Retain product registration

Fulfil registration condition

You can view your product's registration conditions and post-approval commitments at Enquire@PRISM.

To notify HSA and submit documents to fulfil a registration condition, please use the online form at https://go.gov.sg/fulfil-tp-reg-conditions.

Retention fee due date

The retention fee due date for each therapeutic product falls on every anniversary of the date of registration of the therapeutic product. 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. Please note that the GIRO collection process would usually be completed about 1 – 2 weeks after the retention fee due date of the product registration.

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 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.

Companies with a GIRO account with HSA can also choose to log in to Renew@PRISM to initiate the retention process (“manual retention”) 60 days in advance of the auto-retention process.

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

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 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 (apply eGIRO).

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 (COR) 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.
• HSA Client Code of the new registrant.
• 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.

Change of Registrant (COR) application process

There are two parts to a COR application: 

A. The initiation of the transfer by the existing product registrant; and
B. The acceptance of the transfer by the new product registrant.

Part (A) - The initiation of the transfer by the existing product registrant

The existing registrant has to initiate the transfer of the affected therapeutic product registration via Transfer@PRISM.

Upon successful submission of the COR application by the existing registrant, a transaction number will be generated by the system. An email notice will also be sent to the new registrant.

Note: Each COR 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.

Part (B) - The acceptance of the transfer by the new product registrant

Upon receipt of the email notice, the new registrant is required to complete the COR application online via Transfer@PRISM within 30 calendar days.

Upon successful submission of the COR application by the new registrant, an application number will be generated by the system.

Turnaround time

The turnaround time is 14 working days from the date of receipt of the complete submission of the COR application by the new registrant.

Upon successful transfer of the product registration, the new registrant will be able to view the latest product registration information via Enquire@PRISM.

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