In China, precursor chemicals refer to substances such as precursors, raw materials and chemical additives that can be used to manufacture drugs under the control of the state. The precursor chemicals are classified into three categories. Category I refers to the main raw materials that may be used to produce drugs. Categories II and III refer to the chemical additives that may be used to produce drugs.
China implements a classified management and licensing system for the production, operation, purchase, transportation, import and export of precursor chemicals, involving multi-level cooperation with different departments. Corresponding precursor chemicals may be referred to the Catalogue of Classifications and Categories of Precursor Chemicals, the Catalogue of Precursor Chemicals Subject to Import and Export Administration, and partial content of the Catalogue of Dual-Use Items and Technologies Subject to Import and Export License Administration.
The supplement of precursor chemicals shall be made based on the announcement of inclusion in the Catalogue of Classifications and Categories of Precursor Chemicals, which means chemicals listed in this Catalogue are precursor chemicals. Moreover, the Ministry of Public Security, with the cooperation of the Ministry of Commerce, the National Health Commission, the Ministry of Emergency Management, the General Administration of Customs, and the National Medical Products Administration, will publish the announcement on supplemented substances irregularly.
Obligations shall be met for non-pharmaceutical precursor chemicals in the supply chain:
► Enterprises shall apply for the Import and Export Licenses for Dual-use Items and Technologies to the Ministry of Commerce before the import and export of precursor chemicals.
► Enterprises intending to manufacture and operate Category I precursor chemicals shall apply for the permit of production and the permit of operation to the department of work safety supervision and administration at the provincial governments under their jurisdiction; enterprises intending to manufacture and operate Category II and III precursor chemicals shall apply for the record of production and operation to the department of work safety supervision and administration at the district level.
► Enterprises intending to purchase Category I precursor chemicals shall apply for the permit of purchase to the public security authorities at the provincial governments under their jurisdiction; enterprises intending to purchase Category II and III precursor chemicals shall apply for the record of purchase from the public security authorities of the people’s government at the county level.
► When transporting precursor chemicals across municipalities, enterprises involving in Category I precursor chemicals should apply for a transport license to the public security authorities on the people's government at the city level divided into districts at the place of shipment. Enterprises involving in Category II precursor chemicals should apply for a transport license to the public security authorities on the people's government at the county level at the place of shipment. Enterprises involving in Category III precursor chemicals should apply for the record to the public security authorities on the people's government at the county level at the place of shipment.
If your products have been included in the Catalogue of Precursor Chemicals, you should check whether these products are under other restrictions such as the Catalog of Hazardous Chemicals. If listed, corresponding obligations shall be met such as registration and permit application.
The identification of precursor mixtures in import and export
If any of the following conditions are met, mixtures can be identified as precursor chemicals and obligations are enumerated in the following:
1) Goods containing any of toluene, acetone, methyl ethyl ketone, sulphuric acid with a concentration above 40% (excluding 40%) and goods containing a concentration of hydrochloric acid above 10% (excluding 10%);
2) Goods containing other precursor chemicals listed in the Catalogue of Precursor Chemicals Subject to Import and Export Administration other than the above 5 substances. However, compound pharmaceutical preparations with precursor chemicals are excluded.
Regulations and standards
► Regulation on the Administration of Precursor Chemicals
► Provisions on the Management of Import and Export of Precursor Chemicals
► Measures for the Administration of Import and Export Licenses for Dual-use Items and Technologies
► Measures for the Administration of Supply, Marketing and Transportation of Precursor Chemicals
► Measures for the Licensing for Production and Operation of Non-pharmaceutical Precursor Chemicals
Regulatory authorities
► Ministry of Public Security of the People’s Republic of China
► Ministry of Emergency Management of the People’s Republic of China
► Competent departments in charge of commercial affairs
► Customs authorities
► Administrative departments for industry and commerce
How to obtain the list?
- Click here to search for the latest inventory
- Contact CIRS Group to purchase the latest version of the Catalogue
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