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Licensing and Certification of Manufacturers

  1. Apply for an active ingredient manufacturer's licence

Apply for an active ingredient manufacturer's licence

Find out the requirements and how to apply for an active ingredient manufacturer's licence.

New application

Preparing for application

To apply for a licence, you will need to prepare the following information:

  • the applicant’s details

  • the manufacturing site details, including
    • manufacturing site address
    • contact name and contact details
    • name and resume of the responsible person in charge of quality operation
    • name and resume of the responsible person in charge of production
    • details of the manufacturing activities
    • details of any outsourced testing and storage activities

Compliance with the manufacturing and regulatory requirements

Prior to submitting the application, you should ensure that you comply with the principles and guidelines specified in the Pharmaceutical Inspection Convention and Pharmaceutical Inspection Co-operation Scheme (PIC/S) Guide to Good Manufacturing Practice for Medicinal Products, including appointment of suitable responsible persons for production and quality operations.

HSA would normally assess the manufacturer’s compliance through an on-site inspection.

For new licence application, the assigned inspectors would contact you to arrange for pre-approval inspection within 3 months from the date of application. Following the inspection, you may take some time to provide a satisfactory response to any inspection findings, which could vary from 3 to 12 months.

Once the inspection is satisfactorily closed out, the licence application will be approved in 10 working days from the date of inspection close-out. The manufacturer’s licence is issued electronically in PRISM after approval of the application.

You are advised to consider the timeline involved in the licence application process in your planning and ensure that you are inspection-ready before submitting the application.

If you are considering establishing a new manufacturing site in Singapore, you are encouraged to engage with the HSA at an early stage to facilitate the licence application process. You can reach out to Good Manufacturing Practice Unit via hsa_gmp@hsa.gov.sg

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).

Fees and turnaround time

 Refer to active ingredient licence and certificate fees and turnaround time for more information.

Withdrawal of Application

At any point of time, if you do not wish to proceed further with the new application, you could withdraw the application via PRISM.

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