Processed by: Medicine Registration Division of Shanghai Municipal
Medicine Administration
Formalities: When applying for packaging of imported
drug in China, the applicant shall also submit the following materials in
addition to the applications of the Chinese side and foreign side.
(1) A
photocopy of Import Medicine License (Original) issued by the State Medicine
Administration;
(2) The copy of contract or agreement signed between the
Chinese side and foreign side;
(3) A photocopy of Permit for Medicine
Manufacturing Enterprise and Good Manufacture Practice for Medicine held by
enterprise engaged in drug (divided) packaging;
(4) Overview materials
(prescription, pharmacological, toxicological, and clinical research materials)
in Chinese;
(5) Quality standard (Both in Chinese and English);
(6)
Instructions (Both in Chinese and English);
(7) Design samples for package
and label;
(8) Flow chart for package technology.
(9) After (divided)
packaging, Chinese must be used in the package, label and instructions of the
medicine which may also be accompanied by translations in foreign language and
be processed according to the relevant requirement of the Administrative Rules
for Medicine Package, Label and Instructions (Provisional). The marked
manufacturer is the enterprise on foreign side that supplies medicine; The
package plant is a domestic enterprise.
Procedures: (1) Making application
and submitting the relevant information / (2) being accepted / (3) undergoing
initial examination / (4) being reported to the upper authorities
Charge rate
and basis: Referencing to the charge rate for applying for the production of
four types of new drugs: RMB 3500 for each type
Submitted to: Shanghai
Municipal Drug Administration
Processed at: Rm. 1101, 11/F, Shuguang
Building, 189 Puan Rd., Shanghai
Basis: Rules on Divided Packaging of
Imported Drug in China Promulgated by the Ministry of Public Health on November
17, 1992 and its revised draft.
Tel.: 63855666
Website:
Office hours:
9:00 a.m. - 11:00 a.m. 2:00 p.m. - 5:00 p.m. Tuesday and Thursday
Period:
Acceptance: 5 days for examination and verification: Not exceeding 30 days
(calendar day)
Qualification of the applicant: |
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