S.L. 458.61 Art. 2Interpretation.

In these regulations, unless the context otherwise requires:

"Act" means the Medicines Act;

"Authority" means the Medicines Authority established under article 4 of the Act;

"COVID-19" means a disease caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) virus;

"COVID Result Submission Malta" means the COVID-19 Result Submission Web Application;

"COVID-19 Test Kit" means an in-vitro diagnostic device that consists of reagents or articles, or any combination of these, and that is intended to be used to conduct a specific test for the identification of the presence of SARS-CoV-2 or any other marking agent related to it;

"COVID-19 Testing" means testing for the SARS-CoV-2 virus by means of a nucleic acid amplification test, a rapid antigen test, or an antibody test;

"designated premises" means any premises designated pursuant to regulation 5;

"device for self-testing" means any testing device for the identification of the presence of COVID-19 or any other marking agent related to it and which is intended by the manufacturer to be used by persons not acting within the capacity of health care professionals or health care workers or not carrying out COVID-19 Testing within designated premises;

"health care professional" shall have the same meaning as assigned to it by article 2 of the Health Care Professions Act;

"health care worker" means a person who is trained to deliver care and services to the sick and ailing but who is not a health care professional;

"nucleic acid amplification test" or "NAAT" means a type of viral diagnostic test for COVID-19 which specifically identifies the RNA (ribonucleic acid) sequences that comprise the genetic material of the virus, including but not limited to a reverse transcription polymerase chain reaction (RT-PCR) test;

"Point-of-Care Test for COVID-19" means any test that does not require the submission of the test specimen to a laboratory and that is intended to be used to detect and identify the presence of SARS-CoV-2 or any other marking agent related to it, excluding devices for self-testing;

"rapid antigen test" or "RAT" means a rapid diagnostic test suitable as a COVID-19 Test Kit that directly detects the presence or absence of SARS-CoV-2 antigen;

"Regulation (EU) 2016/679" means Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on the protection of natural persons with regard to the processing of personal data and on the free movement of such data, and repealing Directive 95/46/EC (General Data Protection Regulation);

"Superintendent" shall have the same meaning as assigned to it by the Public Health Act.