Drugs are special commodities. Prescription drugs can only be advertised in professional magazines, while OTC varieties can be advertised in public media, but they must apply for approval from the Food and Drug Administration in advance and obtain drug advertising approval. If you are interested, you can also refer to the application and approval process below.

Issuance of drug advertising approval number

1. Legal basis

1. "Advertising Law of the People's Republic of China"

2. "Drug Administration Law of the People's Republic of China"

3. "Regulations for the Implementation of the Drug Administration Law"

4. "Measures for the Examination of Drug Advertisements" (National Food and Drug Administration Order No. 27 of the State Administration for Industry and Commerce and the State Administration for Industry and Commerce)

5. "Standards for the Review of Drug Advertising" (Order No. 27 of the State Administration for Industry and Commerce and the State Food and Drug Administration)

< p>6. Relevant documents of the State Food and Drug Administration

2. Application conditions

1. Drugs produced by drug manufacturers or represented by provincial import drug agencies;

2. The applicant is a pharmaceutical manufacturing enterprise that holds a "Drug Production License" or a pharmaceutical operating enterprise that holds a power of attorney from the pharmaceutical manufacturing enterprise to handle advertising on its behalf.

3. Application materials

(1) To apply for publishing drug advertisements, you need to install the "Advertising Application Client" (see attachment 1 or go to the State Food and Drug Administration website www.sfda. gov.cn download), use this system to fill in the "Drug Advertising Review Form" and print out 5 copies; at the same time, submit the electronic version of the "Drug Advertising Review Form" export file in the form of a CD (see Appendix 2 for the filling and exporting method) and publish the advertising content Consistent electronic images (extension: .jpg); the handwriting of the advertising content should be clearly legible. Advertising samples, TV scripts or radio scripts must be printed and pasted or bound in the corresponding position in the table.

(2) Other materials (print a set on A4 paper, bind it into a volume in order, make a cover and catalog)

1. "Drug Production License" of the pharmaceutical manufacturer , a copy of the "Business License";

2. Copies of drug production approval documents, quality standards, and approved drug instructions for use (or stamped with the special seal of the Liaoning Provincial Food and Drug Administration for drug packaging label filing );

3. Unfold the drug sample packaging box (or design draft) and package instructions (or design draft) and paste them on A4 paper.

4. Over-the-counter drugs must submit a copy of the "Over-the-Counter Drug Registration Certificate" or the over-the-counter catalog document published by the State Food and Drug Administration;

5. The name of the drug appears in the advertising content , Registered trademarks, patents, etc. need to provide copies of relevant certification documents;

6. Imported drugs need to submit the "Import Drug Registration Certificate" or "Pharmaceutical Product Registration Certificate" and the corresponding qualifications of the imported drug agency Copies of certification documents;

7. If the applicant is a pharmaceutical business enterprise, it should submit copies of the "Business License", "Pharmaceutical Business License" and the original certification documents indicating that the pharmaceutical manufacturer agrees to be the applicant; When an advertising business unit or advertising publishing unit handles drug advertising applications on its behalf, it should submit a copy of the agency's "Business License" and the original letter of authorization from the pharmaceutical manufacturer;

8. Other confirmation of advertising content stipulated by laws and regulations Documents proving authenticity (such as authoritative certification materials involving product features in advertisements);

9. Original self-guarantee statement of the authenticity of administrative licensing (administrative confirmation) application materials (see attachment 3);< /p>

10. Copy of the handler’s ID card; if the handler is not the legal representative, a power of attorney for the legal representative should also be submitted;

11. Sound advertisements are also in the form of CDs Submit an audio file that is consistent with the content of the broadcast script;

12. The TV commercial script is produced in five columns: scene, scene duration, scene description, narration and subtitles. At the same time, submit the video files of the TV commercials in the form of a CD, one file for each commercial.

Note:

1. The above certification materials must be stamped with the official seal of the certificate holder or relevant unit. If there are any changes, change materials must be provided.

2. The following contents must be clearly marked in drug advertisements:

① The production approval number of the drug, and the name of the drug manufacturer or operating company;

< p>② Prescription drug advertisements must indicate "This advertisement is for medical and pharmaceutical professionals only"; over-the-counter drugs must indicate "Please follow the drug instructions or purchase and use under the guidance of a pharmacist" and the "OTC" logo);

< p>③ The approval number of the advertisement, such as Liaoyao Guangshen (document) No. XXXXXXXXXX;

④ If the advertisement involves patent content, the type and patent number of the patent need to be indicated;

⑤ Trademarks used in drug advertisements must be registered trademarks and may not be used without registration. When promoting registered trademarks, the common name of the drug must be used at the same time. In text advertisements and TV advertisements, the font size of a drug's trade name and product text-based registered trademark shall not be larger than the font used for the generic name of the drug.

4. Processing procedures

1. Application. The applicant submits a drug advertising application ("Drug Advertisement Review Form") and other application materials to the Administrative Licensing Office of the Liaoning Provincial Food and Drug Administration.

2. Acceptance. The application materials will be accepted and reviewed within 5 working days. If the application meets the requirements, it will be accepted and a notice of acceptance will be issued; if the application does not meet the requirements, a notice of rejection (supplementary materials) will be issued.

3. Review. The application materials will be reviewed in accordance with relevant regulations such as the Advertising Law, the Implementation Regulations of the Drug Administration Law, and the Measures for the Review of Drug Advertisements.

4. Decision. After review, if the regulations are met, the drug advertising approval number will be approved and issued; if the standards are not met, a decision will be made not to issue the drug advertising approval number, and the reasons will be stated in writing and the applicant will be notified.

5. Production and delivery of permission text. The provincial bureau acceptance office prepares and delivers the permission text ("Drug Advertising Review Form") with the drug advertising approval number.

5. Approval and delivery time limit

Approval time limit: 10 working days from the acceptance of the application to the date of decision on whether to agree to issue a drug advertising approval number.

Delivery time limit: The "Drug Advertising Review Form" will be delivered within 10 days from the date of approval and issuance of the drug advertising approval number.