Conditions for using this special access route (SAR)
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 or dentists 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.
Eligibility
You can apply to import unregistered therapeutic products via this SAR if you are:
- A licensed hospital, clinic or nursing home* importing the drug 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 an importer's licence and a wholesaler's licence from us prior to the import. At least one qualified pharmacist must be named as the responsible person in the import licence.
*Specified healthcare service licensee under the Healthcare Services Act 2020; nursing home licensee under the Private Hospitals and Medical Clinics Act 1980
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
- The application type is determined by the purpose of the request as follows:
| Type of application |
Purpose of the request |
| Named-Patient |
(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 notes:
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. Quantities exceeding the specified maximum amount may be considered if it can be substantively justified based on medical needs.
The application must be accompanied by the clinical justification(s) of unmet medical needs and reasons for not using current registered therapeutic products. The conditions for using this SAR are as follows:
(i) The clinician must obtain and document informed consent from the patient or patient’s guardian for the use of the unregistered therapeutic product on the patient;
(ii) The clinician must furnish a declaration that the use of the unregistered therapeutic product complies with the Ministry of Health’s allowable practice and applicable law;
(iii) The clinician must furnish a declaration that the use of the unregistered therapeutic product complies with the clinical practice allowed under the Singapore Medical or Dental Council’s Ethical Code and Ethical Guidelines.
Applications seeking to import/supply an investigational therapeutic product* that is still undergoing testing in clinical trial should be accompanied by documentary proof of professional consensus in accordance with Singapore Medical Councils’ Ethical Code and Ethical Guidelines Section B6 paragraph 4 on the use of innovative therapies in a dire clinical situation.
*Investigational therapeutic product refers to an unregistered therapeutic product:
i. Which is not approved by any HSA’s reference agency; or
ii. Which is rejected/ withdrawn/ pending deferral for safety or efficacy reasons by any HSA’s reference agency; or
iii. Where the clinician’s intended use is not approved by any HSA’s reference agency and not documented in established clinical practice guidelines nor accepted in current clinical practice as standard of care.
|
Buffer Stock
|
To import and supply the unregistered therapeutic product which is a standard essential medicine, to be kept as stocks in hospitals, clinics or nursing homes 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
- Each unregistered therapeutic product requires a separate application form.
- The application form (Sections A to E) must be completed by the applicant who is the person importing the unregistered therapeutic product.
- The doctor, dentist, pharmacist or the hospital, clinic or nursing home who is requesting for the unregistered therapeutic product is referred to as the Requester.
- Up to 2 requests for the same application type (Named-Patient or Buffer Stock) and for the same product can be submitted in one application.
- Each application must be accompanied by the respective Signed Request(s) for the relevant application type which are completed and signed by each Requester. The Requester is required to sign a declaration that he or she assumes full responsibility for the use of the unregistered therapeutic product on the patient. To download the Signed Request forms, click here or on the following links:
- 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:
- Proprietary name of the therapeutic product.
- Name and quantities of any active ingredient.
- Appropriate control number, such as a serial number, batch number or lot number.
- Expiry date.
- Declaration that the product contains tartrazine, benzoic acid or sodium benzoate, if applicable.
- Upon successful submission of the application, you will receive an email acknowledgment containing the application details and a unique reference number. For future correspondences with HSA regarding your application, please quote this reference number.
- The unique reference number is a 24 alpha-numeric character, e.g. “Ref: 5d42d72a2779ec00138908c1”.
Turn-around-time
The 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.
Fees
Fee is not applicable.
How to apply
Submit 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 using the online application enquiry form.
Refer to our Guidance for Import and Supply of an Unregistered Therapeutic Product for Patient Use for more details.