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Registration overview of Class 2 CTGTP

  1. Retain, cancel or transfer CTGTP registrations

Retain, cancel or transfer CTGTP registrations

Find out how to retain, cancel or transfer your registered CTGTP from the Register of Cell, Tissue or Gene Therapy Products.

Retain product registration

Retain product registration

All registered CTGTP are entered into the Register of Cell, Tissue or Gene Therapy Products, which is a searchable database on our website. You need to pay an annual retention fee to retain your 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 CTGTP is an automatic process if your company have an existing GIRO account with us. The retention applications will be 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, an invoice and the payment instructions will be sent via email to you. 

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.

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 Cell, Tissue or Gene Therapy Products.

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 products that are suspended by us. Payment of retention fee will resume only after registration is unsuspended.

GIRO payments

You are encouraged to make payment via GIRO. To activate GIRO payment, please fill up the Inter-bank GIRO Application Form227 KB 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.

 

Cancel product registration

Cancel product registration

You may cancel your CTGTP registration by emailing us on your request at any time. However, there will be no refund of the retention fee if you choose to cancel after the fee is triggered and collected.

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 CTGTP after registration cancellation

A supplier cannot continue to supply the CTGTP after its registration is cancelled.

Transfer product registration

Transfer product registration

The transfer of product registration refers to the change of registrant for registered CTGTP 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 current registrant should conclude any pending:

  • Variation application for the CTGTP 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 current and new registrants via email to HSA_CTT_Enquiry@hsa.gov.sg.

From the current registrant:

  1. Unique Entity Number (UEN) of the new registrant to which the product registration is to be transferred.
  2. Email address of the authorised person acting on behalf of the new registrant.
  3. Registration number and name of the CTGTP 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 CTGTP 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 current registrant.
    • The proposed effective date for the transfer.
  2. Written confirmation that arrangement has been made with the current registrant for the handing over of the relevant product registration files.

Transfer application process

The transfer application process is as follows:

    1. The current registrant initiates the application via email to HSA_CTT_Enquiry@hsa.gov.sg.
    2. The new registrant will receive an e-mail notice with a transfer application form and registrant transfer fees payment instructions from HSA after the current registrant has applied to initiate the transfer of the product registration.
    3. The new registrant will then have to submit the completed registrant transfer application form by replying to the email notice within 30 calendar days and make the payment for the registrant transfer fees.

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

    Fees and turn-around-time

    Refer to CTGTP fees and turn-around-time for more information.

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