COVID-19 Antibody Test Kits online sales banned by Philippines FDA

2020-06-02T01:05:05+08:00 June 2nd, 2020|Insight, Medical Regulation Updates, News & Events|
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On 8 May 2020, the Philippines’ Food and Drug Administration issued Circular 2020-016 to remind all stakeholders (manufacturers, health facilities, and the general public) that the online selling of FDA Certified COVID-19 Antibody Test Kits is strictly prohibited.

This Circular complements prior Advisory notice no. 2020-497  to Market Authorization Holders (MAH) of COVID-19 antibody test kits (rapid test, point-of-care, lateral flow, Elisa, GICA, CLIA among others) that have obtained FDA special certification, that they are strictly for medical professional use and not intended for personal use, hence the reason for banning COVID-19 antibody test kits online sales.

The Circular also complements prior Advisory notice no. 2020-498 issued to inform the general public on the purchase and administration of all FDA certified COVID-19 antibody test kits. These products must be obtained on prescription from a licensed physician from licensed hospitals or drugstores/pharmacies/botica. Online sale is prohibited. The test must be administered by a doctor or a trained health professional. And interpretation of the result must be guided by a physician. The general public can report incidents regarding the improper dispensing and use of COVID-19 Rapid Antibody Test Kits by sending any relevant information such as the source, product name, importer/distributor to the following email address: covidresponse@fda.gov.ph.

Further to the Republic Act No. 9711, otherwise known as the “Food and Drug Administration Act of 2009”, it is government policy to ensure the safety, efficacy and quality of IVD medical devices in the country in order to protect the health of the Filipino people. This means that all FDA Regional Field Offices and Regulatory Enforcement Units have been instructed to carry out exhaustive monitoring of all online platforms to ensure full compliance of this Circular undertaking enforcement actions as necessary.

If you have any queries regarding COVID-19 antibody test kits online sales or our services for medical device registration and representation in the Philippines, please contact us at contact@andamanmed.com.