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The electronic certification of "Certificate of API Export to the EU" and "Certificate of Export Sales of Drugs" is enabled

 Last Update: 2022-11-04
 Source: Internet
 Author: User

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In order to thoroughly implement the major decisions and deployments of the Party Central Committee and the State Council on deepening the reform of "license separation", optimize the business environment, further stimulate the vitality of the development of market entities, improve the application service level of the "Internet + drug supervision" of the State Food and Drug Administration, and provide more efficient and convenient government services for pharmaceutical export enterprises, after research, it has been decided that from December 1, 2022, the electronic certificates of "Certificate of API Export to the EU" and "Certificate of Export Sales of Drugs" will be officially used, and the relevant matters are hereby announced as follows:

1.
Starting from December 1, 2022, electronic certification
will be used for the issuance of the Certificate of API Export to the EU and the Certificate of Export Sales of Drugs.
Electronic certificates have the same effect
as paper certificates.

2.
Combined with China's drug export work practices and WHO's latest guidelines, a new template for the "Certificate of Export Sales of Drugs" (see annex)
will be used.
Starting from December 1, 2022, all provincial drug regulatory departments shall issue the Certificate of Export and Sales of Drugs in accordance with the updated template
.

3.
Do a good job in publicizing and guiding the use of electronic certificates
.
If using the electronic certificate issued by the NMPA application system, the applicant must first register in the NMPA online office hall and authenticate his real name, enter the "My License" column of the legal person space of the online office hall, or log in to the "China Food and Drug Administration APP" to view and download the corresponding electronic certificate
.
Applicants should keep the electronic certificate
safe.
For frequently asked questions and answers to electronic certificates issued by the NMPA, see the electronic license help column of the online office hall of the NMPA
.

4.
Where electronic certificates issued by the provincial application system are used, the provincial-level drug regulatory departments shall clarify the relevant handling guidelines to enterprises within the administrative region and provide guidance and services
.

This is hereby announced
.

Attachment: Template of Certificate of Export Sales of Drugs (2022 Edition)

NMPA

October 27, 2022

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