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Special Access Route for Unauthorised COVID-19 Vaccines

Hospitals or clinics need approval from us before importing unauthorised COVID-19 vaccines for vaccinating patients under their care.

1.Introduction

This Special Access Route (SAR) applies only to COVID-19 vaccines that are granted Emergency Use List (EUL) by the World Health Organization (WHO) and have not been authorised under the Pandemic Special Access Route (PSAR) by HSA, i.e. non-PSAR authorised vaccines.
 

2.Eligibility

You can apply to import unauthorised COVID-19 vaccines via this SAR if you are a licensed healthcare institution (HCI) in the private healthcare sector and the vaccines are for the use by your own doctors on patients under their care.
 

3.Conditions for using this SAR

This SAR for licensed HCI to import and supply non-PSAR authorised vaccines that are granted EUL by WHO remains in force until such time as HSA's PSAR authorisation for COVID-19 vaccines in Singapore ceases. 

It is subject to the following conditions:

1. The application is made by licensed HCI and registered medical practitioners, hereinafter referred to as the “applicant”, for their patients who require an alternative COVID-19 vaccine to the currently authorised vaccines by the HSA under the PSAR; 

2. The application is made only for the import and supply of vaccines approved under the WHO EUL as at the date of the application and procured from WHO EUL-approved manufacturing sources only; 

3. The vaccines must be used according to WHO EUL’s approved age groups and indications; 

4. The total quantity requested in the application must not exceed the total number of doses required for a maximum supply period of 3 months by the applicant; 

5. The SAR approval to import the WHO EUL vaccines in Singapore is valid for a period of 6 months from the date of approval;

6. The applicant must undertake that he is fully aware of the associated risks and takes full responsibility for using the vaccines on the patients under his care. The risks include: 

  • The vaccines have not been evaluated for the required quality, safety and efficacy standards for  import and supply in Singapore by HSA; and
  • The vaccines are not subject to HSA’s enforcement and compliance checks on whether they are adulterated, counterfeit or substandard. 

7. The applicant must, upon becoming aware of any serious adverse reaction* arising from the use of the vaccines, report the serious adverse reaction to HSA immediately in no later than 15 days;

8. The applicant must obtain signed informed consents from the patients, and ensure that patients acknowledge the following: 

  • The patients have discussed the risks and benefits of using vaccines not authorised by HSA with their doctor, and accept all responsibility for the risks described in paragraph 6; and
  • The patients are aware of Ministry of Health (MOH)’s directive that they will not be eligible for the Vaccine Injury Financial Assistance Programme for COVID-19 Vaccination (VIFAP) should any serious adverse events occur; and may not be treated in the same manner as those vaccinated with PSAR-authorised vaccines for the purpose of public health measures such as travellers and pre-event testing concessions. 

9. The applicant must comply with MOH’s instructions on the following: 

  • The recipients of the unauthorised vaccine must be notified to the National Immunisation Registry as soon as possible within 72 hours, with information on the brand name and batch number of the vaccine administered; and
  • The applicant must furnish information on the vaccination brand, vaccination sites and start date of vaccination to MOH.

*Serious adverse reactions which: (i) are life-threatening or fatal, (ii) require in-patient hospitalisation or prolong existing hospitalisation, (iii) cause persistent incapacity or disability, (iv) cause birth defect, or, (v) are assessed to be medically significant that may jeopardise the person’s health or may require intervention to prevent the person’s death or one of the other outcomes in (ii) to (iv).

4.How to apply

You can submit an application via this SAR if you are a registered medical practitioner.

Submit your application using the Online Application Form.
 
Ensure you have the following credentials before you access the e-service:
Changes cannot be made to the application form once submitted. If you wish to amend the application after submission, you can withdraw the application and re-submit using a new application. To withdraw your application, please notify us at HSA_TP_SAR@hsa.gov.sg and quote the application number.
 
The application outcome will be sent to the HCI’s contact email address listed in the application form. Please ensure that the email address is entered correctly.


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