You need to submit the following documents:
- Site Master File.
- This is a mandatory requirement and the scanned copy of the document can be submitted as an attachment to the application.
- The Site Master File should be prepared in accordance with the PIC/S Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File.
- Certificate of Accreditation of the contract testing laboratory, if any.
- Letter of approval issued by the agency or institution that approves the use of the premises for
the manufacturing and storage of health products, if applicable.
- Details of the dosage forms and products manufactured and assembled.
- Indicate if your company is acting as a contractor acceptor (i.e. manufactures partially or wholly for others) for these products.
Fees and turnaround time
Refer to Chinese Proprietary Medicine fees and turnaround time
for more information.
Good Manufacturing Practice audits
Compliance to Good Manufacturing Practice (GMP) standard is mandatory for all therapeutic products manufacturers, including assemblers.
When your licence application is received, we will contact your company to arrange for a pre-approval audit. A pre-audit letter will be sent to inform you of the date of GMP audit.
Your Site Master File (SMF) should be prepared in accordance with the Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) available from the PIC/S Publication website. The following topics need to be addressed in your SMF:
- General Information
- Pharmaceutical Quality System
- Premises & Equipment
- Quality Control
- Outsourced Activities
- Complaints and Product Recall
A manufacturer’s licence would only be issued 10 working days from date of audit close out, if your company has been found to have complied with the required GMP standards.
After licence approval, regular routine audits will be conducted to assess your company’s continued compliance. The frequency of the routine audit would depend on risk factors like the activities conducted by your company and your compliance level with the regulatory requirements. Unannounced audits may also be conducted.
How to apply
Submit your application through PRISM. Ensure you have the following before you access the e-service:
If you encounter technical issues, e-mail the HSA helpdesk or call 6776 0168 (from 7.00 am to midnight daily).