Regulation on the Administration of Precursor Chemicals

Abstract:“Regulation on the Administration of Precursor Chemicals” was released on August 26th, 2005 and came into force on November 1st, 2005. The latest edition started to implement in last February, after 2 revisions in 2014 and 2016. The purpose of the regulation is to improve precursor chemicals management and thus to prevent them from being used to produce drugs. Specifically, the regulation stipulated detailed obligations of responsible party during the process of manufacturing, operating, purchasing, transporting, importing and exporting of the substances. Meanwhile, administrative departments and specific requirements regarding approval, supervision, management and punishment of precursor chemicals were also defined in the regulation.



What is Precursor Chemicals? How to classify?

Precursor Chemicals refer to the chemicals that can be used to manufacture drugs, include drug precursors, raw materials, chemical additives and other related substances.

The precursor chemicals are classified into three categories. Category I include the major materials that can be used for producing drugs. Categories II and III include the chemical reagents that can be used for producing drugs. The detailed classification and types of precursor chemicals are shown in the annex below.



Obligations of responsible party at different stages of supply chain

-Manufacturing Activities

An entity that applies for production of precursor chemicals in Category I, shall satisfy the following conditions to obtain the Production License before manufacturing activities:

(1)Legally registered as a manufacturer of chemical products or pharmaceuticals;

(2)Shall have processing equipment, warehouse facilities and pollutant disposal facilities that conform to the national standards;

(3)Shall formulate strict management system for safety work and prepared plans for environmental emergencies;

(4)The legal representative, technician and administrative staff of the enterprise shall have relevant knowledge of safety work and precursor chemicals, and have no record of drug-related crimes.

(5)Other conditions as regulated by laws, regulations and rules.

Additionally, to produce pharmaceutical precursor chemicals in Category I, the entity shall install video monitors and alarm devices connected with public security departments in key areas such as storage warehouse.

An enterprise that produces precursor chemicals in Category II or III, shall report production type, production amount and other information to local work safety supervision and administration departments of municipal people's government within 30 days from the date of production.

-Operating Activities

An entity that applies for the operation of precursor chemicals in Category I, shall satisfy the following conditions to obtain the Operating License before operating activities:

(1)Legally registered as an operating enterprise of chemical products or pharmaceuticals;

(2)Shall have operating site that conforms to the national regulation. For precursor chemicals need to be stored or kept, the entity shall also have warehouse facilities that conform to the national technical standards;

(3)Shall have management operating system and sound sales network for the distribution of precursor chemicals;

(4)The legal representative, salesperson and administrative staff of the enterprise shall have relevant knowledge of precursor chemicals, and have no record of drug-related crimes.

(5)Other conditions as regulated by laws, regulations and rules.

An enterprise that operates precursor chemicals in Category II, shall report production type, production amount, major flow direction and other information to local work safety supervision and administration departments of municipal people's government within 30 days from the date of production; An enterprise that operates precursor chemicals in Category III, shall report production type, production amount, major flow direction and other information to local work safety supervision and administration departments of people's government at the county level within 30 days from the date of production

-Purchasing Activities

An entity that applies for purchasing precursor chemicals in Category I shall submit the following certificates to the administrative department to obtain Purchase License:

(1)Operating enterprise shall submit business license and the demand certification for legal uses;

(2)Other organizations shall submit the certificate of registration (approval document of establishment) and the demand certification for legal uses.

An entity that purchases precursor chemicals in Category II or III, shall report purchase type and amount to local public security departments of people's government at the county level.

Individuals are not allowed to purchase precursor chemicals in Category I or II.

-Transporting Activities

Responsible Parties need to obtain the Transportation License before transporting activities. To apply for the transportation of precursor chemicals, the contract on purchase and sale of precursor chemicals shall be submitted. If the owner is an enterprise, its business license shall be submitted. If the owner is other organization, the certificate of registration (approval document of establishment) shall be submitted. If the owner is an individual, personal identity certificate shall be submitted.

When accepting the consignment from an owner, a carrier shall examine the transportation license or record-keeping certifications provided by the owner, and verify whether or not the freight is consistent with the type and other information of precursor chemicals stated in the transportation license or the record-keeping certification. If not, the goods are not allowed to be transported.

In the transportation of precursor chemicals, the transportation personnel shall carry the transportation license or the record-keeping certification throughout the transportation period from the departure.

-Importing and Exporting Activities

An Entity who applies for importing or exporting of precursor chemicals shall submit the following materials to obtain the import or export license before related activities:

(1)The photocopy of registration certification of foreign trade operator (the certificate of conformity for annual joint examination to foreign-invested enterprises);

(2)The duplicate of business license;

(3)The licenses or record-keeping certification for production, operation, or purchase of precursor chemicals;

(4)The duplicate of the import or export contract (agreement);

(5)The identity certification of handling person.

An entity who applies for export license of precursor chemicals shall, in addition, submit the certification documents of legal use of precursor chemicals issued by the governmental administrative department of the importer’s country.

For the import, export, transition, transshipment or transportation of precursor chemicals, declaration shall be faithfully made to the customs and the import or export license shall be submitted.

For the import of pharmaceutical precursor chemicals in Category I, the customs clearance notice of imported pharmaceuticals issued by food and drugs supervisory and administrative department shall be submitted.



附表(Annex

分类品种(Classification Category)

第一类(Category I)

1.1-苯基-2-丙酮(1-Phenyl-2-Propanone)

2.3,4-亚甲基二氧苯基-2-丙酮(Piperonyl methyl ketone)

3.胡椒醛(Piperonal)

4.黄樟素(Safrole)

5.黄樟油(Sassafras Oil)

6.异黄樟素(Isosafrole)

7.N-乙酰邻氨基苯酸(N-Acetylanthranilic Acid)

8.邻氨基苯甲酸(Anthranilic Acid)

9.麦角酸*(Lysergic Acid)

10.麦角胺*(Ergotamine)

11.麦角新碱*(Ergometrine)

12.麻黄素、伪麻黄素、消旋麻黄素、去甲麻黄素、甲基麻黄素、麻黄浸膏、麻黄浸膏粉等麻黄素类物质*

(Ephedrine, Pseudoephedrine, DL-Ephedrine, Phenylpropanolamine, Methylephedrine, Ephedrine soaked cream, powder of Ephedrine soaked cream and other similar substances)

13.羟亚胺(Hydroxylimine)

第二类(Categories II)

1.苯乙酸(Phenylacetic Acid)

2.醋酸酐(Acetic Anhydride)

3.三氯甲烷(Chlorofrom)

4.乙醚(Ethyl Ether)

5.哌啶(Piperdine)

第三类(Categories III)

1.甲苯(Toluene)

2.丙酮(Acetone)

3.甲基乙基酮(Methyl Ethyl Ketone)

4.高锰酸钾(Potassium Permanganate)

5.硫酸(Sulphuric Acid)

6.盐酸(Hydrochoric Acid)


Source:

Regulation on the Administration of Precursor Chemicals [Revised]

http://en.pkulaw.cn/display.aspx?cgid=59923&lib=law