Notice of the General Department of the State Food and Drug Administration on the use of the drug import and export permit management system.


Release time:

2020-01-02

The drug administrations of all provinces, autonomous regions and municipalities directly under the Central Government, and the drug administration of Xinjiang Production and Construction Corps:

In order to implement the "Notice of the State Council on Printing and Distributing the Work Plan for Optimizing the Port Business Environment and Promoting Cross-border Trade Facilitation" (Guo Fa [2018] No. 37) and the State Council's requirements for online declaration and online processing of all export link supervision documents before the end of 2019, The State Drug Administration and the State Port Administration Office of the General Administration of Customs jointly established a drug import and export permit management system on the "single window" public platform. The relevant matters are hereby notified as follows:

The 1. Drug Import and Export Permit Management System was officially launched on December 25, 2019, and is used to handle the application, acceptance, approval and online verification of the import and export of protein assimilation agents and peptide hormones online. The applicant shall submit the electronic data of the import and export application of anabolic agents and peptide hormones through the system, and submit the relevant supporting documents of the competent government department of the importing country for verification in accordance with the Anti Doping regulations. The applicant can also handle import and export business such as import drug filing on the "single window" website.

The provincial drug regulatory departments of the 2. shall determine the approval level and corresponding staff in combination with the actual work of import and export approval of anabolic preparations and peptide hormones, communicate with the software development unit, and set it in the system to ensure that the system is put into operation on time. If it is necessary to apply for or add a key (USBkey), it shall be handled as soon as possible in accordance with the requirements of the Notice on Preparing for the Application of the New Drug Import and Export Permit Management System (Drug Administration and Drug Administration Letter [2019] No. 537).

The 3. drug import and export permit management system already has the function of sharing the information of anabolic agents and peptide hormone permits with the customs department, and there is no need to upload information to the customs system.

The operation manuals (Annex 1 and Annex 2) of the 4. application side and approval side can be downloaded from this system. If any problems are found during the use of the system, please contact the "single window" customer service hotline (010-95198 to labor) or communicate through WeChat work group (see Annex 3 for the two-dimensional code of WeChat work group).

The 5. construction and use of the drug import and export permit management system is a concrete measure to implement the reform of the State Council and optimize the business environment. The provincial drug regulatory departments should strengthen organization and leadership, urge and guide relevant enterprises and staff to familiarize themselves with the system functions as soon as possible, and carry out acceptance and approval work in strict accordance with the relevant regulations on the import and export management of protein assimilation preparations and peptide hormones, so as to effectively reduce the burden on enterprises.

Annex: 1. Operation Manual of Application End of "Single Window" Drug Import and Export Permit Management System

2. "Single Window" Drug Import and Export Permit Management System Approval End Operation Manual

3. Two-dimensional code of WeChat working group of drug import and export permit management system

 

General Division of the State Food and Drug Administration

23 December 2019