The use of unregistered therapeutic products 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 therapeutic product. Note: The safety, quality and efficacy of these unregistered therapeutic products are not assessed by us, hence requesting doctors are fully responsible for the use of such products on patients. Approval must be obtained for each consignment of the unregistered therapeutic product before it can be imported. The maximum quantity of each consignment cannot exceed a total of three months' supply per patient based on the recommended dose stated in the therapeutic product's package insert. We may consider an application for a quantity exceeding the specified maximum amount if it can be substantively justified based on medical needs. EligibilityYou can apply to import unregistered therapeutic products via this SAR if you are:
You will also need to apply for the licence to import and wholesale controlled drugs or for an approval to import therapeutic products containing psychotropic substances if your unregistered therapeutic product contains a controlled drug or a psychotropic substance, respectively. Application types
(a) To import and supply an unregistered therapeutic product which presents a life-saving treatment option to the patient whose condition would be clinically compromised without the requested therapy, and that there is no effective alternative therapy registered in Singapore. OR (b) To import and supply a novel unregistered therapeutic product which offers a substantive clinical advantage over registered therapies and is expected to provide significant improvement in the patient’s clinical outcome Important note: The application must be accompanied by the clinical justification(s) of unmet medical needs and reasons for not using current registered therapeutic products. Buffer Stock applicationTo import and supply the unregistered therapeutic product which is a standard essential medicine, to be kept as stocks in hospitals or clinics to meet the critical needs of Singapore’s healthcare system. Important note: Only medicines listed on the MOH Standard Drugs List or the Hospital Pharmacy and Therapeutics List are eligible for this category of application. Application requirements
Turn-around-timeThe target turn-around-time is 14 working days, excluding stop-clock time when we request for clarification or additional information. You will be notified of the outcome of your application via email. For approved applications, the unique reference number would also serve as your consignment approval number. FeesFee is not applicable. How to applySubmit your application using the Online Application form for Consignment Approval of Unregistered Therapeutic Product for Patients' Use. Ensure you have the following credentials before you access the e-service: Changes cannot be made to the application form once submitted. If you have made errors in your submission, you can withdraw the application and re-submit using a new application. To withdraw your application, please notify us at [email protected] and quote the application number. More details on submission requirements may be found in our Guidance on Therapeutic Products Registration. |