Article 1 In order to strengthen the administration of drug advertisements and ensure the authenticity and legality of drug advertisements, according to the Advertising Law of People's Republic of China (PRC) (hereinafter referred to as the Advertising Law), the Drug Administration Law of People's Republic of China (PRC) (hereinafter referred to as the Drug Administration Law) and the Implementation Regulations of People's Republic of China (PRC) Drug Administration Law (hereinafter referred to as the Implementation Regulations of the Drug Administration Law).
Article 2 Advertisements containing drug names, drug indications (functional indications) or other drug-related contents published through various media or forms belong to drug advertisements and shall be reviewed in accordance with these Measures.
Over-the-counter drugs only promote drug names (including generic names and trade names), or prescription drugs only promote drug names (including generic names and trade names) and publish them in designated medical and pharmaceutical journals without review.
Article 3 A drug advertisement applying for examination shall comply with the following laws, regulations and relevant provisions before it can pass the examination:
(1) advertising law;
(2) Drug Administration Law;
(3) Regulations on the Implementation of the Drug Administration Law;
(4) Standards for the examination and publication of drug advertisements;
(five) other provisions of the state on advertising management.
Article 4 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government are drug advertisement examination organs, which are responsible for the examination of drug advertisements within their respective administrative areas. The administrative department for industry and commerce at or above the county level is the supervision and administration organ of drug advertisements.
Article 5 The State Food and Drug Administration of the United States shall guide and supervise the drug advertisement examination work of the drug advertisement examination organ, and deal with the violation of these Measures by the drug advertisement examination organ according to law.
Article 6 The applicant for the drug advertisement approval number must be a legally qualified drug production enterprise or drug trading enterprise. As an applicant, a pharmaceutical trading enterprise must obtain the consent of the pharmaceutical production enterprise.
An applicant may entrust an agent to apply for a drug advertisement approval number.
Article 7 An application for a drug advertisement approval number shall be submitted to the drug advertisement examination organ where the drug production enterprise is located.
The application for the approval number of imported drug advertisements shall be submitted to the drug advertisement examination organ where the imported drug agency is located.
Article 8 To apply for a drug advertisement approval number, the applicant shall submit a drug advertisement examination form (form 1), samples (samples and tapes) consistent with the published contents, and an electronic document of the drug advertisement application form, and at the same time submit the following authentic, legal and effective documents:
(1) A copy of the applicant's business license;
(2) A copy of the applicant's Pharmaceutical Production License or Pharmaceutical Trading License;
(3) If the applicant is a pharmaceutical trading enterprise, it shall submit the original documents certifying that the pharmaceutical production enterprise agrees to be the applicant;
(4) Where an agent applies for the drug advertisement approval number on his behalf, it shall submit the original power of attorney of the applicant and a copy of the agent's business license and other subject qualification documents;
(5) A copy of the drug approval certificate (including the registration certificate of imported drugs and the registration certificate of pharmaceutical products), a copy of the approved instructions, and the labels and instructions for actual use;
(6) A copy of the Non-prescription Drug Examination and Registration Certificate or relevant certification documents shall be submitted for the advertisement of non-prescription drugs;
(seven) to apply for the approval number of the imported drug advertisement, it shall provide a copy of the relevant qualification documents of the imported drug agency;
(8) If the advertisement involves drug trade names, registered trademarks, patents, etc., copies of relevant valid certification documents and other certification documents confirming the authenticity of the advertisement contents shall be submitted.
To provide a copy of the certification documents specified in this article, it is necessary to affix the seal of the certification holder.
Article 9 Under any of the following circumstances, the drug advertisement examination organ shall not accept the enterprise's application for drug advertisement of this variety:
(a) the provisions of article twentieth, article twenty-second and article twenty-third of these measures shall not be accepted;
(2) The administrative procedure for revoking the drug advertisement approval number is being implemented.
Article 10 After receiving the application for drug advertisement approval number, the drug advertisement examination organ shall issue a Notice of Acceptance of Drug Advertisement if the application materials are complete and meet the statutory requirements; If the application materials are incomplete or do not meet the statutory requirements, the applicant shall be informed of all the contents that need to be corrected on the spot or within 5 working days; Fails to inform, since the date of receipt of the application materials is accepted.
Article 11 The drug advertisement examination organ shall, within 10 working days from the date of acceptance, examine the authenticity, legality and validity of the certification documents submitted by the applicant, and examine the contents of the advertisement according to law. For drug advertisements that pass the examination, a drug advertisement approval number shall be issued; For drug advertisements that fail to pass the examination, a decision shall be made not to issue the approval number of drug advertisements, and the applicant shall be informed in writing and the reasons shall be explained. At the same time, the applicant shall be informed of the right to apply for administrative reconsideration or bring an administrative lawsuit according to law.
The drug advertisement examination organ shall report the approved drug advertisement to the State Food and Drug Administration for the record, and send the approved drug advertisement examination form to the advertising supervision and administration organ at the same level for the record. The State Food and Drug Administration of the United States shall instruct the drug advertisement examination organ to correct the drug advertisements with problems in filing.
The drug supervision and administration department shall announce the approved drug advertisements to the public in a timely manner.
Article 12 Where a pharmaceutical advertisement is published in a province, autonomous region or municipality directly under the Central Government other than the place where a pharmaceutical production enterprise is located or where an imported pharmaceutical agency is located (hereinafter referred to as "drug advertisement published in different places"), it shall be filed with the drug advertisement examination organ at the place where it is published.
Article 13 The following materials shall be submitted for the filing of drug advertisements published in different places:
(1) A copy of the Drug Advertisement Examination Form;
(2) a copy of the approved drug instructions;
(3) For TV advertisements and radio advertisements, audio tapes, CDs or other media carriers that are consistent with the contents examined and approved shall be submitted.
To provide a copy of the materials specified in this article, the seal of the certificate holder shall be affixed.
Article 14 The drug advertisement examination organ shall, within five working days after accepting the application for filing, file the application for publishing drug advertisements in different places in accordance with the provisions of Articles 12 and 13 of these Measures, sign "Recorded" on the Drug Advertisement Examination Form, affix the special seal for drug advertisement examination, and send it to the advertising supervision and administration organ at the same level for future reference.
Where the drug advertisement examination organ at the place of filing considers that the drug advertisement does not conform to the relevant provisions, it shall fill in the Opinion on Drug Advertisement Filing (Table 2), submit it to the original approved drug advertisement examination organ for examination, and send a copy to the State Food and Drug Administration of the United States.
The drug advertisement examination organ that originally approved it shall inform the drug advertisement examination organ at the place of filing within 5 working days after receiving the Opinion of Drug Advertisement Filing. If the opinions of the original drug advertisement examination organ and the drug advertisement examination organ at the place of filing cannot reach an agreement, it may be reported to the State Food and Drug Administration for a ruling.
Article 15 The validity period of the drug advertisement approval number is 1 year, and it will become invalid upon expiration.
Article 16 The contents of an approved drug advertisement shall not be changed. If the contents of drug advertisements need to be changed, it shall re-apply for the approval number of drug advertisements.
Article 17 Where an advertising applicant publishes a drug advertisement on his own, he shall keep the original Drug Advertisement Examination Form for 2 years for future reference.
Advertisers and advertising agents who are entrusted by advertising applicants to publish drug advertisements shall review the original Drug Advertisement Examination Form and publish it according to the contents approved by the examination. A copy of the Drug Advertisement Examination Form shall be kept for 2 years for future reference.
Article 18 If an approved drug advertisement is under any of the following circumstances, the original drug advertisement examination organ shall issue a Notice of Drug Advertisement Examination to the applicant for examination. During the review period, the drug advertisement can continue to be released.
(1) The State Food and Drug Administration of the United States considers that the contents of drug advertisements approved by the drug advertisement examination organ are not in conformity with the provisions;
(two) the advertising supervision and administration organs at or above the provincial level put forward examination suggestions;
(3) Other circumstances that the drug advertisement examination organ thinks should be examined.
Upon examination, if it is found that it does not meet the statutory requirements, the Drug Advertisement Examination Form shall be withdrawn, and the original drug advertisement approval number shall be invalid.
Article 19 Under any of the following circumstances, the drug advertisement examination organ shall revoke the drug advertisement approval number:
(1) The Pharmaceutical Production License and Pharmaceutical Business License have been revoked;
(2) The drug approval certificate has been revoked or cancelled;
(3) Drugs whose production, sale and use have been ordered by the US Food and Drug Administration or the drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government to stop.
Article 20 Whoever falsifies the contents of an approved drug advertisement to make false propaganda shall be ordered by the drug supervision and administration department to immediately stop publishing the drug advertisement, revoke the approval number of the drug advertisement of this variety, and refuse to accept the application for advertising approval of this variety within 1 year.
Article 21 If illegal advertisements are found that expand the scope of product indications (functional indications) without authorization, absolutely exaggerate the efficacy of drugs, and seriously deceive and mislead consumers, the pharmaceutical supervisory and administrative departments at or above the provincial level shall take administrative compulsory measures to suspend the sales of the drugs within their respective jurisdictions, and at the same time order enterprises that illegally publish drug advertisements to publish correction announcements in the corresponding local media. After an enterprise that illegally publishes drug advertisements issues a notice of correction as required, the drug supervision and administration department at or above the provincial level shall make a decision to lift the administrative compulsory measures within 15 working days; If it is necessary to conduct drug inspection, the pharmaceutical supervisory and administrative department shall make a decision on whether to lift the administrative compulsory measures within 05 days from the date of issuing the inspection report.
Article 22 If the drug advertisement examination organ finds an application for drug advertisement examination and approval that provides false materials during the acceptance examination, it will not accept the application for drug advertisement examination and approval of the enterprise within 1 year.
Article 23 Where a drug advertisement approval number is obtained by providing false materials to apply for drug advertisement approval, the drug advertisement examination organ shall revoke the drug advertisement approval number after discovery, and shall not accept the drug advertisement approval application of the enterprise within three years.
Article 24 In accordance with the provisions of Articles 18, 19, 20 and 23 of these Measures, the publication of drug advertisements whose approval number has been revoked, cancelled or revoked must be stopped immediately; The drug advertisement examination organ in different places stops accepting the advertisement filing of the drug advertisement approval number of the enterprise.
If the drug advertisement examination organ revokes, cancels or revokes the drug advertisement approval number according to Articles 18, 19, 20 and 23 of these Measures, it shall notify the advertising supervision and administration organ at the same level within 5 working days from the date of making the administrative decision, and the advertising supervision and administration organ shall handle it according to law.
Article 25 If a drug advertisement released in a different place has not been filed with the drug advertisement examination organ in the place where it was released, the drug advertisement examination organ in the place where it was released shall order it to go through the filing formalities within a time limit, and if it is not corrected within the time limit, the advertising activities of the drug variety in the place where it was released shall be stopped.
Twenty-sixth pharmaceutical supervisory and administrative departments at or above the county level shall supervise and inspect the drug advertisements published after examination and approval. For illegal drug advertisements, the drug supervision and administration departments at all levels shall fill in the Notice of Transfer of Illegal Drug Advertisements (Annex 4) and transfer it to the advertising supervision and administration organs at the same level for investigation. Tampering with the approved drug advertisements published in different places, the drug advertisement examination organ at the place of publication shall also put forward a proposal to revoke the approval number of drug advertisements in accordance with the provisions of Article 92 of the Drug Administration Law and Article 20 of these Measures.
Article 27 The drug supervision and administration departments of provinces, autonomous regions and municipalities directly under the Central Government shall announce the advertisements of illegal drugs with serious circumstances, and report them to the State Food and Drug Administration in time, which will be summarized and published regularly by the State.
If the circumstances of publishing false and illegal drug advertisements are serious, the State Administration for Industry and Commerce shall jointly publish them with the State Food and Drug Administration when necessary.
Article 28 Where a drug advertisement is published without examination and approval, or the published drug advertisement is inconsistent with the contents examined and approved, the advertising supervision and administration organ shall punish it in accordance with the provisions of Article 43 of the Advertising Law; Those who constitute false advertisements or misleading false propaganda shall be punished by the advertising supervision and administration organs according to Article 37 of the Advertising Law and Article 24 of the Anti-Unfair Competition Law.
When investigating illegal drug advertising cases, the advertising supervision and administration organ shall notify the drug supervision and administration department at or above the provincial level of the contents that need to be identified, and the drug supervision and administration department at or above the provincial level shall feed back the identification results to the advertising supervision and administration organ within 10 working days after receiving the notice.
Article 29 Drug advertisement examiners and drug advertisement supervisors shall receive training in advertising law, drug administration law and other relevant laws and regulations. Any staff member of the drug advertisement examination organ or the drug advertisement supervision and administration organ who neglects his duty, abuses his power or engages in malpractices for personal gain shall be given administrative sanctions. If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 30 The approval numbers of drug advertisements are "X Yao Guang Shen Zi No.0000000", "X Yao Guang Shen Zi No.00000000" and "X Yao Guang Shen Zi No.00000000". Where "X" is the abbreviation of all provinces, autonomous regions and municipalities directly under the Central Government. "0" consists of 10 digits, with the first 6 digits representing the year of review and the last 4 digits representing the advertisement approval number. "Vision", "sound" and "text" represent the classification codes used in the form of advertising media.
Article 31 These Measures shall be implemented as of May 6, 2007. 1On March 22, 995, the Measures for the Examination of Drug Advertisements issued by the State Administration for Industry and Commerce and the Ministry of Health (Order No.25 of the State Administration for Industry and Commerce) shall be abolished at the same time.