1, 5 originals of the drug advertisement review form;
2, "non prescription drug registration certificate" and its attachments (instructions) or a copy of the relevant documents.
Copy of drug registration certificate or drug registration approval;
A copy of the Registration Certificate for Imported Drugs or the Registration Certificate for Pharmaceutical Products shall be provided for imported drugs;
3. A copy of the applicant's business license;
4, the applicant's "drug production license" or "drug business license" copy;
For imported drugs, a copy of the relevant qualification certification documents of the imported drug agency shall be provided;
5. If the agent is subrogated, it shall submit a copy of the business license and other valid qualification certificates;
6. Trademark registration certificate and other materials to prove the authenticity of the advertisement, as well as the certification materials that should be submitted when applying for a patent to the Intellectual Property Office;
7, the actual use of drugs and packaging (flat on A4 paper);
8. If the advertisement is a video advertisement, it shall provide a sample consistent with it and copy it on the CD in MEPG format;
9. If the applicant is a pharmaceutical production enterprise, it shall provide the original power of attorney of the legal person of the production enterprise to the agent;
If the applicant is not a manufacturer applying for advertising drugs (including imported drugs), it shall submit the original power of attorney of the manufacturer to the applicant (the format is not limited) and the original power of attorney of the applicant as an enterprise legal person to the agent;
10, floppy disk or CD exported by the software of the advertisement application review system;
1 1. Apply for the self-assurance statement of the authenticity of the materials, and promise to bear legal responsibility for the falsehood of the materials; If you need to submit a floppy disk, promise to be responsible for the loss of data files caused by the virus;
Standard:
1. The application materials shall be complete and clear. If signature is required, it shall be signed, and each copy shall be stamped with the official seal of the holding enterprise. Print or copy it on A4 paper, and bind it into volumes in the order of the application materials catalogue;
2. An advertising application corresponds to an electronic advertising application file, and the name of the electronic file should reflect the corresponding advertising application;
3, electronic advertising application documents should be consistent with the application materials.
Materials to be submitted for the approval of prescription drug advertisements
1, 5 originals of the drug advertisement review form;
2, a copy of the drug registration certificate or drug registration approval;
A copy of the Registration Certificate for Imported Drugs or the Registration Certificate for Pharmaceutical Products shall be provided for imported drugs;
3. A copy of the applicant's business license;
4, the applicant's "drug production license" or "drug business license" copy;
For imported drugs, a copy of the relevant qualification certification documents of the imported drug agency shall be provided;
5. If the agent is subrogated, it shall submit a copy of the business license and other valid qualification certificates;
6. Trademark registration certificate and other materials to prove the authenticity of the advertisement, as well as the certification materials that should be submitted when applying for a patent to the Intellectual Property Office;
7, the actual use of drugs and packaging (flat on A4 paper);
8. If the advertisement is a video advertisement, it shall provide a sample consistent with it and copy it on the CD in MEPG format;
9. If the applicant is a pharmaceutical production enterprise, it shall provide the original power of attorney of the legal person of the production enterprise to the agent;
If the applicant is not a manufacturer applying for advertising drugs (including imported drugs), it shall submit the original power of attorney of the manufacturer to the applicant (the format is not limited) and the original power of attorney of the applicant as an enterprise legal person to the agent;
10, floppy disk or CD exported by the software of the advertisement application review system;
1 1. Apply for the self-assurance statement of the authenticity of the materials, and promise to bear legal responsibility for the falsehood of the materials; If you need to submit a floppy disk, promise to be responsible for the loss of data files caused by the virus;
Standard:
1. The application materials shall be complete and clear. If signature is required, it shall be signed, and each copy shall be stamped with the official seal of the holding enterprise. Print or copy it on A4 paper, and bind it into volumes in the order of the application materials catalogue;
2. An advertising application corresponds to an electronic advertising application file, and the name of the electronic file should reflect the corresponding advertising application;
3, electronic advertising application documents should be consistent with the application materials.
I often do this kind of approval and filing work!