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SAMR | Replacement of Formulation & Label information of FSMP after Registration Alteration


May 02, 2020


Sate Administration for Market Regulation (SAMR) replied Shanghai Municipal Administration for Market Regulation on the time limit of replacing label information of Food for Special Medical Purposes (FSMP) (after registration alteration), as follows:

According to relevant provisions of Food Safety Law and Administrative Measures for Registration of Food for Special Medical Purposes, under the premise of ensuring a scientific and safe formulation of FSMP, in order to avoid the unnecessary waste, the applicant shall complete the replacement of formulation and label information within 3 months from the date of approval of alteration of formulation and label. After the replacement, the applicant shall not continue using the previous formulation and label, and report the replacement to local administration for market regulation. FSMP manufactured before the replacement is allowed to be sold till the expiration date.
The detailed information in Chinese, å¸‚场监管总局关于特殊医学用途配方食品变更注册后产品配方和标签更替问题的复函


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