Attachment: 1. "Measures for the Administration of Drug Advertising"; Chapter 1 General Provisions Article 1 is intended to strengthen the management of drug advertising (except veterinary drugs and pesticides) and ensure that drug promotion is true, scientific, accurate and provides reasonable guidance These measures are formulated in accordance with the relevant provisions of the "Drug Administration Law of the People's Republic of China" and the "Regulations on Advertising Administration". Article 2 All drug advertisements published within the territory of the People's Republic of China and the People's Republic of China using various media or forms shall fall within the scope of these Measures. Article 3 Pharmaceutical advertisements must strictly abide by the regulations on advertising management. False and unhealthy drug advertising is prohibited. Article 4: The administrative agencies for drug advertising are the industrial and commercial administration agencies at all levels, and the agencies for reviewing and approving the content of drug advertisements are the health administrative departments of the State Council and the health administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government. Chapter 2 Approval of Advertisements Article 5 Anyone who applies to publish drug advertisements must apply for the "Drug Advertisement Approval Form" from the health administrative department. The health administration department is responsible for reviewing the main ingredients, efficacy (function), indications (indications), usage, dosage, contraindications (precautions) and adverse reactions of the promoted drugs. Advertisements may not be published without review and approval. Article 6 Advertisers (including advertisers who produce and publish advertisements themselves, the same below) should submit the following certificates and materials to the health administrative department when applying for the "Drug Advertising Approval Form":
(1) "Drug Production Approval Form" Enterprise License" or "Pharmaceutical Business Enterprise License" (copy);
(2) "Enterprise Legal Person Business License" or "Business License" (copy);
(3) ) The production approval document, certificate of quality compliance, instructions, and packaging of the drug;
(4) Trademark registration certificate;
(5) Other relevant matters deemed necessary by the health administrative department Material. Article 7 The procedure for handling the Drug Advertising Approval Form is: the advertiser fills out the "Drug Advertising Approval Form" in five copies, and submits it together with relevant materials to the local (city, state, league) health administrative department for preliminary review and approval, and then reports to the province, autonomous region, or municipality directly under the Central Government. The health administrative department shall review and approve the application and issue a drug promotion approval number upon approval.
The health administrative department shall make a decision on whether to approve it within fifteen days after receiving all the materials; the approval time for foreign-related drug advertisements can be extended to thirty days. Article 8 If an advertiser holds a "Drug Advertising Approval Form" to publish the drug advertisement outside the area where it is located, it shall submit the "Drug Advertising Approval Form" to the health administrative department of the province, autonomous region, or municipality directly under the Central Government where it is released for record and cover 15 days before the release. No publication shall be made without registration and seal; except where the advertiser entrusts the local advertising business unit to publish the drug advertisement outside the local region. Article 9 The "Drug Advertisement Approval Form" shall be valid for two years from the date of approval. If you still need to continue advertising after expiration, you should apply again.
If the validity period of the "Drug Manufacturing Enterprise License" or "Drug Trading Enterprise License" is less than two years, the validity period of the "Drug Advertising Approval Form" shall be based on the validity period of the aforementioned license.
The format of the "Drug Advertising Approval Form" is formulated by the health administrative department of the State Council and uniformly printed by the health administrative departments of provinces, autonomous regions, and municipalities directly under the Central Government.
The unified format of the drug publicity approval number is: (abbreviation of province, autonomous region, municipality directly under the Central Government) Health Drug Xuanzi (year)... number. Article 10 Enterprises operating imported drugs that publish advertisements for imported drugs shall go through the approval procedures with the health administrative departments of the provinces, autonomous regions, and municipalities where they are located; foreign drug production and operating enterprises and their clients that apply to publish drug advertisements within the territory of our country shall submit to The health administrative department of the province, autonomous region, or municipality where its advertising agency is located shall handle the approval procedures.
The following documents and materials are required to be submitted when going through the above approval procedures:
(1) Certification documents approved by the country (region) that produces the drug;
(2) The "Import Drug Registration Certificate" (formerly the "Import Drug License") of the drug;
(3) The trademark registration certificate, instructions, and packaging of the drug (a Chinese translation should be attached);< /p>
(4) If entrusted to handle the examination and approval procedures, there should be a power of attorney from the foreign enterprise.
Pharmaceutical manufacturing and operating enterprises in Hong Kong and Macao shall refer to the provisions of this article.
Article 11 Advertisements for psychotropic drugs, toxic drugs, and radioactive drugs shall be approved by the health administration department of the State Council, and the health administration department of the province, autonomous region, or municipality directly under the Central Government where they are located shall issue a drug promotion approval number. Chapter 3 Management of Advertising Article 12 It is prohibited to publish the following drug advertisements:
(1) Narcotic drugs and psychotropic substances controlled by international conventions;
(2) Unsanitary drugs Drugs approved for production by administrative departments (including drugs for trial production);
(3) Drugs that have been banned from sale and use by the health administrative department;
(4) Drugs prepared by medical units preparation. Article 13 The meaning of language, text, and pictures in drug advertisements shall not exceed the content approved by the health administrative department on the "Drug Advertisement Approval Form". Article 14 Advertising operators must check the original copy of the "Drug Advertising Approval Form" and design, produce, publish, and agency advertisements according to the approved content. Advertising operators are not allowed to undertake or represent unapproved pharmaceutical advertisements. Article 15: When advertising pharmaceuticals using television, radio, newspapers, magazines and other printed materials as well as street signs, the drug promotion approval number shall be listed as the content of the advertisement and published at the same time.
When using the media mentioned in the preceding paragraph to publish advertisements for drugs recommended for personal use, the content of the advertisement must include words of advice to patients: "Please use under the guidance of a doctor."
Drug promotion approval number shall not be printed on the packaging, labels and instructions of the drug. The drug promotion approval number and the "Drug Advertisement Approval Form" may not be transferred, rented or borrowed.