Application for Drug Advertisements in Shanghai Processing Authority: Circulatio

[2008-12-23 16:54:10]

Application Formalities:

1. the letter of application for the very drug advertisement;

2. the Review Form of Drug Advertisement in hexaplicate filled in by drug production enterprises or imported drugs agencies in Shanghai and stamped with the official seal whereof, if any, with the electrical-version of the advertisement (which shall be produced via using the advertisement review application software of State Food and Drug Administration which can be installed upon download from www.sda.gov.cn );

3. one original (which will be returned upon completion of review) and four xerox copies of the Review Form of Drug Advertisement presented by drug production enterprises or imported drugs agencies in other provinces, autonomous regions or municipalities in China upon due review and approval by the competent local food and drug administrations which govern the place where they are located;

4. the letter of authorization to launch the drug advertisement issued by the legal representative of the very drug production enterprise and stamped with the legal representative seal and official seal whereof;

5. the xerox copy of the personal identity card of the person who handles the very advertisement;

6. one xerox copy of the each copy of the License of Drug Production, License of Drug Operation, and Business License of Incorporated Enterprise;

7. one xerox copy of the each copy of the License of Advertisement Operation, and Business License of Incorporated Enterprise;

8. two xerox copies of the drug's registered number of approval, quality standard, and instruction stamped with the official seal whereof respectively;

9. two xerox copies of the registration certificate of the over-the-counter (OTC) drug in case of the advertisement of the OTC drug;

10. two xerox copies of the Registration Certificate for Imported Drug or Registration Certificate for Medical Product, the Port Inspection Report of Imported Drug, and the supporting documents of agencies for the very imported drug stamped with the official seal whereof respectively in case of application for launching advertisement for the imported drug;

11. the external packaging of the very drug;

12. the relevant supporting documents in case of any aspect of contents of the very drug advertisement involving the trade name, registered trademark, and/or patent of the drug, if any;

13. other supporting documents that can confirm the trueness of the contents of the very advertisement provided by laws and regulations; and

14. the TV storyboard, i.e. the frame, explanation of frame, aside, subtitles, andVHS, VCD or DVD, in case of TV advertisements, or script and home recording tape in case of radio advertisements, or sample works in case of plane advertisements, where the presented scripts shall be legible without any alteration, and shall be in conformity with the contents in VHS or recording tapes.

Processing Procedures:

(I) Any and all of drug production enterprises or imported drugs agencies in Shanghai intending to launch drug advertisements shall, prior to such launch, apply to Shanghai Food and Drug Administration and present any and all of required materials, and shall not launch until obtaining the registered number of approval wherefrom.

(II) Any and all of drug production enterprises or imported drugs agencies in other provinces, autonomous regions or municipalities in China intending to launch drug advertisements shall, prior to such launch, obtain the Registered Number of Approval from the competent local food and drug administrations which govern the place where they are located at first, and then apply to Shanghai Food and Drug Administration for record filing and present any and all of required materials, and shall not launch until completing any and all of formalities necessary for such record filing.

(III) Shanghai Food and Drug Administration shall, upon due review, issue the Registered Number of Approval for Drug Advertisement to the applicants in case of approval, or inform the applicants in writing with causes in case of not-approval.

Review of Advertisement:

(I) First Review

Shanghai Food and Drug Administration shall, within 10 working days upon receipt of the complete set of materials necessary for such application, conduct the due review of the content of the very drug advertisement and the relevant supporting documents, make the decision of the first review, and, in case of approval, issue the Notice of Decision of First Review of Drug Advertisement to the very applicant who shall produce the finished advertisement product subject to the approved contents in and requirements by the first review.

(II) Final Review

The very applicant shall, upon the Notice of Decision of First Review of Drug Advertisement, present the finished advertisement product to Shanghai Food and Drug Administration which shall, within 10 days upon receipt of complete set of materials necessary for such application, make the final decision, and, in case of approval, issue the Registered Number of Approval for Drug Advertisement to the very applicant, or, in case of not-approval, inform the very applicant with causes.

(III) Any and all of applicants are entitled to apply for the final review directly.

Processing Address: (Shanghai Certification Center of Qualification of Medical Industry) No. 1399, Huashan Road, Shanghai

Processing Basis: Advertisement Law of the People's Republic of China;

Pharmaceutical Administration Law of the People's Republic of China under No. 45 Presidential Order of the People's Republic of China promulgated on February 28th, 2001;

Regulations of Implementation of Pharmaceutical Administration Law of the People's Republic of China under No. 360 Order of State Council promulgated on August 4th, 2002; and

other applied administrative regulations on advertisement administration promulgated by the competent departments under State Council, and measures and standards of advertisement review formulated by the advertisement administration.

Contact Tel: 021―62837766

Processing Time: Mondays or Wednesdays: 9:00~11:00 and 13:00~16:00

Fridays: 9:00~11:30

Time Limit for Processing: The valid term of the registered number of approval for the drug advertisement shall be one year only. The valid term of the record of the drug advertisement from other part of China for launch in Shanghai shall be subject to the valid term whereof in the place where it is approved.

Qualified Application Subject: Any and all of drug production enterprises or imported drugs agencies in Shanghai applying for launching drug advertisements.

Any and all of drug production enterprises or imported drugs agencies in other provinces, autonomous regions or municipalities in China applying for launching drug advertisements in Shanghai (record filing).

Source: 上海市人民政府

Keywords:Quality Supervision

GACC Announcement No.56, 2014 on Cross-Border E-Commerce Trade Supervision (2014-08-05)
China Joint Announcement No.1851, 2014 on Precursor Chemicals “1-Phenyl-2-bromo-1-propanone” & “3-oxo-2-phenylbutyronitrile” Supervision (2014-06-24)
GACC Decree No.208 on Supervising Pingtan Experimental Area (2013-07-23)
Measuring Instrument Administration to be Strengthened (2009-12-17)
Chinese Insurance Regulator Stresses Supervision on Insurance Investment (2009-11-16)
Liu Mingkang: China and the US will Deepen Cooperation of Cross-border Supervisi (2009-08-04)
The National Standard for the General Rule for Enterprises Quality Credit Rating (2009-06-18)
Chinese Gov't Pledges Better Quality Supervision over Farm Products (2009-02-02)
Chinese Gov't Pledges Better Quality Supervision over Farm Products (2009-02-02)
[Imports Management ] General Administration of Quality Supervision, Inspection (2009-01-20)

Partners: China Customs | China Customs Statistics | China International E-Commerce | Customs-info