Application for License for Business Start of Preparation Room of Medical Instit

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

Processing Authority: Safety Control Office under Shanghai Food and Drug Administration

Processing Procedures:

1. Application for Business Start

1) Any and all of applicants for business start of the proposed preparation rooms of the medical institutions shall represent any and all of the following materials to Shanghai Food and Drug Administration:

a. the report of application for business start of the preparation room of the medical institution;

b. the (xerox copy of the) license for practice of medical institution;

c. the relevant document of approving business start of the preparation room of the medical institution by the public health administration at the municipal level;

d. the personal resume of each technical personnel majoring in pharmacy of the proposed preparation room (including name, age, sex, higher education, working time of the previous carrier, proposed work position, etc.);

e. the main quality management system of the proposed preparation room;

f. the catalogue of the main apparatus and equipments equipped to the proposed preparation room; and

g. the technique plan layout and the over ground plan of the proposed preparation room.

2) Shanghai Food and Drug Administration shall, within 15 working days upon receipt of the complete materials necessary for such application, complete the due review of them and make the decision of approving business start of the very applicant or not.

2. Application for License of Preparation of Medical Institution

1) Any and all of applicants shall, upon holding the notice of approving business start of preparation room of medical institution issued by Shanghai Food and Drug Administration and completion of construction of the proposed preparation room subject to the Good Preparation Practice of Medical Institutions (GPP), apply to Shanghai Food and Drug Administration for inspection and issue of the License of Preparation of Medical Institution, and present any and all of materials as follows:

a. the xerox copy of the notice of approving business start of preparation room of medical institution issued by Shanghai Food and Drug Administration;

b. the report of application for inspection and issue of the License of Preparation of Medical Institution;

c. the self-check report subject to the Standard for Inspection of Preparation Room of Medical Institution; and

d. the application form of the License of Preparation of Medical Institution in duplicate.

2) Shanghai Food and Drug Administration shall, within 20 working days upon receipt of the complete materials necessary for such application, complete the due review of them and make the decision of issuing the License or not.

Charging Standard & Basis: RMB 150 per License of Preparation of Medical Institution (for Class I Medical Institution); and

RMB 300 per License of Preparation of Medical Institution (for Class II/III Medical Institution)

Processing Address: Room 1201, No. 189, Pu'an 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 promulgated on February 28th, 2001;;

2. Good Preparation Practice of Medical Institutions (GPP);

3. Standard for Inspection of License of Preparation of Medical Institution (attachment of Guo Tao Guan An [2000] No. 275); and

4. Letter on Adjustment of Charging Scale for License of Drug Production(/Operation) Medical Institution (Hu Jia Xing [2000] No. 153 and Hu Cai Zong [2000] No. 045)

Contact Tel: 021-63855666

Processing Time: Mondays through Fridays: 9:00~12:00

Time Limit for Processing: In case of application for business start: within 2 working days for confirmation of acceptance, and within 15 working days for review and approval; and

In case of application for license: within 2 working days for confirmation of acceptance, and within 20 working days for review and approval.

Qualified Application Subject: Any and all of applicants:

1. that have technical personnel majoring in pharmacy with certified qualifications;

2. that have the system ensuring the implementation and management of quality of preparation, test apparatus, and sanitation conditions; and

3. that hold the relevant documents of approving business start of preparation room of medical institutions issued by Shanghai Food and Drug Administration.

Source: 上海市人民政府

Keywords:Quality Supervision

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