TESTING OF COVID-19 REGULATIONS

SUBSIDIARY LEGISLATION 458.61

TESTING OF COVID-19 REGULATIONS

10th September, 2021

LEGAL NOTICE 357 of 2021, as amended by Legal Notice 118 of

2022.

The title of these regulations are the Testing of COVID-

19 Regulations.

Data to be submitted to the Superintendent with each notified test

result

(a)

tested person’s identification document number (in

order of preference: Malta identity card number or passport

number or Malta hospital identity number);

(b)

tested person’s first name and surname;

(c)

tested person’s date of birth;

(d)

tested

person’s

sex

according

to

official

documentation;

(e)

tested person’s nationality;

(f)

tested person’s contact number in Malta (a mobile

number is preferred);

(g)

tested person’s email address (when available);

(h)

tested person’s postal address in Malta;

(i)

test type;

(j)

test name (only in case of rapid antigen test);

(k)

test manufacturer (only in case of rapid antigen

test);

(l)

testing facility name;

(m)

test result;

(n)

test reason (only in case of rapid antigen test);

(o)

test specimen collection date and time; and

(p)

test result date and time (only in case of nucleic

acid amplification test).

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.

(1)

COVID-19 Testing is to be carried out in line with

these regulations and any other applicable regulations. For the

avoidance of any doubt these regulations shall apply to all health care

professionals, health care workers and designated premises whether

operating within the public health system or otherwise

Provided that regulation 9 shall not apply to antibody

tests and devices for self-testing.

(2)

Any health care professional who performs a Point-of-

Care Test for COVID-19 shall follow the Standards - Point-of-Care

Rapid Antigen for SARS-CoV-2 issued by the Superintendent under

article 4(c) of the Public Health Act.

Any person intending to carry out a Point-of-Care Test for

COVID-19 shall

(a)

do so on designated premises;

(b)

use a Point-of-Care Test for COVID-19 that is

approved by the Authority;

(c)

be a health care professional or a health care

worker working under the direct supervision of a health care

professional; and

(d)

comply with the reporting obligations laid down

in regulation 9.

(1)

Any person who wishes to designate their

premises for the carrying out of Point-of-Care Tests for COVID-19

shall submit an application to the Authority indicating

(a)

the name and address of the premises;

(b)

the name, surname and contact details of the

responsible health care professional; and

(c)

a declaration that the premises meet the general

safety and performance requirements set out by the Authority.

(2)

Where a person to be tested is house bound or

quarantined, a Point-of-Care Test for COVID-19 may, in exceptional

circumstances, be carried out at the person’s residence by a health care

professional. In these cases, reporting of the test result shall still be

required and must be submitted through COVID Result Submission

Malta.

(3)

The Authority shall issue a certificate of approval for

each designated premises pursuant to these regulations, and no

premises shall be permitted to commence such testing unless so

approved.

(1)

The Authority shall monitor and review any

operations conducted within designated premises to ensure that they

are carried out in accordance with the provisions of these regulations

and in compliance with any decision taken by the Authority.

(2)

For the purposes of this regulation, the Authority or any

person so authorised, shall have the right at all reasonable times and,

where necessary, with the assistance of the Executive Police, to enter

and inspect any designated premises.

(1)

Any person who wishes to place a COVID-19 Test

Kit on the Maltese market shall submit an application to the Authority

for approval.

(2)

A list of approved COVID-19 Test Kits shall be

published in the Gazette by the Superintendent which list shall also be

made available on the official COVID-19 website.

The Authority shall issue its approval or rejection for

designated premises and point-of-care tests and Point-of-Care Tests for

COVID-19 and devices for self-testing following the consideration of

all relevant documents, and any other information as may be deemed

necessary in order to ensure fulfilment of the authorisation

requirements submitted by the applicant

Provided that the Authority may, in its own discretion,

request additional information and samples it deems necessary for the

evaluation of the application.

Any health care professional who performs COVID-19

Testing shall, without prejudice to any regulation herein, be required to

report the results of all tests carried out and related personal data to the

Superintendent for each test and shall also report all details pursuant to

the Schedule using the COVID Result Submission Malta

Provided that health care professionals forming part of

Malta’s public health system and health care workers working in

Malta’s public health system under the direct supervision of a health

care professional shall not be required to submit test results through

COVID Result Submission Malta if they have already been submitted

through another public health information system.

The Authority may, where it so deems necessary, restrict

market access to COVID-19 Test Kits in the interest of public health

and in accordance with the In Vitro Diagnostic Medical Devices

Regulations

Provided that COVID-19 Test Kits and devices for self-

testing may be made available to the public by distributors in accordance

with the standards published by the Superintendent.

In the advertising of COVID-19 Test Kits, it shall be

prohibited to use text, names, trademarks, pictures and figurative or

other signs that may mislead the user or the person to be tested with

regard to the device's intended purpose, safety and performance

Provided that any advertisements which are in violation

of these regulations shall be amended, replaced or removed as

necessary.

(1)

Nothing in these regulations shall prejudice the

applicability of the Regulation (EU) 2016/679 and the Data Protection

Act and the fundamental rights and freedoms of data subjects.

(2)

Where the Superintendent in his capacity of a controller

processes the personal data listed in the Schedule through the COVID

Result Submission Malta for reasons of public interest in the area of

public health pursuant to Articles 6(1)(e) and 9(2)(i) of Regulation

(EU) 2016/679, he shall

(a)

comply with all the principles relating to the

processing of personal data pursuant to Article 5(1) of

Regulation (UE) 2016/679; and

(b)

apply appropriate technical and organisational

measures to ensure a level of security appropriate to the risk

posed, and prevent abuse or unlawful access to or transfer of,

personal data pertaining to the data subjects.

(3)

The controller shall only process personal data which is

strictly necessary for the purposes of these regulations

Provided that the controller shall retain the personal data

of the data subjects, including the information in relation to the test

performed on the data subjects for the purposes of these regulations,

for a period of two (2) years from the date of the performance of the

test.

(4)

Data subjects shall have the right to exercise their data

protection rights pursuant to Chapter III of Regulation (EU) 2016/679

in relation to any personal data processed by the controller.

Whenever, after assessing the circumstances surrounding

COVID-19, the Superintendent deems that the use of COVID Result

Submission Malta is no longer necessary, the Superintendent shall

(a)

decommission COVID Result Submission Malta;

and

(b)

cease to process any personal data under these

regulations.

Any person who fails to abide by the provisions of these

regulations shall be guilty of an offence and shall, on conviction, be

liable to the payment of a penalty of not less than one hundred euro

(€100) and not more than five hundred euro (€500) for each and every

instance in which these regulations are breached.