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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 at your HCI by your own doctors on patients under their care.
 

The following restrictions apply:

1. The total requested quantity of non-PSAR authorised COVID-19 vaccine does not exceed 5,000 doses per HCI per 1-month block (from the date of the application) and must not exceed the total number of doses required for a maximum supply period of 3 months by the applicant.

2. Each application is applicable only to one brand of unauthorised COVID-19 vaccine.

3. The unauthorised vaccine must be procured from WHO EUL-approved manufacturing sources.

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 requested quantity of non-PSAR authorised COVID-19 vaccine does not exceed 5,000 doses per HCI per 1-month block (from the date of the application) and 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: 

a) The vaccines have not been evaluated for the required quality, safety and efficacy standards for  import and supply in Singapore by HSA; and

b) 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: 

a) 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

b) 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: 

a) 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;

b) The applicant must furnish information on the vaccination brand, vaccination sites and start date of vaccination to MOH;

c) The licensed HCI must ensure that there is proper segregation of different type(s) of COVID-19 vaccine(s) and corresponding vaccination protocols are instituted to prevent mix-up. Note: Medical Clinics cannot provide COVID-19 vaccines under SAR together with national COVID-19 vaccination services in the same premises; and

d) The licensed HCI must only accept online or telephone appointments for COVID-19 vaccination at the premises and not allow walk-ins. 

*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. Declaration and Undertaking

Applicants must declare and undertake to fully comply with the restrictions and conditions set out in the application form when making an application to HSA, which include:

Declaration and Undertaking
                                              
The licensed HCI must declare that the information submitted in this application is true and accurate to the best of my knowledge. 

The licensed HCI must undertake to immediately notify the Health Sciences Authority of any changes in the information and particulars submitted in this application. 

The licensed HCI must undertake to fully comply with:

  • the restrictions on maximum quantity and vaccine manufacturing sources detailed in Section 2 above; and

  • all the conditions detailed in Section 3 above, in particular, MOH’s requirements concerning the administrative protocols set out at paragraphs 9(a) to (d) of the said Section. 
The licensed HCI accepts that any failure to comply with the above-stated restrictions and conditions may render the applicant and/or the licensed HCI liable to regulatory action and/or prosecution under the relevant legislation, including but not limited to the Health Products Act and Health Products (Therapeutic Products) Regulations. The applicant is also aware that it is a criminal offence to make any false statements or provide any false or inaccurate information to the Health Sciences Authority in respect of this application   

 

5. 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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