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In accordance with the requirements of the Measures for the Supervision and Administration of Online Sales of Drugs, in order to guide drug regulatory departments at all levels to orderly carry out the filing of third-party platforms for drug online transactions and the reporting of pharmaceutical online sales enterprises, the relevant matters are hereby announced as follows:
1.
Filing of third-party platforms for online drug transactions
(1) Handle filing
Third-party platforms for online drug transactions shall, in accordance with Article 18 of the Measures for the Supervision and Administration of Online Drug Sales, file with the provincial-level drug regulatory department where the platform is located, truthfully fill in the filing form for the third-party platform for online drug transactions (Annex 1), and submit relevant materials (Annex 2).
(2) Material verification
The provincial-level drug regulatory department shall check the materials submitted by the enterprise, and record them if they meet the requirements; Where the submitted materials are incomplete or do not conform to the legally prescribed circumstances, the matters
requiring supplementary materials shall be notified at one time.
All localities are encouraged to follow the overall requirements of the State Council's "decentralization, management and service" and combine local realities to use information technology to facilitate
enterprises' filing procedures.
The provincial-level drug regulatory department shall disclose the filing information to the public within 7 working days after filing (Annex 3).
The filing information disclosed shall include: enterprise name, legal representative, website name, network client application name, website domain name, website IP address, telecommunications business license and non-operational Internet information service filing number, drug online transaction third-party platform filing number, etc
.
The provincial-level drug regulatory departments shall, within 3 months after the filing of third-party platforms for online drug transactions, organize on-site inspections of third-party platforms for online drug transactions, and ensure that at least one inspection is carried out each year, guiding enterprises to carry out operations
in a lawful and orderly manner.
(3) Change filing
Where there is a change in the publicity and filing information of the third-party platform for drug online trading, the change shall be filed with the provincial drug regulatory department within 10 working days of the date of the change in relevant information; Where other ICP filing information changes, it shall be updated in a timely manner
.
Where the provincial-level drug regulatory department discovers during routine inspections that the filing information of the third-party platform for drug online transactions is inconsistent with the reality, it shall urge the enterprise to update the filing information
in a timely manner.
(4) Cancel filing
Where third-party platforms for online drug transactions no longer carry out relevant business, they shall continue to publicize relevant information in a conspicuous position on the homepage of the platform 20 working days in advance, and take the initiative to cancel the filing with the local provincial-level drug regulatory department
.
The materials for cancellation of filing shall be affixed with an official seal, and the content shall include the filing information to be canceled, a statement of commitment not to carry out third-party platform services for drug online transactions before obtaining filing, and so forth
.
Where the actual situation of the third-party platform for online drug trading is inconsistent with the filing information and cannot be contacted, if the provincial drug regulatory department still cannot be contacted or cannot carry out on-site inspections after 10 working days of public announcement, the filing shall be cancelled
.
Where the provincial-level drug regulatory department discovers that an enterprise has provided false materials for filing or that there are violations of laws and regulations in routine supervision, it shall handle it
in accordance with law.
Where the situation is serious, it shall be announced to the public, and promptly reported
to the competent departments for communications at the same level.
Where an enterprise that has completed the cancellation of filing intends to re-launch third-party platform services for drug online transactions, it shall re-file with the local provincial-level drug regulatory department
.
(5) Data push
Information on filing, change filing, and cancellation of filing needs to be simultaneously pushed to the national drug regulatory data sharing platform
.
2.
Report of pharmaceutical online sales enterprises
Enterprises engaged in online sales of drugs shall report to the drug regulatory department in accordance with Article 11 of the Measures for the Supervision and Administration of Online Drug Sales, and truthfully fill in and submit the report information form for online pharmaceutical sales enterprises with official seals (Annex 4).
。
Where enterprises engaged in online drug sales carry out business activities through multiple self-built websites, network client applications (including mini programs), etc.
, they shall list them one by one in the content of the report; Where the same or more third-party platforms for drug online trading carry out business activities, the name of the third-party platform, the name of the store, and the link to the home page of the store shall be listed
one by one in the content of the report.
The drug regulatory departments shall include the drug online sales activities of relevant enterprises in their daily supervision, and urge enterprises to continue to carry out business activities
in accordance with laws and regulations.
Drug regulatory departments at all levels may, in combination with the actual supervision within their administrative regions, refine specific content, improve relevant requirements, organize enterprises to perform filing and reporting obligations in accordance with laws and regulations, review and check the qualification and ability of enterprises in strict accordance with statutory requirements, and strengthen supervision during and after the event
.
Provincial-level drug regulatory departments shall also do a good job of aggregating and sorting out filing and reporting information, and promptly grasp the situation of
third-party drug online trading platforms and pharmaceutical online sales enterprises within their administrative regions.
This is hereby announced
.
Annexes: 1.
Filing form of third-party platform for drug online transactions 2.
List of filing materials for third-party platforms for drug online transactions Filing information on third-party platforms for drug online transactions 4.
Drug online sales enterprise report information form, State Food and Drug Administration
November 30, 2022
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