- Site Master File (a scanned copy of the document can be submitted as an attachment to the application).
- Note: Site Master File should be prepared in accordance with the Explanatory Notes for Pharmaceutical Manufacturers on the Preparation of a Site Master File (SMF) available from PIC/S Publication website.
- 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 therapeutic products, if applicable.
- Details of the products and dosage forms manufactured and/or assembled, including the name and strength, as well as product registration number, if applicable. Also 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 therapeutic product fees and turnaround time for more information.
Good Manufacturing Practice audits
Compliance to Good Manufacturing Practice (GMP) standard is mandatory for all manufacturers of therapeutic products, 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 PIC/S Publication website. The following topics need to be addressed in your SMF:
- General information
- Pharmaceutical quality system
- Premises and equipment
- Quality control
- Outsourced activities
- Complaints and product recall
A manufacturer's licence will only be approved and issued 10 working days from the date of audit close out if your company is found to have complied with the required GMP standard.
After licence approval, regular routine audits will be conducted to assess your company's continued compliance. The frequency of the routine audits will depend on risk factors like the activities conducted by your company, and your level of compliance with the regulatory requirements. Unannounced audits may also be conducted.
An Audit Summary of a specific therapeutic products manufacturer may be requested with the manufacturer’s consent, by submitting this Application Form56 KB.
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).