Responsible Department: Shanghai Municipal Pharmaceutical Supervision and Administration Bureau Department of Pharmaceutical Safety Supervision

Procedure:
Handling Procedure: 1. Submitting the application
1）Medical institutions that wants to set up preparation laboratories shall submit the following documents to Shanghai Municipal Pharmaceutical Supervision and Administration Bureau:
a. Letter of application to set up preparation laboratory.
b. Business permit of the medical institution (copy).
c. Approval from municipal-level public health and administrative departments on setting up the preparation laboratory.
d. Resume (indicating name, age, sex, education, experience and job title) of major medical staff of the preparation laboratory.
e. Major quality assurance systems of the preparation laboratory.
f. Catalogue of major instrument and equipments of the preparation laboratory to be set up.
g. Production layout and overall floor layout of the preparation laboratory to be set up.
2）Shanghai Municipal Pharmaceutical Supervision and Administration Bureau will make its decision within fifteen days after the receipt of the application
2. Application for the Permit
1）After the application is approved by Shanghai Municipal Pharmaceutical Supervision and Administration Bureau, the applicant shall establish the preparation laboratory according to GPP（quality control regulation and then apply for the "Permit of Medical Institutions to Set up Preparation Laboratory" at Shanghai Municipal Pharmaceutical Supervision and Administration Bureau". The following documents shall be submitted:

a. Approval letter from Shanghai Municipal Pharmaceutical Supervision and Administration Bureau on permitting the establishment of the preparation laboratory (copy).
b. Letter of Application for the "Permit of Medical Institutions to Set up Preparation Laboratory".
c. A self-checking report in accordance with "Checking and Acceptance Standards of Preparation Laboratory of Medical Institutions".
d. Two copies of application form for "Permit of Medical Institutions to Set up Preparation Laboratory"
2）Shanghai Municipal Pharmaceutical Supervision and Administration Bureau will make its decision within twenty days after the receipt of the application.
Fee and Collection Standards: "Permit on Medicinal Institution Preparation Production" (A level medical institution) RMB 150 yuan for each permit; "Permit of Medical Institution Preparation Production" (B and C Level medical institutions) RMB 300 for each permit
Submitted to:
Address: Shanghai Pu'an Road No. 189 Room 1201

audituser：
According to: 1. "Law of the People's Republic of China on Pharmaceutical Administration"（Decree No.45 of the President of the People's Republic of China）

2. "Regulations on the Administration of Preparation Quality in Medical Institution"（GPP）；

3. Acceptance standards stipulated in "Permit of Preparation in Medical Institutions" (G.Y.G.A (2000) No. 275 Appendix)

4. "Letter on Adjusting the Charging Standards of Production (Selling) of Medicines in Medical Institutions" (H.J.H (2000) No. 153), (H.C.Z (2000) No. 045)

Telephone: 021-63855666

Web-site:
Working Hours: Monday to Friday 9:00-12:00 a.m.

Duration of Handling: Application for the Establishment: two working days.
Checking and approving: fifteen working days.
Permit application: two working days
Checking and approving: fifteen working days

Qualification of Applicants: 1. Medical institutions with relevant qualification.
2. Can ensure the quality of preparation, have effective management, testing equipment and hygiene quality.
3. Relevant documents from municipal-level public health and administrative departments on approving the establishment of preparation laboratory in medical institutions.