The State Food and Drug Administration issued the requirements for the application materials for the import and export permits for narcotic drugs and psychotropic drugs

On November 30, the State Food and Drug Administration issued an announcement stating that in order to further regulate the application for the issuance of import and export permits for narcotic drugs and psychotropic drugs, in accordance with the "Drug Administration Law of the People's Republic of China", "Regulations on the Administration of Narcotic Drugs and Psychotropic Drugs" and other laws For the regulations, the State Food and Drug Administration has formulated the "Requirements for Application Documents for Import and Export Permits for Narcotic Drugs and Psychotropic Drugs", which are hereby promulgated and will be implemented as of the date of promulgation
.
Requirement of application materials for import and export licenses of narcotic drugs and psychotropic drugs 1.
Catalogue of application materials (1) Catalogue of application materials for export of narcotic drugs and psychotropic drugs 1.
Application form for the export of narcotic (psychotic) drugs
.
2.
A copy of the purchase contract or order
.
3.
Copy of export contract or order
.
4.
The original import permit issued by the anesthesia (psychiatric) drug administration agency of the importing country or region
.
If the importing country or region does not implement license management for exported drugs, it must provide: (1) Copy of the legal qualification certificate of the importing unit, notarized text, and certified text
.
(2) The original, notarized and certified copy of the legally used guarantee letter issued by the importer
.
5.
If the exported drugs are approved for production by domestic drug manufacturers, a copy of the corresponding drug registration certificate or chemical raw material drug approval notice must be provided
.
If the export drug is a product that a domestic enterprise accepts entrusted processing by an overseas enterprise, a copy of the certificate of approval for entrusted processing issued by the State Food and Drug Administration must be provided
.
6.
A photocopy of the export enterprise’s "Business License" and the "Foreign Trade Operator Registration Form"; 7.
Self-Guarantee Statement on the Authenticity of the Application Materials
.
(2) Catalogue of declaration materials for import of anesthetic drugs and psychotropic drugs for clinical use 1.
Application form for import of anesthetic (psychotic) drugs
.
2.
Copy of purchase contract or order
.
3.
A copy of the drug registration certificate or the approval notice of chemical raw materials (the import of special clinical needs may not be provided)
.
4.
A copy of the "Business License" and "Foreign Trade Operator Registration Form" of the importing entity
.
5.
If the exporting unit is the sales agency of the drug, it must also provide the agency agreement and the legal qualification certification documents, notarized texts and certification texts of the exporting unit
.
6.
Self-guarantee statement for the authenticity of the declared information
.
(3) Catalogue of declaration materials for imported narcotic drugs and psychotropic drugs for teaching and scientific research 1.
Application form for import of narcotic (psychotic) drugs
.
2.
A copy of the purchase contract or order
.
3.
Approval documents of corresponding scientific research projects or approval documents of corresponding competent authorities
.
4.
The certification documents of the legal qualification of the domestic user, the basis for the calculation of the quantity of the drug used, and the letter of guarantee issued by the user for the legal use and management of the drug
.
5.
A certificate document issued by the provincial drug supervision and administration department where the user unit is located that agrees to purchase the drug
.
6.
If the exporting unit is the sales agency of the drug, it is also required to provide the certification documents, notarized texts and certification texts of the exporting unit's legal qualifications
.
7.
If you accept the import agent entrusted by the user, a copy of the entrusted agency agreement and a copy of the import agency’s "business license" and "foreign trade operator registration form" are also required
.
8.
Self-guarantee statement for the authenticity of the declared information
.
2.
Requirements for application materials (1) General requirements 1.
The declared items and contents are accurate, and the declaration materials are complete and clear.
Use A4 size paper to print or copy
.
2.
The application form shall be filled in specifications, and the documents shall be authentic and effective
.
3.
The photocopy of the application materials should be stamped with the official seal of the applicant unit
.
(2) Specific requirements 1.
The name of the import (export) unit and the address of the import (export) unit in the application form must be consistent with the unit name and registered address in the submitted qualification certificate
.
2.
The import and export ports in the application form should be specific to the city, and up to two ports can be filled in
.
3.
The purchase contract or order, export contract or order must be signed and stamped by the responsible persons of both parties, and indicate the name and position of the signatory
.
4.
If there is no "Registration Form for Foreign Trade Operators", the "Approval Certificate for Taiwan, Hong Kong, Macao and Overseas Chinese Investment Enterprises of the People's Republic of China" or the "Approval Certificate for Foreign Investment Enterprises of the People's Republic of China" can be provided.
If there are other regulations in the free trade zone, the The regulations of the trade zone provide corresponding supporting documents
.
5.
The application materials should be in English or Chinese.
For materials not in English or Chinese, translation and translation notarized documents must be provided
.