On the 12th February 2021, Legal Notice 49 of 2021 - MEDICINES ACT (CAP. 458) - Delivery and Testing of COVID-19 using
Point-of-Care Rapid Testing, Regulations 2021 - was published. On 10th September 2021, this was superseded by Legal Notice 357 of 2021 - Testing of COVID-19 Regulations, 2021. Through this legislation, the performance of Point-of-Care Rapid Antigen Tests for SARS-CoV-2 (RATs) is regulated as follows:
- All RATs will have
to be performed on designated premises which are certified by the Medicines
Authority.
- Only RAT kits which
are approved by the Superintendence of Public Health may be used, which list
will be published in the Government Gazette by the Superintendent of Public
Health. The approved RAT tests are continuously being updated. For the most recently updated list kindly contact the Malta Medicines Authority. Providers may make submissions to the Medicines Authority to place new
RAT kits on the market.
- Only registered
health care professionals or health care workers working under the supervision
of a health care professional may administer RATs.
- All RAT results
must be submitted to the Superintendent of Public Health via a web application.
- Devices for
self-testing are allowed. The sale of self-tests for Covid-19 is limited to pharmacies across Malta and Gozo. Self-Tests for Covid-19 need to be approved by the Malta Medicines Authority. A national list of Covid-19 self-tests approved by the Malta Medicines Authority (MMA) can be found https://medicinesauthority.gov.mt/medicaldevices. Refer to the Standards for the importation, sale and use of devices for self-testing for Covid-19 by the public for more information.
- Advertising will be
regulated to prevent misleading adverts.
Standards on the use of Point-of-Care Rapid Antigen Tests for SARS-CoV-2
LN 49 of 2021 was accompanied by Standards on the use of Point-of-Care Rapid Antigen Tests for SARS-CoV-2 which are issued under the Public Health Act Chapter 465 of the Laws of Malta and the Prevention
of Disease Ordinance Chapter 36. These standards provide the procedural and regulatory requirements to carry out RAT testing for the SARS-CoV-2 virus and apply to all healthcare professionals who administer and manage the results of RATs and to patients who present to and undertake these tests.
COVID Result Submission Malta web application
Any healthcare professional who performs a Point-of-Care Rapid Test for COVID-19 shall be required to report the results and related personal information of all tests carried out to the Superintendence of Public Health using the COVID Result Submission web app. This is available at https://covidrapidtest.gov.mt for registered healthcare professionals. The Privacy Policy of the web application is available here, and answers to Frequently Asked Questions (FAQs) are available here.