The hottest SFDA explains the regulations on the m

SFDA interprets the regulations on the administration of drug instructions and labels

on January 24, 2007, the State Food and Drug Administration issued the notice on the interpretation of relevant issues of the regulations on the administration of drug instructions and labels, with regard to the regulations on the administration of drug instructions and labels (Order No. 24 of the administration, hereinafter referred to as the regulations) (gsyjz [2006] No. 100) Some contents of the notice on further standardizing the management of drug names (gsyjz [2006] No. 99) are explained

the relevant issues specified in the notice include: supplementary application for modification of drug instructions and labels, use of drug names, use of trademarks, writing of indications in labels, marking of expiry date of labels in drugs, labels of APIs, 2 in labels, use of words and signs related to connecting the power source and starting the motor (power supply voltage 380V 50Hz), application of warnings, writing of excipients, etc

the notice also pointed out that the provisions on the administration of drug packaging, labeling and instructions (Provisional) had been repealed on June 1, 2006. Therefore, the detailed rules for the specification of drug instructions (Provisional) (gyjz [2001] No. 294) and the detailed rules for the specification of drug packaging and labeling (Provisional) (gyjz [2001] No. 482) formulated according to the provisions were repealed at the same time

in addition, according to the notice on the construction of information network for the supervision of narcotic drugs and psychotropic substances (gsyjian [2006] No. 169) issued by the State Food and drug administration, the labels of narcotic drugs and psychotropic substances can be marked with supervision codes. According to the Anti Doping regulations, if drugs contain banned substances listed in the doping catalogue, the instructions or labels should indicate the words "athletes should use with caution"

for the questions raised by various units in the implementation of the regulations, the State Food and Drug Administration will set up a special column for answering the order No. 24 at the Bureau station to continue to clarify and explain the relevant questions, with the number of employees of 8033

reproduced from: the State Food and Drug Administration

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