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          May 31, 2010
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          Announcement of the National Medical Products Administration on Regulating the Recordation and Reporting of Online Sales of Medicinal Products [Effective]
          國家藥監局關于規范藥品網絡銷售備案和報告工作的公告 [現行有效]
          【法寶引證碼】
           
            
            
          Announcement of the National Medical Products Administration on Regulating the Recordation and Reporting of Online Sales of Medicinal Products 

          國家藥監局關于規范藥品網絡銷售備案和報告工作的公告

          (Announcement No. 112 [2022] of the National Medical Products Administration) (國家藥品監督管理局公告2022年第112號)

          In accordance with the requirements of the Measures for the Supervision and Administration of Online Sales of Medicinal Products, for the purpose of guiding the medical products administrations at all levels in conducting the work concerning the recordation of third-party platforms for online trading in medicinal products and the reporting by enterprises selling medicinal products online in an orderly manner, the relevant matters are hereby announced as follows: 根據《藥品網絡銷售監督管理辦法》的要求,為指導各級藥品監督管理部門有序開展藥品網絡交易第三方平臺備案和藥品網絡銷售企業報告工作,現將有關事項公告如下:
          I. Recordation of third-party platforms for online trading in medicinal products   一、藥品網絡交易第三方平臺備案
          (1) Handling of recordation (一)辦理備案
          A third-party platform for online trading in medicinal products shall, in accordance with Article 18 of the Measures for the Supervision and Administration of Online Sales of Medicinal Products, undergo the recordation formalities with the provincial medical products administration at the place where the platform is located, faithfully fill out the Recordation Form for a Third-Party Platform for Online Trading in Medicinal Products (Annex 1), and submit relevant materials (Annex 2). 藥品網絡交易第三方平臺應當按照《藥品網絡銷售監督管理辦法》第十八條規定向平臺所在地省級藥品監督管理部門備案,如實填寫藥品網絡交易第三方平臺備案表(附件1),并提交相關材料(附件2)。
          (2) Verification of materials (二)材料核對
          Provincial medical products administrations shall verify the materials submitted by enterprises and file those meeting the requirements; and notify enterprises that submit incomplete materials or the materials that do not fall under statutory circumstances of all necessary supplements on a one-off basis. All localities shall be encouraged to facilitate the handling of recordation formalities for enterprises by information technology means according to the overall requirements of “simplification of administrative procedures, decentralization of powers, combination of decentralization with appropriate control, and optimization of services” and in light of the actual local circumstances. 省級藥品監督管理部門應當對企業提交材料進行核對,符合要求的予以備案;提交材料不齊全或不符合法定情形的,應當一次性告知需要補充材料的事項。鼓勵各地按照國務院“放管服”的總體要求并結合當地實際,運用信息化手段為企業辦理備案手續提供便利。
          Provincial medical products administrations shall disclose the recordation information (Annex 3) to the public within seven working days after the recordation. The recordation information to be made public shall include enterprise names, legal representatives, website names, names of online Client apps, website domain names, website IP addresses, business permits for telecommunications services and the recordation numbers of non-operational Internet information services, and the recordation numbers of third-party platforms for online trading in medicinal products, among others. 省級藥品監督管理部門應當在備案后7個工作日內向社會公開備案信息(附件3)。公開的備案信息應包括:企業名稱、法定代表人、網站名稱、網絡客戶端應用程序名、網站域名、網站IP地址、電信業務經營許可證和非經營性互聯網信息服務備案編號、藥品網絡交易第三方平臺備案編號等。
          A provincial medical products administration shall, within three months after the recordation of a third-party platform for online trading in medicinal products, organize the on-site inspection of the third-party platform for online trading in medicinal products, and ensure that inspection is conducted at least once a year to direct the enterprise to conduct business operations in a legal and orderly manner. 省級藥品監督管理部門應當在藥品網絡交易第三方平臺備案后3個月內,組織對藥品網絡交易第三方平臺開展現場檢查,并確保每年至少開展1次檢查,引導企業合法有序開展經營。
          (3) Modification of recordation (三)變更備案
          Where the published recordation information on a third-party platform for online trading in medicinal products changes, the formalities for recordation modification shall be undergone with the provincial medical products administration within ten working days from the date of change of the relevant information; and if any other recordation information changes, it shall be updated in a timely manner. If a provincial medical products administration finds during the routine inspection that the recordation information of a third-party platform for online trading in medicinal products is inconsistent with the actual information, it shall urge and supervise the enterprise's updating of the recordation information in a timely manner. 藥品網絡交易第三方平臺的公示備案信息發生變化的,應當在相關信息變化之日起10個工作日內向省級藥品監督管理部門辦理變更備案;其他備案信息發生變化的,應及時進行更新。省級藥品監督管理部門在日常檢查中發現藥品網絡交易第三方平臺的備案信息與實際不符的,應督促企業及時更新備案信息。
          (4) Cancellation of recordation (四)取消備案
          If a third-party platform for online trading in medicinal products no longer provides the relevant services, it shall continuously publish relevant information in a conspicuous position on the home page of the platform 20 working days in advance, and take the initiative to undergo the recordation cancellation formalities with the provincial medical products administration at the place where it is located. The materials on recordation cancellation shall bear the official seal of the entity, and contain the recordation information to be cancelled and the commitment promising that no services of the third-party platform for online trading in medicinal products will be provided before recordation is obtained, among others. 藥品網絡交易第三方平臺不再開展相關業務的,應當提前20個工作日在平臺首頁顯著位置持續公示有關信息,主動向所在地省級藥品監督管理部門辦理取消備案。取消備案的材料需加蓋單位公章,內容應當包括擬取消的備案信息、未取得備案前不再開展藥品網絡交易第三方平臺服務的承諾聲明等。
          ...... 藥品網絡交易第三方平臺的實際情況與備案信息不符且無法取得聯系的,經省級藥品監督管理部門公示10個工作日后,仍無法取得聯系或無法開展現場檢查的,予以取消備案。
           ......



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