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¡ª62837766
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). |
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