Industry standard: the standard pharmaceutical packaging and printing the same –
From the State Food and Drug Monitoring Control Bureau, Beijing Municipal Bureau of Food and Drug Monitoring Control Registry, Marketing Division, Beijing drug kits? Materials, maintenance and other related agencies are aware of: printing packaging material that is printed product information (package insert drugs and Bonded Label ) Print Scale based upon the March 15, 2006 promulgated the "drug labeling and label management designated" (ie the State Food and Drug Monitoring Control Board Order No. 24) Executive.
Related printed scale policy: States Food and Drug Monitoring Control Board Order No. 24, "the drug labeling and label management designated" on March 10, 2006 by the State Secretary for Food and Drug Monitoring Management Services Council, is hereby declared that, since 2006 into effect on June 1.
Chapter I General Provisions The first to regulate drug labeling, and labeling of governance, according to "The People's Republic of China Drug Control Law", and "The People's Republic of China Drug Control Law Implementation Regulations," the development of the demarcation.
Second listing in the PRC Sell Drugs, the package insert and labeling shall conform to the requirements delineated.
Third drug labeling and labeling of surveillance by the State Food and Drug Control Council approval.
That labeling should be based on imitation alone, its contents shall not exceed the scope of a single simulation may not be printed imply efficacy, misleading and inappropriate use of text and logo promotional products.
Article IV drugs Package Required in accordance with the designated printed on or affixed with labels, not entrainment He Xianrong or any other promotional products, business text, audio and other information. Drugs produced in enterprises producing for sale with the least packaging necessary to imitate one. Article
label drug labeling and the textual representation should be scientific, standard and correct. Non-prescription drug package insert should also be easily understood using the textual representation, in order to determine their own patients, selection and use.
Article VI of the drug labeling and label text should be clear to distinguish, logo should be clear and conspicuous, not a printing paste is not strong off or phenomena, not to paste, cut, modify or alter, etc. added.
Article VII of the drug labeling and labels should use the State Language Work Committee announced that the standardization of Chinese characters, to increase the control of other characters, character expression should prevail.
Article VIII for the protection of public health and the fair and accurate guidance of the purpose of medication, drug companies can produce in the drug labeling initiative or notation on the label warnings, the State Food and Drug Monitoring Control Board can also require companies producing fake drugs Single or notation on the label warnings.
Chapter II drug labeling Article drug labeling should include drug safety, efficacy, an important scientific data, conclusions and information to guide the safe and fair use of drugs. The detailed pattern of drug labeling, content and writing requirements by the State Food and Drug Monitoring Control Board to develop and publish. Article
disease name drug labeling, pharmacy professional terms, drug names, names and maintenance of clinical presentation of the results, should be promulgated by the State or regulations of the same special vocabulary, units of measurement shall conform to the designated scale.
Article shall be listed in the drug labeling all of the active ingredient or group of all prescription medicine . Injection and non-prescription drugs to fight should also list the name used by all the accessories.
Prescription drugs may cause severe adverse reactions with the ingredients or excipients, should be explained.
Article XII enterprises should take the initiative to track the drugs produced in post-marketing safety of drugs, the effectiveness of circumstances, need to revise the drug labeling, it shall apply.
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