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Processing Procedures: The fundamental procedures for drug import record
filing can be divided into four phases as inspection of materials for record
filing, check of supporting documents for registration, acceptance, and
processing.
(I) Inspection of Materials for Record Filing
Any and all of
applicants shall, subject to Article XIII under the Measures for Administration
of Drug Import, fill in the Application Form for Inspection of Imported Drug,
and present any and all of materials necessary for import record filing (see
attachments for details) in duplicate by holding the original of the Certificate
of Registration of Imported Drug (or the Certificate of Registration of Medical
Product (original or copy)), and the original of the Certificate of Import
Permit for narcotics/psychotropic drugs, in case of importation whereof, to
Import Record Filing Acceptance Window of Drug Registration Office under
Shanghai Food and Drug Administration which will, upon receipt of the
Application Form for Inspection of Imported Drug in both paper and electric
forms and other relevant materials, check the completeness and trueness of those
materials one by one. The Application Form for Inspection of Imported Drug can
be downloaded from
www.sfda.gov.cn
or
www.nicpbp.org.cn
.
(II) Check of
Supporting Documents for Registration
The inspector of Import Record Filing
Acceptance Window shall inspect the trueness of the original of the Certificate
of Registration of Imported Drug (or the Certificate of Registration of Medical
Product (original or copy), or Certificate of Import Permit, or Document of
Approval for Imported Drug) at site.
(III) Acceptance
In case the
materials necessary for record filing are complete and true, and the original of
the Certificate of Registration of Imported Drug (or the Certificate of
Registration of Medical Product (original or copy), or Certificate of Import
Permit, or Document of Approval for Imported Drug) passes inspection at site,
such application can be accepted, and the above originals can be returned to the
very applicant.
(IV) Processing
1. With regard to drugs sold within the
Chinese territory for the first time under Article X of the Measures for
Administration of Drug Import and other drugs specified by State Council (see
Note 4 for details), the inspector of Import Record Filing Acceptance Window
shall, within the same day upon completing due review of full materials, issue
the Notice of Sampling of Imported Drug with a full set of materials for
application to Shanghai Institute of Drug Control, and issue the Notice of Port
Inspection of Imported Drug to Shanghai Customs, or, in case of not meeting
requirements, issue the Notice of Rejecting Drug Import Record Filing at the
same day upon application.
After Shanghai Institute of Drug Control completes
inspection, the inspector of Import Record Filing Acceptance Window shall,
within the same day upon receipt of the Report of Inspection of Imported Drug,
issue the Form of Customs Clearance for Imported Drug to those varieties with
the inspection comment of "Compliance with Requirements of Standard", or the
Notice of Rejecting Drug Import Record Filing to those varieties with the
inspection comment of "Not Compliance with Requirements of Standard",
With
regard to biological products specified in Article X of the Measures for
Administration of Drug Import and by State Food and Drug Administration, the
inspector of Import Record Filing Acceptance Window shall, within the same day
upon completing due review of full materials, issue the Form of Customs
Clearance for Imported Drug to Shanghai Customs, and issue the Notice of Port
Inspection of Imported Drug with a full set of materials for application to
Shanghai Institute of Drug Control, or, in case of not meeting requirements,
issue the Notice of Rejecting Drug Import Record Filing at the same day upon
application. Those unqualified drugs shall, upon sampling by Shanghai Institute
of Drug Control, be sealed until the very applicant has obtains the Report of
Inspection of Imported Drug indicating pass of inspection.
2. With regard to
drugs not specified in Article X of the Measures for Administration of Drug
Import and drugs with the Document of Approval for Imported Drug, the inspector
of Import Record Filing Acceptance Window shall, within the same day upon
completing due review of full materials, issue the Form of Customs Clearance for
Imported Drug to Shanghai Customs, and issue the Notice of Port Inspection of
Imported Drug with a full set of materials for application to Shanghai Institute
of Drug Control, or, in case of not meeting requirements, issue the Notice of
Rejecting Drug Import Record Filing at the same day upon application.
3. With
regard to narcotics and psychotropic drugs, the inspector of Import Record
Filing Acceptance Window shall, within the same day upon completing due review
of full materials, issue the issue the Notice of Port Inspection of Imported
Drug with a full set of materials for application to Shanghai Institute of Drug
Control without necessity of issuing the Form of Customs Clearance for Imported
Drug, or, in case of not meeting requirements, shall not issue the Notice of
Port Inspection of Imported Drug.
Notes:
1. The import record filing
referred herein means the process where the importing unit applies to the
competent food and drug administration which governs the place where the port
allowing drug import is located (hereinafter referred to as the port food and
drug administration) for the Form of Customs Clearance of Imported Drug. The
import record filing for narcotics and psychotropic drugs means the process
where the importing unit applies to the competent port food and drug
administration for the Notice of Port Inspection of Imported Drug.
2. The
drug import ports affiliated to Shanghai Customs are Hongqiao Airport, Pudong
Airport, Office of Shanghai Post Office, Wusong Port.
3. Cases free from
import record filing: drugs from offshore into the bonded warehouse, bonded zone
or export processing zone; bulk drugs and crude drugs imported in the form of
processing trade upon due approval; and a small amount of drugs carried about by
persons entering/leaving China for personal use.
4. Drugs fall into the
category provided by Article X of the Measures for Administration of Drug
Import:
(1) biological products specified by State Food and Drug
Administration;
(2) drugs sold within the Chinese territory for the first
time; and
(3) other drugs specified by State Council.
Attachments:
I.
Materials necessary for Application for Import Record Filing:
1. the original
and xerox copy of the Certificate of Registration of Imported Drug (or the
Certificate of Registration of Medical Product (original or copy)), the original
and xerox copy of the Certificate of Import Permit for narcotics and
psychotropic drugs, and/or the original and xerox copy of the Document of
Approval for Imported Drug, all of which will be returned upon review at
site;
2. the xerox copies of both License of Drug Operation and Business
License of Incorporated Enterprise of the very applicant, and the License of
Drug Production in case the drug production enterprise independently import bulk
drugs and preparation intermediates necessary for production whereof. if
any;
3. the xerox copy of the certificate of origin;
4. the xerox copy of
the purchase contract;
5. the xerox copies of the packing list, bill of
lading, and freight invoice;
6. the xerox copy of report of ex works
inspection;
7. the patterns of the instruction, packaging, and label of the
very drug (excluding the bulk drugs and preparation intermediates);
8. the
original of the production inspection record brief and the supporting document
for approval issued by the drug administration authority of the country or
region of production in case of the biological products approved and issued by
State Food and Drug Administration; and
9. the xerox copies of the latest
Report of Inspection of Imported Drug and Form of Customs Clearance of Imported
Drug in case of drugs not specified in Article X under Measures for
Administration of Drug Import.
Any and all of the above materials and the
Form of Application for Inspection of Imported Drug as well as the electric
version whereof shall be presented in duplicate.
Processing Address: Import
Record Filing Acceptance Window of Shanghai Food and Drug Administration: within
Shanghai Institute of Drug Control
Address: No. 615, Liuzhou Road, Shanghai,
200233
Tel: 64828780 Fax: 64704543
Import Record Filing Acceptance Window of Shanghai Food and Drug
Administration: Waigaoqiao Free Trade Zone
Address: Shanghai Waigaoqiao
Medicine Distribution Center, No. 439, Futexi Yi Road, Waigaoqiao Free Trade
Zone, Shanghai
Tel & Fax: 58682519
Processing Time: Mondays through
Fridays: 8:30~16:00
Make an appointment in phone for any of non-processing
time to Shi Xiaoye at 13681781566
Processing Basis: Measures for
Administration of Drug Import under Joint No. 4 Order of State Food and Drug
Administration and General Administration of Customs of the People's Republic of
China
The above document can be downloaded from
http://www.sda.gov.cn
Qualified Application
Subject:
Any application for import record filing for goods CIF Shanghai
(see Note 2 for details), including any and all of drugs leaving the bonded
warehouse, warehouse of exports under supervision, bonded area, or export
processing zone into the China's domestic market (see Note 3 for
details).
The very applicant shall be the independent corporate holding the
License of Drug Operation.
The drug production enterprise which imports the
bulk drugs and preparation intermediate necessary for production whereof
(including preparation for sub-packaging within the Chinese territory) shall
hold the License of Drug Production.
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