Import and supply of unregistered Class 2 cell, tissue or gene therapy products (CTGTP)

Conditions for using this Special Access Route (SAR) 

The use of unregistered Class 2 CTGTP should only be considered for life-saving therapies, where there is an unmet medical need such as in situations where a registered treatment option is absent, and the patient's health will be clinically compromised without treatment with the unregistered CTGTP.

Note: The safety, quality and efficacy of these unregistered CTGTP are not assessed by us, hence requesting doctors are fully responsible for the use of such products on patients.

Eligibility

You can apply to import unregistered Class 2 CTGTP via this SAR if you are:

• A licensed hospital, clinic or nursing home importing the CTGTP for use by your own doctors or dentists on patients under their care.
• A licensed retail pharmacy acting on behalf of, and in accordance with a valid prescription issued by a registered doctor or dentist.
• A company acting on behalf of a licensed hospital, clinic or nursing home. You are required to obtain a wholesaler's licence from us prior to the import.

Your Class 2 CTGTP must fulfil all of the following conditions:

• Product is approved by comparable overseas regulators.
• Results of the approved release specifications or Certificate of Analysis is submitted.
• The product to be shipped and handled in accordance with the storage conditions specified in the approved package insert.
• The product should be used in accordance with the instructions provided in the approved package insert.
• Patient/legal guardian should be informed and consent should be obtained that the product is not registered with HSA and has not been evaluated for its quality, safety and efficacy by HSA.
• The therapy is approved by the respective clinical ethics committee and relevant professional board e.g. tumour board.
• Data should be collected on the safety and clinical outcomes. Serious adverse events should be reported to HSA.
• Maintain patient records for a period of 15 years (unless otherwise justified)

Application requirements

• Each unregistered CTGTP requires a separate application.
• The application form must be completed by the applicant who is the person importing the unregistered CTGTP.
• The doctor, dentist or the hospital, clinic or nursing home who is requesting for the unregistered CTGTP is referred to as the Requester.
• The Requester is required to sign a declaration that he or she assumes full responsibility for the use of the unregistered CTGTP on the patient.
• The Requester is not required to access the application form. However, the applicant must obtain the requester’s signed request before submitting the online application.
• Product labels, including outer and inner labels as well as package insert must be submitted for the first application, and are not required for subsequent applications for the same product, unless there are changes to the product labels. The labels must be in English and include the following details:
  1. Proprietary name of the CTGTP.
  2. Name and quantities of any active ingredient.
  3. Appropriate control number, such as a serial number, batch number or lot number.
  4. Expiry date.
• Upon successful submission of the application, you will receive an email acknowledgment containing the application details and an application number. For future correspondences with HSA regarding your application, please quote this application number.

Fees and turn-around-time

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

How to apply

Submit your application through the relevant application form. Ensure you have the following before submitting your application:

• CRIS company account
• CorpPass

You will be notified of the outcome of your application via email. For approved applications, the approval number would also serve as the import licence number for the import.