Increasing Access to ART Test Kits
MOH had earlier announced that Over-the-Counter Antigen Rapid Tests (OTC ARTs) would be made available at designated local retail pharmacies from 16 June 2021.
From 16 July 2021, we will extend the sale of these ART self-test kits to more general retailers like supermarkets and convenience stores. We will also lift the restriction that caps OTC ART sales at 10 kits per individual. With this, more individuals, particularly those who do not have acute respiratory infection symptoms, can test themselves if they are concerned about potential exposure to COVID-19.
The following ARTs have been authorized by HSA under Pandemic Special Access Route (PSAR)1:
1 PSAR is an interim authorization to supply an "emergency medical device" under regulation 13C of the Health Products (Medical Devices) Regulations. (Please refer to this link for details)
The 5 companies that have been granted PSAR authorization will be exempted from possessing the requisite wholesale license under the HPA in supplying the self-administered ARTs to pharmacies/retail stores/ecommerce platforms. However, they are subjected to the prescribed duties and obligations imposed on licensed wholesale suppliers under the Medical Device Regulations.
Please refer to this for more details on self testkits and latest COVID-19 related information and consumer advisories.
https://www.hsa.gov.sg/consumer-safety/articles/covid19_ARTselftests
https://www.hsa.gov.sg/covid-19-information-and-advisories
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