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