Processing Authority: Drug Registration Office under Shanghai Food and
Drug Administration
Processing Procedures:
1. Any and all of drug
production enterprises applying for re-registration shall, 6 months prior to
expiration of the valid term of drug, apply to Shanghai Food and Drug
Administration for re-registration, fill in the Application Form for
Re-registration of Drug, and present any and all of materials necessary for such
application (printed out in A4-size paper and made in duplicate).
2. Shanghai
Food and Drug Administration shall, upon due review of those materials for
application, present those qualified application to State Food and Drug
Administration for record filing, and, in case of no notice of rejection of
re-registration by State Food and Drug Administration within 50 days, grant such
application for re-registration, or present the result of rejection of
re-registration of those not qualified to State Food and Drug Administration
which will issue the notice of rejection of re-registration and cancel the
registered number of approval for the very drug.
Charging Standard &
Basis: RMB 50 per variety as the registration charge
Processing Address: Room
1106, No. 189, Pu'an Road, Shanghai
Processing Basis: Pharmaceutical
Administration Law of the People's Republic of China under No. 14 Presidential
Order of the People's Republic of China;
Regulations of Implementation of
Pharmaceutical Administration Law of the People's Republic of China under No.
360 Order of State Council of the People's Republic of China;
Measures for
Administration of Registration of Drug (for trial implementation) under No. 35
Order of State Food and Drug Administration; and
Notice on Adjustment of
Charging Scale for drug Review and Inspection under Ji Jia Ge [1995] No. 340
jointly issued by State Plan Commission and Ministry of Finance.
Contact Tel:
63855666-142
Processing Time: Tuesdays or Thursdays: 9:00~11:00 and
14:00~17:00
Time Limit for Processing: Shanghai Food and Drug Administration
shall, within 50 working days upon receipt of materials necessary for
application for re-registration of drug, complete review of such
application.
Qualified Application Subject: Any and all of drug production
enterprises that have obtained the registered number of approval for drug issued
by State Food and Drug Administration which is falling due and need to continue
production shall make application 6 months prior to expiration. |
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