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Precursor Chemicals Compliance Services
China is very strict in managing the import and export of precursor chemicals and currently implements a licensing system. A classified management and licensing system shall be implemented for the production, operation, purchase, transportation, import and export of precursor chemicals. Import and export of precursor chemicals by any means requires a license.
What are precursor chemicals?
Precursor chemicals refer to the main raw materials and chemical ingredients listed in the schedule of the "Regulations on the Administration of Precursor Chemicals" that can be used for drug production. Precursor chemicals are divided into three categories. The first category is the main raw materials that can be used for drug production, and the second and third categories are chemical compounds that can be used for drug production. Please see the schedule listed later in this article.
Compliance requirements for import and export precursor chemicals manufacturers
To apply for the import or export of precursor chemicals, the following materials shall be submitted and obtained.License for Import or Export of Precursor Chemicals, may engage in import and export activities:
A photocopy of the record registration certificate of the (I) foreign trade operator (the joint annual inspection certificate of foreign-invested enterprises);
Copy of (II) business license;
(III) the license or record-keeping certificate for the production, operation and purchase of precursor chemicals;
A copy of the (IV) import or export contract (agreement);
Identification of the (V) manager.
To apply for an export license for precursor chemicals, the importer shall also submit a certificate of legal use of precursor chemicals issued by the competent government department of the importer or a guarantee document of legal use of the importer. Those who import, export or transit, transship or pass through precursor chemicals shall truthfully declare to the Customs and submit an import or export license. For the import of pharmaceutical precursor chemicals in the first category, the customs clearance form for imported drugs issued by the food and drug supervision and administration department shall also be submitted.
Where precursor chemicals enter and exit between the territory and bonded areas under special customs supervision, such as bonded areas and export processing zones, or between the above-mentioned special customs supervision areas and bonded places, there is no need to apply for an import or export license for precursor chemicals.
For the import of pharmaceutical precursor chemicals in the first category, the customs clearance form for imported drugs issued by the pharmaceutical supervisory and administrative department shall also be submitted.
Annual Report Requirements
Units that produce, operate, purchase, transport or import or export precursor chemicals shallBefore March 31 of each year, report to the administrative department in charge of licensing or filing and the public security organ on the production, operation, purchase, transportation or import and export of precursor chemicals of the unit in the previous year; Conditional production, operation, purchase, transportation or import and export units may establish a computer network with the relevant administrative departments to report the relevant business situation in a timely manner.
Compliance Requirements for Manufacturers of Precursor Chemicals
To apply for the operation of precursor chemicals in category I, the following conditions shall be met and the operation license shall be obtained before the operation can be carried out:
The (I) is a chemical product trading enterprise or a pharmaceutical trading enterprise registered in accordance with the law;
If the (II) has a business site that meets the provisions of the State and needs to store and keep precursor chemicals, it shall also have storage facilities that meet the technical standards of the State;
The (III) has a management system for the operation of precursor chemicals and a sound sales network;
The legal representative and sales and management personnel of the (IV) enterprise have the relevant knowledge of precursor chemicals and have no drug criminal record;
(V) other conditions stipulated by laws, regulations and rules.
Those who deal in the second category of precursor chemicals shall, within 30 days from the date of operation, report the variety, quantity, and main flow direction of the business to the production safety supervision and management department of the municipal people's government divided into districts where they are located; those who deal in the third category of precursor chemicals shall, within 30 days from the date of operation, report the variety, quantity, and main flow direction of the business, to the local people's government at the county level production safety supervision and management department for the record.The competent administrative department specified in the preceding two paragraphs shall issue a filing certificate on the day of receipt of the filing materials.
Compliance Requirements for Manufacturers Purchasing Precursor Chemicals
To apply for the purchase of category I precursor chemicals, the following documents shall be submitted and the purchase license shall be obtained:
The (I) operation enterprise shall submit the business license of the enterprise and the proof of legal use;
(II) other organizations to submit registration certificate (establishment approval document) and legal use need to prove.
The purchase of the second and third categories of precursor chemicals shallBefore purchasing, the varieties and quantities to be purchased shall be filed with the public security organ of the local people's government at the county level.. Individuals are not allowed to purchase the first and second categories of precursor chemicals.
Transportation activities
The responsible entity may not transport the precursor chemicals until it has obtained a transport license for the precursor chemicals after examination and approval. To apply for a license for the transportation of precursor chemicals, a purchase and sale contract for precursor chemicals shall be submitted. If the owner is an enterprise, it shall submit a business license; if the owner is another organization, it shall submit a registration certificate (establishment approval document); If the owner is an individual, his personal identity certificate shall be submitted. If the carrier accepts the consignment of the consignor, the carrier shall check the transport license or record certificate provided by the consignor, and check whether the goods transported are consistent with the types of precursor chemicals specified in the transport license or record certificate; if they do not, they shall not be carried. For the transportation of precursor chemicals, the transportation personnel shall carry the transportation license or record certificate throughout the transportation.
Compliance Requirements for Manufacturers of Precursor Chemicals
To apply for the production of precursor chemicals in category I, the following conditions shall be met and a production license shall be obtained before production can be carried out:
The (I) is a chemical product production enterprise or a pharmaceutical production enterprise registered according to law;
The (II) has production equipment, storage facilities and pollutant treatment facilities that meet national standards;
The (III) has strict safety production management system and emergency plan for environmental emergencies;
The legal representative and technical and managerial personnel of the (IV) enterprise shall have the relevant knowledge of safe production and precursor chemicals, and shall have no criminal record of drugs;
(V) other conditions stipulated by laws, regulations and rules.
To apply for the production of pharmaceutical precursor chemicals in the first category, television monitoring facilities and alarm devices networked with public security organs should also be set up in key areas such as storage sites.
New Anrun Consulting provides you
Registration and consulting services for precursor chemicals, explosive hazardous chemicals and highly toxic chemicals
Telephone: 15801695345
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