Application for Certificate of Ephedrine Purchase and Use in Shanghai

Processing Authority: Drug Safety Supervising Department of Shanghai Drugs Administration Bureau

Processing Procedures:

I. Application

The drug manufacturers, medical treatment entities, and teaching and researching entities who apply for the employing of ephedrine should submit the following documents:

For initial application enterprises:

1. Drug manufacturers who use ephedrine:

a. Written application report for using ephedrine;

b. Drug registration number or clinical trial approval of prescriptions or compound preparations which include ephedrine (xerox copies);

c. Drug prescriptions (photocopy);

d. Managing mechanism of ephedrine (including system of purchasing, employing, and storage);

e. Promise letter of the legal entity using ephedrine;

f. Letter of introduction from the entity, ID card and photocopy of the person.

2. Using ephedrine for chemical production, medicine intermediate, pesticide, and resolving agent in research work

a. Validity testimonial for the entities that using ephedrine (xerox copies);

b. Testimonial for the necessity of using ephedrine in the production, related technical documents, and consuming ration of ephedrine as resolving agent;

c. The entity with municipal administrating authority need submit written application with approval of the authority. Entity without administrating authority need submit written application of the entity with juridical person status;

d. Managing mechanism of ephedrine (including system of purchasing, employing, and storage);

e. Promise letter of the legal entity using ephedrine;

f. Letter of introduction from the entity, ID card and photocopy of the person.

For non-initial application enterprises:

a. Written application report for using ephedrine;

b. Value-added tax invoice of purchasing ephedrine last time (xerox copies);

c. Letter of introduction from the entity, ID card and photocopy of the person.

II. Application accepting and approving

Drug Safety Supervising Department of Shanghai Drugs Administration Bureau will issue the Certificate of Ephedrine Purchase and Use to qualified non-initial applicant within 1working day after receiving complete application documents; For initial purchasing applicant, the time will be within 7 working days.

Processing Address: Room 1102, No. 189 Pu-An Road

Processing Basis:

Interim Administrating Regulations on Ephedrine (promulgated by Order No. 12 of State Drugs Administration Bureau

Notice of Further Strengthen the Administration on Ephedrine of State Council (Guo Fa [1998] No. 3)

Contact Tel: 021-63879380

Processing Time: Monday 9:00 a.m.―12:00 a.m. and 1:00 p.m.―5:00 p.m.

(Special circumstances will be dealt specially)

Time Limit for Processing: 7 working days for initial purchasing and employing application, and 1 working day for non-initial application

Qualified Application Subject:

The drug manufacturers, medical and researching entities within Shanghai administration scope, which use ephedrine.

Qualification of the applicants:

Drug manufacturers or medical entities with drug registration number or clinical trial approval of prescriptions or compound preparations which include ephedrine; teaching and researching entity which is approved to use ephedrine; pointing entity for the distribution of ephedrine.