ARGENTINA

On January 11, the Ministry of Health approved the procedure for the reporting of the use and notification of results and the packaging and product conditions of the Covid 19 self-test. Previously, ANMAT authorized the individual use of four self-testing tests based on the detection of the SARS-CoV-2 virus from Roche, Abbott, Vyam Group and Wiener laboratories.  The Ministry indicated that the sale of the self-tests will be “exclusively in pharmacies”.

The Health Ministry informed that the self-testing tests for the detection of Covid 19 can be purchased individually, by public or private institutions or jurisdictions, as long as the adequate reporting of the results is guaranteed. At the same time, the health authority clarified that the approved products are diagnostic-oriented and allow users to collect the sample by themselves based on the manufacturers’ instructions.

Regarding notification, the results must be reported immediately, based on the barcode on each package, within 24 hours of the test. The data will be stored in the pharmaceutical database and will be reported to the National Health Surveillance System (SNVS in Spanish) by the authorized pharmaceutical groups, in the case of test reports from individual users or by public or private institutions.