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Forwarding the notice on strengthening the implementation of the provisions on the administration of drug instructions and labels

Date:2020-03-02

Gsyjb [2007] No. 311


Food and Drug Administration of each province, autonomous region and municipality directly under the central government (Drug Administration):


On March 15, 2006, the State Administration promulgated the regulations on the administration of drug instructions and labels (Order No. 24 of the State Administration, hereinafter referred to as order No. 24). Since then, in view of the actual situation of the replacement of instructions and labels by enterprises, relevant supporting documents have been successively issued to give a more specific explanation to order No. 24, and at the same time, the transitional period policy has been stipulated. At present, order 24 is about to enter into a comprehensive implementation stage. In order to further strengthen the implementation, supervision and management of order 24, and ensure the smooth and orderly completion of the replacement of labels and instructions in the production and circulation of drugs, we hereby notify the following matters:


1、 According to the requirements of the announcement on relevant matters of the regulations on the administration of drug instructions and labels (gsyjz [2006] No. 100), the instructions and labels of all drugs manufactured from June 1, 2007 (subject to the production date) shall meet the requirements of order 24.


Due to technical reasons, some enterprises declare late, and the provincial drug regulatory authorities have not completed the audit. In view of this special provision, drug manufacturers have submitted supplementary applications to the provincial drug regulatory authorities before June 1, 2007 to modify the drug instructions and labels. If the provincial drug regulatory authorities have not completed the review, each review department shall seize the time to conduct centralized review and complete the review before July 1, 2007.


Before June 1, 2007, the drug manufacturing enterprise shall submit a supplementary application to the provincial drug regulatory department for modifying the drug instructions and labels. The drugs manufactured before October 1, 2007 can continue to use the original labels and instructions.


If the drug manufacturer fails to apply to the provincial drug regulatory authority for amending the drug specification and label supplement before June 1, 2007, the original label and label supplement shall not be used for drugs leaving the factory since June 1, 2007.


2、 In the process of implementing order 24, the local drug regulatory authorities at all levels shall strictly administer according to law, guide and urge the enterprises to consciously abide by order 24, and timely communicate with the provincial drug regulatory authorities where the drug manufacturer is located in case of any suspected illegal act (for imported drugs, timely communicate with the National Bureau), so as to review the recorded instructions and labels On the basis of this, the illegal acts shall be corrected in time.


3、 According to the provisions of Article 54 of the drug administration law, drug packages must be printed or pasted with labels and instructions in accordance with the provisions. Order No. 24 makes further clear provisions on drug packaging labels, among which Article 3 of the provisions on the approval of drug specifications and labels, Article 24 of the provisions on drug names, and Article 27 of the provisions on drug trademarks are aimed at strengthening the management of drug specifications and labels, emphasizing that drug specifications, generic names and trade names should be strictly in accordance with the drug The procedures prescribed by the laws and regulations on quality management shall be examined and approved. Any text, mark and other information in the drug manual and label shall not expand or imply the efficacy of the drug, mislead consumers, and strive to solve the negative impact of "more than one drug". Drug regulatory authorities at all levels shall strengthen the examination, supervision and management of drug instructions and labels according to law. Drug instructions and labels shall not be used without the approval of drug regulatory authorities. We will investigate and deal with the acts that violate the provisions of the administrative license law, the drug administration law, the regulations for the implementation of the drug administration law and order 24, such as the use of labels and instructions without approval, the addition of indications or the treatment of functions without authorization.


In the process of implementing No. 24 order and relevant regulations, local drug regulatory authorities shall report new situations and problems to the State Administration in time.


State Food and Drug Administration

May 31, 2007


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