Catalogue of Precursor Chemicals (Category I Pharmaceutical Precursor Chemicals）

According to Article 2 of the Regulations on the Administration of Precursor Chemicals, precursor chemicals are classified into three categories. Category I comprises primary raw materials that can be used for drug manufacture, while Categories II and III include chemical agents that can be used for drug manufacture. The State implements a classification management and licensing system for the production, operation, purchase, transportation, import, and export of precursor chemicals.
For Category I Precursor Chemicals, they can be further subdivided into non-pharmaceutical and pharmaceutical types. This catalogue includes 4 Category I Precursor Chemicals (pharmaceutical) listed in the 2019 Classification and Variety Catalog of Precursor Chemicals, along with 18 additional Category I Precursor Chemicals (pharmaceutical) successively supplemented through joint announcements issued by six departments under the State Council.

Chemicals listed in the Catalogue of Precursor Chemicals (Category I Pharmaceutical Precursor Chemicals) shall comply with corresponding obligations for production, operation, purchase, transportation, and import/export:
- Applications for producing Category I precursor chemicals (pharmaceutical) must meet the conditions specified in Article 7 of the Regulations on the Administration of Precursor Chemicals. Production may only commence after obtaining a production license approved by the medical products administration department of the provincial, autonomous regional, or municipal people's government.
- Applicants for the production of Category I Precursor Chemicals (pharmaceutical) must meet the conditions specified in Article 9 of the Regulations on the Administration of Precursor Chemicals. They must obtain an operating permit after approval by the medical products administration department of the provincial, autonomous regional, or municipal people's government before commencing operations.
- To purchase Category I Precursor Chemicals (pharmaceutical), applicants must submit the documents specified in Article 10 of the Regulations on the Administration of Precursor Chemicals. Approval must be obtained from the medical products administration department of the provincial, autonomous regional, or municipal people's government, and a purchase permit must be obtained before purchase can proceed.
- Transportation of Category I Precursor Chemicals (pharmaceutical) requires approval from the public security organ of the municipal people's government at the prefecture level in the place of origin. Transportation may only proceed after obtaining a Precursor Chemical Transportation Permit through such approval.
- Applications for importing or exporting Category I Precursor Chemicals (pharmaceutical) must be submitted to the Ministry of Commerce for an Import or Export License."

Some mixtures that contain precursor chemicals are subject to precursor chemicals management. More information is needed for further determination. Welcome to contact REACH24H for more details.