Application for Registration of Materials/Containers for Drug Packaging in Shang

[2008-12-23 16:54:10]

Processing Authority: Drug Registration Office under Shanghai Food and Drug Administration

Processing Procedures:

1. Any and all of applicants shall fill in the Application Form for Registration of Materials/Containers of Drug Packaging and present the required materials and specifications to Shanghai Food and Drug Administration which authorizes Shanghai Drug and Medical Appliances Review Center (hereinafter referred to as Review Center) to accept such application for registration by those applicants (note: the Application Form for Registration of Materials/Containers of Drug Packaging is available at Review Center);

2. The very applicant shall present the required materials to Review Center which will, upon meeting requirements for form review, issue the notice of acceptance of registration of materials/containers for drug packaging;

3. Review Center will, upon acceptance, arrange the field sampling, inform the test institution of quality of drug packaging material to conduct technical review of the quality of the very drug packaging material, and organize personnel to conduct inspection of the drug packaging material enterprise subject to the General Rules for Inspection of Registration of Materials/Containers for Drug Packaging.

4. The competent test institution of quality of drug packaging material will, upon receipt of the notice of inspection of registration, inspect the samples and present the report of inspection to Review Center in due course of time.

5. Review Center will, upon result of inspection and of the test institution of quality of drug packaging material, summarize the opinions of review and report to Shanghai Food and Drug Administration.

6. Shanghai Food and Drug Administration will review the opinions presented by Review Center, and, in case of meeting requirements, report to State Food and Drug Administration for final review and issue of the Certificate of Registration of Drug Packaging Material to the very applicant of Class I drug packaging material, or directly issue the Certificate of Registration of Drug Packaging Material to the very applicant of Class II drug packaging material.

Processing Address: No. 18399, Huashan Road, Shanghai

Processing Basis: 1. Pharmaceutical Administration Law of the People's Republic of China under No. 45 Presidential Order of the People's Republic of China;

2. Regulations of Implementation of Pharmaceutical Administration Law of the People's Republic of China under No. 360 Order of State Council; and

3. Measures for Administration of Materials/Containers for Drug Packaging (for interim implementation) under No. 21 Order of State Food and Drug Administration.

Contact Tel: 62949719

Processing Time: Tuesdays or Thursdays: 9:00~11:30 and 13:30~17:30

Time Limit for Processing:

1. Review Center shall, within 2 days upon receipt of the materials required for application, make the decision of acceptance or not;

2. Review Center shall, upon issue of the notice of acceptance, arrange within 5 days and organize within 15 days inspection, sampling, and inform the test institution of quality of drug packaging material to conduct test;

3. The competent test institution of quality of drug packaging material shall, within 30 working days upon receipt of the notice of inspection of registration, complete inspection of the samples, or within 60 working days in case of the review of quality standard, if necessary;

4. Review Center shall, within 7 days upon receipt of result from the test institution of quality of drug packaging material, summarize the opinions of review and report of inspection, and report them with materials for application presented by the very applicant to Shanghai Food and Drug Administration which shall, upon review and approval by the leader whereof, report to State Food and Drug Administration for final review and issue of the certificate of registration of drug packaging material, or directly issue the certificate of registration of drug packaging material

Qualified Application Subject: Products of drug packaging materials can be classified into Class I and Class II (see attached Annex 1 for classified catalogue of drug packaging materials).

Class I drug packaging materials refer to those materials/containers that make direct contact with drugs and are used directly.

Class II drug packaging materials refer to those materials/containers that make direct contact with drugs, but can be washed easily, and can be sterilized after washing up in the practical use.

1. Any and all of applicants shall hold the business licenses of incorporated enterprises.

2. Any and all of applicants shall possess the reasonable technique, equipments, requirements for cleanness, instruments for test and inspection, personnel, management system, and other necessary conditions assuring quality to produce the very product.

Source: 上海市人民政府

Keywords:Quality Supervision

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