Materials required for approval of over-the-counter drug advertising

1. 5 original copies of the "Drug Advertising Review Form";

2. "Over-the-counter Drug Review and Registration Certificate" and its A copy of the attachment (instructions for use) or a copy of relevant supporting documents

A copy of the drug registration certificate or drug registration approval document;

For imported drugs, an "Import Drug Registration Certificate" or A copy of the "Pharmaceutical Product Registration Certificate";

3. A copy of the applicant's "Business License";

4. The applicant's "Drug Production License" or "Pharmaceutical Business License" A copy of the license;

For imported drugs, a copy of the relevant qualification certification document of the imported drug agency is required;

5. The agent shall submit valid subject qualifications if handling on behalf of others Proof, such as a copy of the "Business License", etc.;

6. Other materials to prove the authenticity of the advertisement, such as the "Trademark Registration Certificate", if a patent is involved, please consult the Intellectual Property Office for the certification materials that must be submitted;

7. Actual drug instructions and packaging (flat on A4 paper);

8. If the advertisement is a video advertisement, a consistent sample should be provided and in MEPG format Copy it on a CD;

9. If the applicant is a pharmaceutical manufacturer, an original copy of the authorization letter from the legal person of the manufacturer to the person in charge should be provided;

The applicant is not the applicant. If the advertised drug is a manufacturer (including imported drugs), it should submit an original copy of the authorization letter from the production company to the applicant (no limit to the format), and an original copy of the authorization letter from the applicant's corporate legal person to the person in charge; < /p>

10. A floppy disk or CD exported from the advertising application review system software;

11. A self-guarantee statement on the authenticity of the application materials, and bear legal responsibility if the materials are false. Commitment; if you need to submit a floppy disk, you must also make a commitment to be responsible for the loss of data files caused by viruses;

Standards:

1. The application materials should be complete and clear, and the requirements Those who sign must sign, and each copy must be stamped with the official seal of the holding company. Use A4 paper to print or copy, and bind it into a volume according to the order of the application materials catalog;

2. One advertising application corresponds to an electronic advertising application document, and the name of the electronic version of the document should reflect the corresponding advertising application;

3. The electronic advertising application documents should be consistent with the content of the application materials.

Materials required for approval of prescription drug advertisements

1. 5 original copies of the "Drug Advertisement Review Form";

2. Copies of the drug registration certificate or drug registration approval document ;

Imported drugs need to provide a copy of the "Import Drug Registration Certificate" or "Pharmaceutical Product Registration Certificate";

3. A copy of the applicant's "Business License";

4. A copy of the applicant's "Drug Production License" or "Drug Business License";

For imported drugs, a copy of the relevant qualification certification documents of the import drug agency is required; < /p>

5. If the agent handles the matter on behalf of the agent, he/she should submit a valid qualification certificate of the subject, such as a copy of the "Business License";

6. Other materials proving the authenticity of the advertisement, such as the "Trademark" Registration Certificate". If a patent is involved, you should consult the Intellectual Property Office for the certification materials that must be submitted;

7. Actual drug instructions and packaging (printed flat on A4 paper);

8. If the advertisement is a video advertisement, a consistent sample should be provided and copied on a CD in MEPG format;

9. If the applicant is a pharmaceutical manufacturer, a copy of the legal person's statement from the manufacturer should be provided to the person in charge. An original copy of the authorization letter;

If the applicant is not the manufacturer of the drug for which the application is to be advertised (including imported drugs), an original copy of the authorization letter from the manufacturer to the applicant should be submitted (the format is not limited) , and an original copy of the authorization letter from the applicant's corporate legal person to the person in charge;

10. A floppy disk or CD exported from the advertising application review system software;

11. Application A self-guaranteed statement on the authenticity of the material, and a commitment to bear legal responsibility if the material is false; if a floppy disk is required, a commitment to be responsible for any loss of data files caused by viruses;

Standards:

1. Application materials should be complete and clear, and those requiring a signature must be signed. Each copy should be stamped with the official seal of the holding company. Use A4 paper to print or copy, and bind it into a volume according to the order of the application materials catalog;

2. One advertising application corresponds to an electronic advertising application document, and the name of the electronic version of the document should reflect the corresponding advertising application;

3. The electronic advertising application documents should be consistent with the content of the application materials.