JANUARY 11, 2022

Resolution No. 28/2022 of the National Ministry of Health: procedure for reporting self-assessment tests for the detection of SARS-CoV-2, and commercialization conditions



Healthcare & Life Sciences Department Report | Resolution No. 28/2022 of the National Ministry of Health: procedure for reporting self-assessment tests for the detection of SARS-CoV-2, and commercialization conditions. 

Dear Sir or Madam,

On January 10, 2022, the National Ministry of Health issued Resolution 28/2022 published on January 11, 2022, in the Official Gazette (the “Resolution”), which approved the procedure for reporting the use and notification of results of individual self-assessment tests for the detection of SARS-CoV-2 (the “Autotest”) and established the conditions for their packaging and commercialization.

In line with Dispositions 120/2021, 121/2021, 122/2021, and 123/2021 of the National Administration of Medicines, Food and Medical Technology (“ANMAT”), which authorized the use of the so-called “rapid antigen tests” for the detection of COVID-19 or immunochromatographic tests for SARS-CoV-2 antigens for professional use and those designed for self-testing, and due to the relevant number of COVID-19 detection tests that have been performed recently, the Resolution regulates the commercialization and administration of the Autotest.

Please find below a brief summary of the main points of the Resolution:

• The “Procedure for the Reporting of the Use and Notification of the Result of the Individual Self-Assessment Tests for the Detection of Sars-Cov-2 (Covid-19)” was approved, according to which:

1. Self-test results must be reported on an individual basis within 24 hours of being opened, and within 7 days of being acquired when unused, either by the individual user or by a reporting officer in the case of large test volumes. It is the responsibility of the user to report the result of the self-test.

2. In the event that the product is acquired (i) by a user in an authorized pharmacy, the report of use must be made to the pharmacy where the product was acquired, (ii) by a public or private institution, they must designate a health referent responsible for the report of use, and report the destination and results to the place of acquisition or to the health authorities of their jurisdiction.

3. Pharmacies shall notify the results of the Autotest dispensed to the National Health Surveillance System (“SNVS”, for its acronym in Spanish), who shall store the data.

4. If the pharmacist does not receive the report from the user 24 hours after it was opened or within 7 days of the purchase when they have not been used, the pharmacist must report this situation to the jurisdictional health authority.

5. Failure to comply with point 4 above will result in the disqualification of the point of sale for the dispensing of the Autotest.

• It was established that the Autotest must be approved by ANMAT prior to their commercialization, since they are considered “medical products for in vitro diagnosis”.

• Autotest must be marketed with only one test per sales package, with an identification number, barcode or additional QR code to facilitate the subsequent reporting of the result and its uploading. In case the package has more than one test, it must have the individual identification of each one of them.

• The instruction manual or “instructions for use” of the Autotest should establish simple and clear indications for the performance of the test and the interpretation of the results, including explanatory figures or diagrams for users to help in the correct use. In addition, they should include indications for discarding the product, special care and clarifications on the risks of using the product.

Please contact us for any additional information.

Ana Andrés
Julieta Gonzalez