Import and supply of unregistered Class 2 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 would be clinically compromised without treatment with the unregistered Class 2 CTGTP.

Note: The safety, quality and efficacy of these unregistered Class 2 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 an 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:

• The product is approved by at least one of HSA’s comparable overseas regulators.

• You are required to submit the results of the approved release specifications or Certificate of Analysis.

• The product is to be shipped, handled and used in accordance with the storage conditions and instructions specified in the approved package insert.

• The patient/legal guardian should be informed and consent should be obtained that the product is not registered with HSA and has not been evaluated by HSA for its quality, safety and efficacy.

• 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.

• Patient records should be maintained for a period of 15 years (unless otherwise justified)

Comparable overseas regulators

HSA's comparable overseas regulators consist of the following:

• Australia Therapeutic Goods Administration (TGA)

• Health Canada (HC)

• US Food and Drug Administration (FDA)

• European Medicines Agency (EMA)

• UK Medicines and Healthcare Products Regulatory Agency (UK MHRA)

Application requirements

• Each unregistered CTGTP requires a separate application.

• You will need to submit the following supporting documents in your application:

  • Request Form completed by the requester, i.e., the doctor or dentist of the hospital, clinic, nursing home requesting for the unregistered Class 2 CTGTP. 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.

  • Product labels, including outer and inner labels as well as package insert. The labels must be in English and include the following details:

    • Proprietary name of the Class 2 CTGTP.

    • Name and quantities of any active ingredient.

    • Appropriate control number, such as a serial number, batch number or lot number.

    • Expiry date.

Fees and turnaround time

Refer to CTGTP fees and turnaround time for more information.

How to apply

Submit your application through SHARE.