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Announcement of National Medical Products Administration on Matters relating to the Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial) ([2021] No.46)
Announcement of National Medical Products Administration (NMPA) on Matters relating to the Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial) ([2021] No.46)
In order to effectively implement the Implementing Measures for the Early Resolution Mechanism for Drug Patent Disputes (Trial) (hereinafter referred to as the “Measures”), the relevant matters are hereby announced as follows:
I. The China Patent Information Registration Platform for Marketed Drugs will be officially put into operation de dato. Relevant drug marketing authorization holders shall, as needed, complete the registration and voluntary disclosure of relevant drug patent information through the China Patent Information Registration Platform for Marketed Drugs in advance. If there is a need to change the relevant information registered and disclosed in the previous period, the marketing authorization holders shall update it in a timely manner. The relevant patent information that has been registered and disclosed shall serve as the basis for the applicant for registration of marketing of chemical generic drugs, traditional Chinese medicine (TCM) drugs of the same name and prescription and biosimilar drugs to make a patent statement. The registration platform and operation instructions can be referred to the website of the Center for Drug Evaluation, NMPA - China Patent Information Registration Platform for Marketed Drugs (website: https://zldj.cde.org.cn/home).
II. When an applicant submits the application for registration of marketing of chemical generic drugs, traditional Chinese medicine (TCM) drugs of the same name and prescription and biosimilar drugs, he shall refer to relevant drug patent information published on the China Patent Information Registration Platform for Marketed Drugs and submit a patent statement in accordance with the requirements of the Measures and notify the marketing authorization holder of the statement and the basis thereof de dato. If no patent statement is submitted, the application shall be accepted only after amendments are made. Please refer to the Operation Guide for Enterprises in the Pharmaceutical Business Application System (website: https://zwfw.nmpa.gov.cn) in the online business hall of NMPA.
The Announcement is hereby made.
Date: July 5, 2021
Source: China Patent Information Registration Platform for Marketed Drugs
