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Application for Continuing Production upon Expiration of Valid Term of Supportin
[2008-12-23 16:54:10]
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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. |
Source: 上海市人民政府
Keywords:Quality Supervision
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