Processing Authority: Drug Registration Office under Shanghai Food and
Drug Administration (at No. 189, Pu'an Road, Shanghai, 200021, Tel: 63855666
ext)
Processing Procedures: Any application for drug processing export shall
be accepted and form-reviewed by Registration Acceptance Window of Shanghai Food
and Drug Administration. In case of meeting requirements in form review, such
application shall be forwarded to Shanghai Drug Review Center which shall,
within 10 working days in case of technical review, complete the due review and,
in case of full materials meeting requirements, report to Shanghai Food and Drug
Administration which shall, within 10 working days in case of meeting
requirements upon due review whereby, issue the Document of Shanghai Food and
Drug Administration Approving Drug Processing Export and report to State Food
and Drug Administration for record filing, or in case of not meeting
requirements, reject the application. In case the enterprise is concurrently
applying for the Certificate of Drug Export, the very applicant can, by
presenting the notice of acceptance, send samples (of 3 batches) to Shanghai
Institute of Drug Control for inspection. Shanghai Drug Review Center will,
within 7 working days upon receipt of the report of passing inspection by
Shanghai Institute of Drug Control, the opinion of review, and the Document of
Shanghai Food and Drug Administration Approving Drug Processing Export, complete
due formalities and report to Shanghai Food and Drug Administration which shall,
within 5 working days in case of meeting requirements upon due review whereby,
bring out the opinion of approval.
Attachments:
Materials necessary for
application for drug processing export:
(I) the (notarized) supporting
document for business registration of the overseas drug manufacturer in the
county where it is located;
(II) the xerox copy of agreement or contract for
processing export on commission;
(III) the xerox copy of the registration
book of trade of processing with customer's materials approved by the state
foreign trade and economic cooperation authority in case of processing with
customer's materials, if any;
(IV) the xerox copy of the License of Drug
Production or the certificate of drug GMP of the very domestic drug production
enterprise which is entrusted;
(V) the formula, production technique and
quality standard of the very drug, and the Chinese translation whereof;
(VI)
the pattern of proposed package, label, and instruction used for
export;
(VII) the quantity of the proposed bulk drug or loose package
preparation for use, and the manufacturer's name and address whereof;
(VIII)
the very domestic drug production enterprise which is entrusted shall, within 60
days upon export and off-shore of the very drug, report to Registration
Acceptance Window of Shanghai Food and Drug Administration to state export of
the very drug which is approved to be processed and exported by attaching the
xerox copies of invoice, shipping document and other relevant documents;
and
(IX) the Application Form for Drug Processing Export in Shanghai (in
triplicate).
Processing Address: Room 1106, F/11, No. 189, Pu'an Road,
Shanghai
Processing Basis: Notice on Printing and Forwarding Regulations on
Administration of Drug Processing Export (for Trial Implementation) (Guo Shi Yao
Jian Zhu [2003] No 189)
Contact Tel: 63855666 ext.
Processing Time:
Tuesdays or Thursdays: 9:00~11:30 and 14:00~17:00
Time Limit for Processing:
Registration Acceptance Window of Shanghai Food and Drug Administration: within
2 working days; Shanghai Drug Review Center: within 10 working days; and
Shanghai Food and Drug Administration: within 10 working days; and
In case of
application for the Certificate of Drug Export, Shanghai Drug Review Center:
within 7 working days upon receipt of the report of passing inspection by
Shanghai Institute of Drug Control; and Shanghai Food and Drug Administration:
within 5 working days.
Qualified Application Subject:
Any application for
processing export by any drug production enterprise in Shanghai that is
entrusted by the overseas drug manufacturer to use the overseas or domestic bulk
drugs, auxiliary materials, loose package preparation or packaging materials,
comply with the formula, production technique, quality standard or packaging
label provided whereby, and produce or pack and export drugs to the country or
region designated whereby.
Any drug production enterprise in Shanghai that is
holding the License of Drug Production. |
|
