On January 11th, 2022, Resolution No. 28/2022 issued by the National Ministry of Health (the “Resolution”), established the procedure for the reporting of the COVID 19 self- tests, and its notification to the National Health Surveillance System (“SNVS” for its acronym in Spanish).
The self-assessment tests may be purchased by individuals or by public or private institutions.
Individuals may purchase the self-assessment tests only in pharmacies. Drugstores, distributors and laboratories that supply the retail channel may only sell the self-assessment tests to pharmacies that comply with the procedure established by the Resolution.
Public or private institutions may acquire and/or use the SARS-CoV-2 (COVID-19) self-tests for under the conditions established by the jurisdictional health authority. Any public or private institution using such tests, must designate a health professional that will be responsible for informing the destination, use and report the results to the health authorities of their jurisdiction to be notified to the SNVS.
The national health authority and the jurisdictional health authority that adheres to the procedure established by the Resolution, may disqualify the point of sale for the dispensing of COVID 19 self-tests in case that the results have not been reported.
The Resolution also established the packaging and product conditions of the COVID 19 self-tests.
PROCEDURE FOR REPORTING THE USE OF COVID 19 SELF- TEST AND ITS NOTIFICATION TO THE NATIONAL HEALTH SURVEILLANCE SYSTEM (SNVS)
PROCEDURE FOR REPORTING USE OF THE TEST
Deadline for reporting:
The test results must be reported individually (according to the bar code of each package) within 24 hours after the test has been performed, and within 7 (seven) days after it has been acquired if they have not been used.
The report shall be made by the individual user or by the person in charge of the report.
To whom it is reported:
If the product is purchased by a user in an adhering pharmacy, the report of use is always made to the pharmacy where the product was acquired, for which the user will have the following alternative channels: directly at the point of sale (pharmacy) or by telephone, by the website and others that may be established.
In case the product is acquired and/or used by a public or private institution, they must designate a healthcare professional responsible for (i) use reporting ; (ii) informing the destination and results to the place of acquisition or to the health authorities of their jurisdiction.
NOTIFICATION OF THE RESULT
- a) Pharmacies shall report the results to the SNVS.
- b) Public or private institutions that acquire or use the COVID 19 self-tests must notify the results to the SNVS through the authorized users. When the report of use was made to the health authorities of their jurisdiction, the latter must notify the results to the SNVS.
DATA SUBMISSION:
a. Data to be collected
First name, Last name, Legal sex, Date of birth, Type of document, Document number, Full address, Contact telephone number.
Test result: positive / negative
Additionally, the configuration parameters to be provided by the Directorate of Epidemiology should be sent.
b. Database
These data will be stored in the pharmaceutical computer database and will be reported to the SNVS by the authorized pharmaceutical groups, in the case of test reports from individual users or public or private institutions.
If the pharmacist does not receive the result report within 24 hours after being performed, and within 7 (seven) days after being purchased, it must be informed to the jurisdictional health authority. That point of sale for COVID 19 self-tests could also be disqualified if it is noticed that the SNVS has not been uploaded.
At a jurisdictional level, in the case of health care providers, the data will be registered directly in the SNVS through the authorized users.
RESPONSIBILITIES
a. Users will be responsible for reporting the results to the pharmacy through any of the channels enabled for this purpose. b. Pharmacists will be responsible for recording the dispensed tests, their results and the identification of users in the pharmacy information system. The pharmaceutical groups will be responsible for the notification to the SNVS. c. Adhering jurisdictions will be responsible for the notification of cases directly to the SNVS through enabled users.
CLASSIFICATION:
Positive cases will be integrated into the notification of COVID-19 cases in the SNVS and will be classified as “probable cases”, negative cases will be classified as “negative, unclassified”.
Invalid test cases must be repeated to define the result. A case classified as “probable” must comply with the recommendations issued by the health authority of the jurisdiction in force at the time of testing.
PACKAGING AND PRODUCT CONDITIONS
The COVID-19 self-tests:
- a) Must be approved by ANMAT prior to their commercialization since they are considered “medical products for in vitro diagnosis” according to ANMAT Resolution No. 2674/99 and its amendments.
- b) The marketable product must contain only one test per sales package, with an identifying number, barcode or additional QR code that facilitates 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.
- c) The instruction manual or “instructions for use” must establish simple and clear indications for the performance of the test and the interpretation of the results, including explanatory figures or diagrams that help the correct use.
In addition, they must include indications for disposing the product, special care and clarifications on the risks of using the product.
