Article 1 According to the Advertising Law of the People's Republic of China (hereinafter referred to as Advertising Law), the Drug Administration Law of the People's Republic of China (hereinafter referred to as Drug Administration Law), the Rules for Implementing the Drug Administration Law of the People's Republic China (hereinafter referred to as Rules for Implementing the Drug Administration Law) and other related state provisions on the supervision and administration of advertisements and drugs, the present Measures are enacted with a view to strengthening the administration of drug advertisements (hereinafter referred to as drug ads) and guaranteeing the authenticity and legality of drug ads.

Article 2 All the ads containing drug names, applicable diseases (functions and indications) or other drug-related content and published through various media or in various forms belong to drug ads and shall be examined under the present Measures.

As regards a nonprescription drug ad that only publicizes the name of the drug (including the general name and commodity name) or a prescription drug ad that only publicizes the name of the drug (including the general name and commodity name) on designated professional publications of medicine science and pharmacy, the examination is not required.

Article 3 A drug ad for being examined may not pass the examination unless it complies with the following laws, regulations and related provisions:

(1) Advertising Law;

(2) Drug Administration Law;

(3) Rules for Implementing the Drug Administration Law;

(4) Standards for Examining and Issuing Drug Ads;

(5) Other state provisions on administrating ads.

Article 4 The drug administrative departments of the provinces, autonomous regions and municipalities directly under the Central Government shall be the examination organs of drug ads and shall, within their respective administrative regions, take charge of examining the drug ads. The administrative departments for industry and commerce at or above the county level shall be the supervisory and administrative organs of drug ads.

Article 5 The State Food and Drug Administration shall conduct guidance and supervision over the examination work of drug ads as made by the examination organs of drug ads, and shall, according to law, punish the examination organs for any violation of the present Measures.

Article 6 Only a qualified manufacturing or trading enterprise of the drug may file an application for a drug ad license number. In case a trading enterprise files such application, the consent of the manufacturing enterprise shall be obtained.

An applicant may entrust an agent to deal with the application matters for a drug ad license number on behalf of it.

Article 7 An application for a drug ad license number shall be filed with the examination organ of drug ads at the locality of the manufacturing enterprise of the drug.

An application for the ad license number of an import drug shall be filed with the examination organ of drug ads at the locality of the agency of the import drug.

Article 8 For applying for a drug ad license number, an applicant shall provide a Drug Ad Examination Form (Attached List 1), with the sample manuscript (film or tape) complying with the content to be published and the electronic document of the application form for drug ad attached, and, meanwhile, provide the following true, legal and effective evidentiary documents:

(1) Photocopy of the Business License of the applicant;

(2) Photocopy of the Drug Manufacturing License or Drug Trading License of the applicant;

(3) In case the applicant is a trading enterprise of the drug, the original evidentiary document on the fact that the manufacturing enterprise agrees to its status as applicant shall be submitted;

(4) Where the applicant entrusts an agent to apply for a drug ad license number, the original authorization letter produced by the applicant and the photocopy of the agent's business license and other evidentiary documents on the agent's subject status shall be provided;

(5) Photocopies of the drug approval certificates (including Registration Certificate for Import Drug and Registration Certificate for Medical Product), photocopy of the approved drug instructions as well as the label and instructions actually used;

(6) As regards a nonprescription drug ad, a photocopy of the examination and registration certificate of the nonprescription drug or photocopies of the related evidentiary documents shall be provided;

(7) For applying for the ad license number of an import drug, photocopies of the related evidentiary documents on the qualification of the drug import agency shall be provided;

(8) In case the ad involves the commodity name of the drug, the registered trademark or patent, etc., photocopies of the related evidentiary valid documents and other evidentiary documents confirming the authenticity of the content of the ad shall be provided.

Photocopy of any evidentiary document to be provided as provisioned in this Article shall be affixed with the seal of the entity holding it.

Article 9 An examination organ of drug ads may not accept an enterprise's application for ad of such drug under any of the following circumstances:

(1) Any of the circumstances under which the application may not be accepted as provisioned in Articles 20, 22 and 23 of the present Measures;

(2) The administrative procedure for revoking the drug ad license number is going on.

Article 10 Where the application materials are complete and satisfy the statutory requirements, an examination organ of drug ads shall issue a Notice of Drug Ad Acceptance after receiving an application for a drug ad license number, and, where they are not complete or fail to satisfy the statutory requirements, it shall, on the spot or within five workdays, inform the applicant of the content to be corrected once and for all; in case it fails to do so within the prescribed time limit, the day of the receipt of the application materials shall be deemed as the day of acceptance.

Article 11 An examination organ of drug ads shall examine the authenticity, legality and validity of the evidentiary documents provided by the applicant within 10 workdays since its acceptance of the application and examine the content of the ad in accordance with law. Where the drug ad passes the examination, it shall issue a drug ad license number; otherwise, it shall make a decision on rejecting issuing a drug ad license number, inform the applicant of the decision in written form and make explanations, and, meanwhile, inform the applicant of its right to apply for an administrative reconsideration or lodge an administrative lawsuit in accordance with law.

As regards an approved drug ad, the examination organ of drug ads shall report it to the State Food and Drug Administration for archival filling and send the approved Drug Ad Examination Form to the ad supervisory and administrative organ at the same level for archival filling. In case the State Food and Drug Administration finds any problem in the drug ad reported for archival filling, it shall order the examination organ of drug ads to make corrections.

The drug supervisory and administrative departments shall timely publicize the approved drug ads to the general public.

Article 12 The archive-filing formalities shall be gone through beforehand at the examination organ of drug ads of the place where the ad is to be published, if the drug ad is to be published in any province, autonomous region, or municipality directly under the Central Government other than the place where the manufacturing enterprise of the drug or the import drug agency is located (hereinafter referred to as publishing drug ad in any other place).

Article 13 For publishing any drug ad in any other place, the following materials shall be provided:

(1) Photocopy of the Drug Ad Examination Form;

(2) Photocopy of the approved drug instructions;

(3) For a TV or radio ad, a tape, CD or any other medium carrier with content identical with the content passing the examination shall be submitted;

The photocopy of any evidentiary document to be provided as provisioned in this Article shall be affixed with the seal of the entity holding it.

Article 14 As regards an application for the archive-filing of a drug ad published in any other place filed according to the provisions of Articles 12 and 13 of the present Measures, the examination organ of drug ads shall, within five workdays as of the acceptance of the archive-filing application, put it on record, endorse the word "Filed" on the Form, affix the special seal for the examination of drug ads and send a copy of the Form to the ad supervisory and administrative organ at the same level for future reference.

Where the examination organ of drug ads at the place where a drug ad is to be put on record holds that the drug ad fails to comply with the related provisions, it shall fill in the Opinion on the Archive-Filing of Drug Ads (Attached List 2) and send it to the original examination organ of drug ads for reexamination, and a copy thereof shall be sent to the State Food and Drug Administration.

The original examination organ shall inform the examination organ of drug ads at the place where the drug ad is to be put on record of its opinion within five workdays since the day when it receives the Opinion on the Archive-Filing of Drug Ads. In case the two examination organs of drug ads can't achieve a consensus, the State Food and Drug Administration may be invited to make a ruling thereon.

Article 15 A drug ad license number's valid period shall be one year, and once the period expires it shall become invalid.

Article 16 When publishing an approved drug ad, no content of the ad may be altered. In case it is necessary to alter any content, the drug ad license number shall be reapplied.