Measures for the Licensing for Production and Operation of Non-pharmaceutical Precursor Chemicals

Measures for the Licensing for Production and Operation of Non-pharmaceutical Precursor Chemicals Order of the State Administration of Work Safety (No. 5) The “Measures for the Licensing for Production and Operation of Non-pharmaceutical Precursor Chemicals”, which were deliberated and adopted at the director general's working meeting of the State Administration of Work Safety on March 21, 2006, are hereby promulgated, and shall come into force on April 15, 2006. Director General Li Yizhong April 5, 2006 Measures for the Licensing for Production and Operation of Non-pharmaceutical Precursor Chemicals Chapter I General Provisions Article 1 The present Measures are formulated in accordance with the “ Regulation on the Administration of Precursor Chemicals ” (hereinafter referred to as the “ Regulation ”) as well as other relevant laws and administrative regulations for the purpose of strengthening the administration of non-pharmaceutical precursor chemicals, regulating the production and operation of non-pharmaceutical precursor chemicals, preventing non-pharmaceutical precursor chemicals from being used to manufacture drugs, and maintaining economic and social order. Article 2 The term non-pharmaceutical precursor chemicals as mentioned in the present Measures shall refer to the non-pharmaceutical major materials and chemical auxiliary substances which are determined in the Attached Table of the “ Regulation ” and may be used to produce drugs. For the classes and varieties of non-pharmaceutical precursor chemicals, please see the Attached Table of the present Measures, i.e. “Catalogue of Classes and Varieties of Non-pharmaceutical Precursor Chemicals”. When the adjustment of the Attached Table of the “Regulation”, i.e. “Catalogue of Classes and Varieties of Precursor Chemicals” or “Catalogue of Hazardous Chemicals” involves the Attached Table of the present Measures, the “Catalogue of Classes and Varieties of Non-pharmaceutical Precursor Chemicals” shall be adjusted accordingly and promulgated. Article 3 The state applies a license system to the production and operation of non-pharmaceutical precursor chemicals. The production and operation of non-pharmaceutical precursor chemicals of Class 1 shall be subject to license-based administration, while the production and operation of precursor chemicals of Class 2 and Class 3 shall be subject to archival certificate-based administration. The administrative department of work safety of the people's government of a province, autonomous region, or municipality directly under the Central Government shall take charge of examining and approving the production and operation of non-pharmaceutical precursor chemicals of Class 1 within its own jurisdiction as well as issuing the licenses therefor. The administrative department of work safety of a people's government at the districted city level shall take charge of issuing archival certificates for production and operation of non-pharmaceutical precursor chemicals of Class 2 or for production of non-pharmaceutical precursor chemicals of Class 3 within its own jurisdiction. The administrative department of work safety of the people's government at the county level shall take charge of issuing archival certificates for operation of non-pharmaceutical precursor chemicals of Class 3 within its own jurisdiction. Article 4 The State Administration of Work Safety shall supervise and guide the licensing for production and operation of non-pharmaceutical precursor chemicals all over China, and the archival administration thereof, as well. The administrative department of work safety of each people's government at the county level or above shall take charge of implementing the system of licensing for production and operation of non-pharmaceutical precursor chemicals within its own jurisdiction as well as the supervision and administration thereof. Chapter II Licensing for Production and Operation Article 5 Whoever intends to produce or operate a non-pharmaceutical precursor chemical of Class 1 must not engage in the production or operation activities until having obtained the license for production or operation of the non-pharmaceutical precursor chemical. Article 6 Whoever intends to produce or operate a non-pharmaceutical precursor chemical of Class 1 shall meet the conditions prescribed in Article 7 and Article 9 of the “ Regulation ”. Article 7 Where a producer applies for a license for production of a non-pharmaceutical precursor chemical, it shall submit the following documents and materials to the administrative department of work safety of the local people's government at the provincial level, and shall be responsible for the authenticity thereof: (1) a letter of application for the license for production of the non-pharmaceutical precursor chemical (in duplicates); (2) the materials on introduction of the production equipment, warehousing facilities and pollutant treatment facilities; (3) its precursor chemical management rules and the plan on responding to environmental emergencies; (4) the work safety management rules; (5) the materials proving that its legal representative or principal person-in-charge, as well as its technicians and managers have corresponding knowledge on work safety; (6) the materials proving that its legal representative or principal person-in-charge, as well as its technicians and managers have corresponding knowledge on precursor chemicals but have no records on drug-involved crimes; (7) a counterpart of its industrial and commercial business license (photocopy); and (8) the directions of the product package and the directions to use chemicals. For a producer of hazardous chemicals, it shall, in addition, submit its work safety license of hazardous chemical production enterprise, and the hazardous chemical registration certificate (photocopies), without having to submit the documents and materials as required by Items (4), (5) and (7) of the present article. Article 8 Where an operator applies for a license for operation of a non-pharmaceutical precursor chemical, it shall submit the following documents and materials to the administrative department of work safety of the local people's government at the provincial level, and shall be responsible for the authenticity thereof: (1) a letter of application for the license for operation of the non-pharmaceutical precursor chemical (in duplicates); (2) the materials on introduction of the production site and the warehousing facilities; (3) its precursor chemical management rules and the sales network documents containing the contents such as sales institutions, sales agencies and users, etc.; (4) the materials proving that its legal representative or principal person-in-charge, as well as its sales staff and managers have corresponding knowledge on precursor chemicals but have no records on drug-involved crimes; (5) a counterpart of its industrial and commercial business license (photocopy); and (6) the directions of the product package and the directions to use chemicals. For an operator of hazardous chemical, it shall, in addition, submit its license for operation of hazardous chemicals (photocopy), without having to submit the documents and materials as required by Item (5) of the present article. Article 9 The administrative department of work safety of the people's government of a province, autonomous region, or municipality directly under the Central Government shall, with respect to......