Regulation on the Administration of Precursor Chemicals (2018 Revision)

Regulation on the Administration of Precursor Chemicals (2018 Revision) Regulation on the Administration of Precursor Chemicals (Issued by the Order No. 445 of the State Council on August 26, 2005; amended for the first time in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on July 29, 2014; and amended for the second time in accordance with the Decision of the State Council on Amending Certain Administrative Regulations on February 6, 2016; and amended for the third time according to the Order No. 703 of the State Council, Decision of the State Council to Amend Certain Administrative Regulations on September 18, 2018) Chapter I General Provisions Article 1 The present Regulation is formulated for the purpose of intensifying the administration of precursor chemicals, regulating the production, operation, purchase, transportation and import and export of precursor chemicals, preventing the use of precursor chemicals to manufacture drugs and maintaining the economic and social order. Article 2 The state adopts the classified administration and a licensing system for the production, operation, purchase, transportation and import and export of precursor chemicals. The precursor chemicals are classified into three categories. Category I refers to the major materials that may be used to produce drugs. Categories II and III refer to the chemical auxiliary substances that may be used to produce drugs. The specific classification and varieties of precursor chemicals are shown in the attachment of the present Regulation. Where the classification or variety of precursor chemicals requires any adjustment, the department of public security of the State Council shall, in collaboration with the drug supervision and administration department, the supervisory and administrative department of work safety, the administrative department of commerce, the administrative department of health and the General Administration of Customs of the State Council, report it to the State Council for approval. Where the people's government of the province, autonomous region or municipality directly under the Central Government believes it necessary to adjust the classification of precursor chemicals or to add any other variety beyond those as prescribed in the present Regulation within its administrative division, it shall set forth a suggestion to the department of public security of the State Council. The department of public security of the State Council shall, in collaboration with the relevant administrative departments of the State Council, raise a proposal and report it to the State Council for approval. Article 3 The department of public security, the drug supervision and administration department, the supervisory and administrative department of work safety, the administrative department of commerce, the administrative department of health, the General Administration of Customs, the administrative department of price, the administrative department of railways, the administrative department of communications, the market regulatory department and the competent department of ecology and environment of the State Council shall, according to their respective functions and duties, take charge of the relevant administration of precursor chemicals throughout the country. The relevant administrative departments of all the people's governments at the county level or above shall, according to their respective functions and duties, take charge of the relevant administration of the precursor chemicals within their administrative divisions. All the people's governments at the county level or above shall intensify the leadership in the administration of precursor chemicals, and coordinate and solve any problem arising from the administration of precursor chemicals in a timely manner. Article 4 The product name (including the scientific name and the generally used name), chemical molecular formula and ingredients shall be indicated in the packaging and instructions of products of precursor chemicals. Article 5 For the production, operation, purchase, transportation and import and export of precursor chemicals, not only the relevant provisions of the present Regulation shall be observed, but also, where it belongs to pharmaceuticals or dangerous chemicals, the relevant provisions of the laws and other administrative regulations on pharmaceuticals and dangerous chemicals shall be abided by. It's prohibited to smuggle or illegally produce, operate, purchase, transfer or transport any precursor chemicals. It's prohibited to trade in precursor chemicals by means of cash or in-kind, with the exception of any case whereby an individual legally purchases the pharmaceutical preparations of precursor chemicals under the item of pharmaceuticals in Category I or the precursor chemicals in Category III. An entity that engages in the production, operation, purchase and transportation and import and export of precursor chemicals shall establish an internal management system of precursor chemicals. Article 6 The state encourages the tip-off of any irregularity involving precursor chemicals to the relevant administrative departments such as the public security organ. The department that has received a tip-off shall keep confidential for the relevant tip-off maker. Where a tip-off has been verified, the people's government at the county level or above and the relevant administrative department shall grant an award to the relevant tip-off maker. Chapter II Management of Production and Operation Article 7 An entity, which applies for producing the precursor chemicals in Category I, shall meet the following requirements and shall obtain the production license upon the examination and approval of the administrative department as prescribed in Article 8 of the present Regulation before any production: (1)Having been legally registered as a production enterprise of chemical products or pharmaceuticals; (2)Having the production equipment, warehousing facilities and waste disposal facilities that comply with the state standards; (3)Having a strict management system of work safety and the reserve plan for environmental emergencies; (4)The legal representative and the technical and management personnel of the enterprise having the relevant knowledge of work safety as well as of precursor chemicals and having no criminal record; and (5)Satisfying any other requirement as prescribed by any law, regulation or rule. An entity that applies for producing the precursor chemicals under the item of pharmaceuticals in Category I shall not only meet the aforesaid requirements but also establish television supervision and control facilities and the alarming facilities that are connected to the network of the public security organ in such key areas as warehousing places. Article 8 An application for producing the precursor chemicals under the item of pharmaceuticals in Category I shall be subject to the examination and approval of the drug supervision and administration department of the people's government of a province, autonomous region, or municipality directly under the Central Government. An application for producing the precursor chemicals under any item other than pharmaceuticals in Category I shall be subject to the examination and approval of the supervisory and administrative department of food and drugs of the people's government of the province, autonomous region or municipality directly under the Central Government. The administrative departments as prescribed in the preceding paragraph shall, within 60 days as of receiving an application, carry out an examination on the application materials as submitted by the applicant. For any application that meets the relevant provisions, it shall issue a production license or make an indication on the relevant production license that has been obtained by the relevant enterprise. In the case of disapproval, a written explanation shall be given. The administrative departments may, when carrying out an examination on the application materials for the production license of precursor chemicals in Category I, organize an on-the-spot inspection and expert appraisal when necessary. Article 9 An enterprise, which applies for operating the precursor chemicals in Category I, shall meet the following requirements and shall obtain the operation license upon the examination and approval of the administrative department as prescribed in Article 10 of the present Regulation before any operation: (1)Having legally been registered as an operation enterprise of chemical products or pharmaceuticals; (2)Having a business place that meets the provisions of the state, and when it requires to store or keep any precursor chemicals, having the warehousing facilities that meet the technical standards of the state as well; (3)Having an operational and management system of precursor chemicals as well as complete sales network; (4)The legal representative and the technical and management personnel of the enterprise having the relevant knowledge of precursor chemicals and having no criminal record of drugs; and (5)Satisfying any other requirement as prescribed by any law, regulation or rule. Article 10 An application for operating the precursor chemicals under the item of pharmaceuticals in Category I shall be subject to the examination and approval of the supervisory and administrative department of food and drugs of the State Council. An application for operating the precursor chemicals under any item other than pharmaceuticals in Category I shall be subject to the examination and approval of the drug supervision and administration department of the people's government of a province, autonomous region, or municipality directly under the Central Government. The administrative departments as prescribed in the preceding paragraph shall, within 30 days as of receiving an application, carry out an examination on the application materials as submitted by the applicant. For any application that meets the relevant provisions, it shall issue an operation license or make an indication on the relevant operation license that has been obtained by the relevant enterprise. In the case of disapproval, a written explanation shall be given. The administrative departments may, when carrying out an examination on the application materials for operation license of the precursor chemicals in Category I, organize an on-the-spot inspection when necessary. Article 11 A production enterprise that has obtained the production license of precursor chemicals in Category I or has gone through the archival formalities of the precursor chemicals in Category II or III according to the provisions of paragraph 1 of Article 13 of the present Regulation may undertake the sale of self-produced precursor chemicals. However, an enterprise that has a sales network of precursor chemicals in Category I outside its factory shall obtain the operation license according to the provisions of the present Regulation. The pharmaceutical single preparations of the precursor chemicals under the item of pharmaceuticals in Category I shall be distributed by the designated operation enterprise of narcotic drugs and shall not be retailed. Article 12 An enterprise that has obtained the production or operation license of the precursor chemicals in Category I shall go to the market regulatory department to handle the formalities for the alteration of its business scope upon the strength of its production or operation license. Without the registration of alteration, no enterprise may carry out any production or operation of the precursor chemicals in Category I. Where any production or operation license of the precursor chemicals in Category I is revoked according to law, the administrative department shall inform the market regulatory department within 5 days as of making the decision on revocation. The enterprise whose license has been revoked shall go to the market regulatory department to handle the formalities for altering its business scope or for enterprise termination registration in a timely manner. Article 13 An enterprise that produces the chemicals liable to producing chemicals in Category II or III shall, within 30 days as of production, report such information as variety and quantity to the supervisory and administrative department of work safety of the municipal people's government of the local districted city for archival filing. An enterprise that operates the chemicals liable to producing chemicals in Category II shall, within 30 days as of......