Registration overview of therapeutic products

  1. Retain, cancel or transfer therapeutic product registrations

Retain, cancel or transfer therapeutic product registrations

Find out how to retain, cancel or transfer your registered therapeutic products from the Register of Therapeutic Products.

Retain product registration

Retain product registration

All registered therapeutic products are entered into the Register of Therapeutic Products, which is a searchable database on our website. You need to pay an annual retention fee to retain your registered therapeutic product on the register.

Registered products will remain in the register, unless the following happens:

  • The registration is suspended or cancelled by us.
  • The registration is cancelled by the registrant.
  • No payment is made for the annual retention fee within 60 calendar days after the retention fee due date.

The annual retention process for therapeutic products is an automatic process if your company has an existing GIRO account with us. The retention applications will be automatically created in the system one day after the product retention due date, and the GIRO collection process will usually be completed about one to two weeks thereafter.

If your company does not have an existing GIRO account with us, you will have to initiate the retention process manually.

If you do not intend to retain your product on the register, please refer to details on cancelling a product registration.

Retention fee due date

The due date for first annual retention fee of a product is one year after the product's registration date. When the annual retention fee payment is successfully made, the retention fee due date will be updated to one year from the current retention fee due date.

A retention notice will be sent to the product registrant 60, 30 and 15 calendar days before the retention fee payment is due. If payment is not received, reminder notices will be sent 1, 15 and 30 calendar days after the fee payment due date as well.

When the annual retention fee payment is successfully made, the retention fee due date will be updated to one year from the current retention fee due date.

The product registrations remain active within 60 days from retention fees due date and the registration status can be verified online via the Register of Therapeutic Products.

You are advised to update your particulars at amend@prism to ensure that retention notifications are received.

Retention fee payment

The retention fee would be charged to the current product registrant on the retention fee due date, regardless of any pending change of registrant applications.

Note:
  1. If payment is made after a reminder notice is sent 30 calendar days after the fee payment due date, the late fee payment must be accompanied by reasons for late payment.
  2. Notification for retention fee payment will not be sent for any pharmaceutical drugs that are suspended by us. Payment of retention fee will resume only after registration is unsuspended.

GIRO payments

You are encouraged to make payment for the retention fee via GIRO (application form227 KB). To activate GIRO payment, please fill up the application form and mail the original copy to:

Health Sciences Authority 11 Outram Road
Singapore 169078


Upon successful GIRO deduction, an e-mail will be sent to you informing of the completion of the retention procedure.

Non-GIRO payment

Log on to renew@prism to make payment via eNETS or credit card if:

  • You don't have a GIRO account.
  • It is 30 calendar days after the fee payment due date for GIRO account holders.

Refer to our guide for Retention of Therapeutic Product on the Product Register266 KB for more information.

Cancel product registration

Cancel product registration

You may cancel your pharmaceutical drug registration via cancel@prism at any time. However, there will be no refund of the retention fee if you choose to cancel after the fee is triggered.

Once a product registration is cancelled, you will need to submit a new application for the product to be registered again. We are unable to accommodate any requests for reinstatements once the product registration has been cancelled.

Turnaround time

The turnaround time for the approval of the cancellation application is seven working days upon submission of the application.

Supply of pharmaceutical drugs after registration cancellation

A supplier may continue to supply the pharmaceutical drug by retail sale after its registration is cancelled, before its product expiry date, if:

  • Your registration is cancelled due to a failure to pay the retention fee within the prescribed time.
  • Your application for cancellation of your pharmaceutical drug registration is approved by us.
  • You took possession of the pharmaceutical drug before the registration cancellation.
  • We do not direct a recall of the pharmaceutical drug from the market.

Transfer product registration

Transfer product registration

The transfer of product registration refers to the change of registrant for registered pharmaceutical drugs from one company to another company.

New registrant eligibility

The new registrant must be a business entity currently registered in Singapore with the Accounting and Corporate Regulatory Authority (ACRA) and has an active CRIS account with us.

Before submission of transfer application

The existing registrant should, prior to submission of the transfer application, conclude any pending:

  • Variation application for the pharmaceutical drug to which the transfer relates.
  • Payment of annual retention fee.

Note: We are unable to process any transfer application if there are any variation applications pending for your product.

Information and documents required

The following documents must be submitted by both the existing and new registrants via transfer@prism.

From the existing registrant:

  • Unique Entity Number (UEN) of the new registrant to which the product registrant is to be transferred.
  • Email address of the authorised person acting on behalf of the new registrant.
  • Registration number and name of the pharmaceutical drugs for which the registration will be transferred to the new registrant.

From the new registrant:

  1. Letter of Authorisation from the new product owner must be submitted to include:
    • The product owner's company letterhead, the full name of the pharmaceutical drug and its Singapore product registration number, as well as the name and address of the new registrant.
    • A statement authorising the new registrant.
    • A statement to withdraw the authorisation granted previously to the existing registrant.
    • The proposed effective date for the transfer.
  2. Written confirmation that arrangement has been made with the existing registrant for the handing over of the relevant product registration files.

Transfer application process

The transfer application process is as follows:

    1. The existing registrant initiates the application via transfer@prism.
    2. The new registrant will receive an e-mail notice with the PRISM transaction number after the existing registrant has applied to initiate the transfer of the product registration.
    3. The new registrant will then have to retrieve the draft application via transfer@prism;using the transaction number, and submit the completed application in PRISM within 30 calendar days of receiving the e-mail notice.

    Note: Each PRISM application allows a maximum transfer of 20 product registrations. You will need to submit multiple application forms in PRISM if you have more than 20 products to be transferred at any one time.

    Turnaround time

    The turnaround time is 14 working days upon complete submission of the application by the new registrant.

    Refer to our Guidance for Change of Registrant for Registered Therapeutic Product178 KB for more information.

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