pharmaceutical manufacturer that is legally registered;

(2)   having manufacture equipment, storage facilities and pollutant disposal facilities that are in conformity with the national standards;

(3)   having a strict work safety management system and a preparedness plan for environmental emergencies;

(4)   the legal representative and the technical and managerial personnel thereof have relevant knowledge on work safety and precursor chemicals, and have no record of drug-related crimes; and

(5)   other requirements provided for by laws, regulations and rules.

To apply for the manufacture of pharmaceutical precursor chemicals in Category I, the applicant shall, in addition, install video monitors within key areas such as storage places and alarm devices connected to the public security department.

Article 8      Anyone applying for the manufacture of pharmaceutical precursor chemicals in Category I shall be subject to approval by the food and drug administration department of the State Council; anyone applying for the manufacture of non-pharmaceutical precursor chemicals in Category I shall be subject to approval by the work safety administration department of the people¡¯s government of the province, autonomous region or municipality directly under the Central Government.

The competent administrative departments specified in the preceding paragraph shall examine the application materials submitted by the applicant within 60 days from the date of receipt of such materials, and, if the applicant meets the relevant requirements, issue a manufacture license to the applicant or mark the relevant manufacture license that the applicant has obtained for confirmation. If no license is granted, the applicant shall be notified in writing with the reasons therefor stated.

When necessary, on-site inspection or expert evaluation may be conducted in examining the application materials for the manufacture of precursor chemicals in Category I.

Article 9&n

[1] [2] [3] [4] [5] [6] Next

Laws & Regulations more
Medical Devices more
CHINA CENTER FOR PHARMACEUTICAL INTERNATIONAL EXCHANGE