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Government Documents
Government Documents
UPDATED: June 11, 2008 NO. 19 MAY 8, 2008
Measures for Examining Drug Advertisements
Promulgated by the State Food and Drug Administration, the State Administration of Industry and Commerce on March 13, 2007 and effective as of May 1, 2007
 
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Article 17 In case a drug ad applicant publishes the drug ad by itself, the original Drug Ad Examination Form shall be kept for two years for future reference.

In case an ad publisher or operator is entrusted by a drug ad applicant to act as an agent or publish the drug ad, it shall check the original Drug Ad Examination Form, publish the drug ad on the basis of the examined and approved content, and keep the photocopy of the Form for two years for future reference.

Article 18 Where an approved drug ad falls within any of the following circumstances, the original examination organ of the drug ad shall issue a Notice on the Reexamination of Drug Ads (Attached List 3) to the applicant of the drug ad and reexamine the drug ad in accordance with law. The drug ad may be continued to publish during the reexamination period:

(1) The State Food and Drug Administration holds that the content of the approved drug ad fails to comply with the related provisions;

(2) An ad supervisory and administrative organ at the provincial level or above suggests the reexamination of the drug ad;

(3) Any other circumstance under which the examination organ of drug ads holds that it is necessary to reexamine.

Where, upon reexamination, the original examination organ of drug ads holds that the drug ad fails to meet the statutory conditions, it shall take back the Drug Ad Examination Form and cancel the original drug ad license number.

Article 19 The examination organ of drug ads shall write-off the drug ad license number under any of the following circumstances:

(1) The Drug Manufacturing License or Drug Trading License has been canceled;

(2) The approval certifications on the drug have been cancelled or written off;

(3) The State Food and Drug Administration or the drug supervisory and administrative department of the province, autonomous region, or municipality directly under the Central Government has ordered to suspend the production, sale and use of the drug.

Article 20 In case false publicity is made by altering an approved drug ad's content without authorization, the drug supervisory and administrative department shall order to stop such publishing immediately, revoke the ad license number of such drug and may not accept the application for the examination and approval of any ad on such drug within one year.

Article 21 As regards any illegal drug ad that enlarges the scope of applicable diseases (functions and indications) of the drug at will, absolutely exaggerates the curative effects of the drug and severely cheats and misleads the consumers, once the drug supervisory and administrative department at the provincial level or above finds, an administrative coercive measure shall be adopted to suspend the sale of such drug within its jurisdiction and, meanwhile, order the enterprise illegally publishing the drug ad to publish a notice of correction on the corresponding local media. The drug supervisory and administrative department at the provincial level or above shall, within 15 workdays, make a decision on lifting the administrative coercive measure after the notice is published; in case it is necessary to check the drug, the drug supervisory and administrative department shall, within 15 days since the day when the written check report is sent, make a decision on whether to lift the administrative coercive measure or not.

Article 22 As regards an enterprise providing any false application material for the examination and approval of a drug ad, once the examination organ of drug ads finds during the acceptance or examination, this enterprise's application for the examination and approval of any ad on such drug may not be accepted within one year.

Article 23 In case an enterprise obtains a drug ad license number by submitting false application materials, the examination organ of drug ads shall, after finding, revoke the drug ad license number and may, within three years, not accept this enterprise's application for the examination and approval of any ad on such drug.

Article 24 In case the license number of a drug ad has been taken back, written off or cancelled according to Articles 18, 19, 20 or 23 of the present Measures, the publication thereof shall be stopped at once; the examination organ of drug ads of any other place shall stop accepting such enterprise's application for the archive-filing of such drug ad's approved license number.

In case an examination organ of drug ads decides to take back, write off or cancel a drug ad license number according to Articles 18, 19, 20 or 23 of the present Measures, it shall inform the ad supervisory and administrative organ at the same level to deal with it in accordance with law within five workdays since the day when it makes such administrative handling decision.

Article 25 In case an enterprise publishes a drug ad in other place without sending an archive-filing application to the examination organ of drug ads at the place where the drug ad is published, once it is found out, it shall be ordered to go through the formalities for archive-filing within a prescribed period. Where it fails to do so, the publishing activities of such drug ad shall be ordered to be stopped in that place.

Article 26 The drug supervisory and administrative departments at the county level or above shall monitor and inspect the publication of the examined and approved drug ads. As regards the illegally published drug ads, the drug supervisory and administrative departments at each level shall fill in the Notice on Transferring Illegal Drug Ads (Attached List 4) and transfer them together with such materials as the sample pieces of these illegal drug ads to the ad supervisory and administrative organs at the same level for investigating and handling; as regards an other-place publication of a drug ad with approved content altered without authorization, the examination organ of drug ads at the place where the drug ad is published shall, according to Article 92 of the Drug Administration Law and Article 20 of the present Measures, put forward a suggestion on revoking the license number of the drug ad to the original examination organ of drug ads.

Article 27 As regards any illegal drug ad with serious circumstance, the drug supervisory and administrative department of the province, autonomous region or municipality directly under the Central Government shall publicize an announcement thereon and report it to the State Food and Drug Administration, which shall, on a consolidated and regular basis, publicize such reports.

As regards any illegal drug ad with serious circumstance, when necessary, the State Administration for Industry and Commerce and the State Food and Drug Administration shall jointly publicize an announcement thereon.

Article 28 In case a drug ad is published without being examined and approved or the content of a published drug ad is inconsistent with the examined and approved one, the ad supervisory and administrative organ shall punish according to Article 43 of the Advertising Law; in case it constitutes a false ad or a false and misleading publicity, the ad supervisory and administrative organ shall punish according to Article 37 of the Advertising Law and Article 24 of the Anti-Unfair Competition Law.

In case the ad supervisory and administrative organ, when investigating and punishing a case of illegal drug ad, finds it is necessary to determine certain professional technical content as involved in the case, it shall send a written notice on the content to be determined to the drug supervisory and administrative department at the provincial level or above, which shall, within 10 workdays since the day when the notice is received, feed back the determination result to the ad supervisory and administrative organ.

Article 29 The working personnel assuming the examination and supervision of drug ads shall be subject to the training on the Advertising Law, the Drug Administration Law and other related laws and regulations. In case any working personnel of the examination organs of drug ads and the supervisory and administrative organs thereof neglects his duties, abuses his power or conducts any self-exerting misconduct, administrative punishment shall be imposed. In case any crime is established, criminal liabilities shall be ascertained.

Article 30 A drug ad license number shall be in the form of "No.0000000000 of X Drug Ad Examination (Video)," "No.0000000000 of X Drug Ad Examination (Audio)" or "No.0000000000 of X Drug Ad Examination (Words)," among which, "X" means the abbreviation of a province, autonomous region or municipality directly under the Central Government, "0" consists of 10 digits, the first six shall be the date when the examination is conducted and the last four shall be the approved ad's serial number. "Video," "Audio" and "Words" indicate the medium forms for publishing ads.

Article 31 The present Measures shall go into effect as of May 1, 2007. The Measures for Examining Drug Ads (No.25 of the State Administration for Industry and Commerce), which were promulgated by the State Administration for Industry and Commerce and the Ministry of Public Health on March 22, 1995, shall be repealed at the same time.

(Source: www.fdi.gov.cn)

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