COVID-19 Test Kit in the Philippines: ‘authorization validity’ extension
The Food and Drug Administration (FDA) of the Philippines has issued an amendment to FDA Circular No. 2021-023 extending the current validity of market authorizations, Special Certification, for COVID-19 Test Kits, from 31 December 2021 to 31 January 2022. This extension is valid ONLY for COVID-19 Test Kits whose marketing authorization holder applied for re-issuance of the authorization on or before 23 September 2021 and who is currently awaiting the performance validation test results from the Research Institute of Tropical Medicine (RITM).
This extension was communicated in FDA Circular No. 2021-23A, issued on 28 December 2021. If additional extensions of the Special Certification are required, then these may be issued through an FDA Advisory. All supplementary or added requirements of FDA Circular No. 2021-023 not affected by this amendment shall continue in effect. This circular shall take effect instantly and shall continue to be valid unless otherwise canceled, repealed, or withdrawn.
Click here for FDA Circular no. 2021-023A from the Philippines FDA.
Learn about the Performance Requirements for Covid-19 Test Kits in the Philippines.
Learn about the Process for Covid-19 Test Kit Applications.
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