Testing of COVID-19 Regulations, 2021

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,698, 10 ta’ Settembru, 2021

L.N. 357 of 2021

MEDICINES ACT

(CAP. 458)

Testing of COVID-19 Regulations, 2021

IN EXERCISE of the powers conferred by article 106 of the

Medicines Act, the Minister responsible for public health, after

consultation with the Licensing Authority, has made the following

regulations:-

The title of these regulations are the Testing of COVID-19 Citation.

Regulations, 2021.

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).

€0.27

In these regulations, unless the context otherwise requires

Interpretation.

"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;

"rapid antigen test" or "RAT" means a rapid diagnostic

test suitable as a Point-of-Care Test for COVID-19 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.

(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 Designated

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

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 Monitoring and

operations conducted within designated premises to ensure that they review

operations.

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 List of approved

Kit on the Maltese market shall submit an application to the Authority COVID-19

Kits.

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 COVID-19 Test Kits 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 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.

(1) 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.

(2) Devices for self-testing shall not be made available, put

into service, distributed or used in Malta.

(3) The sale of COVID-19 Test Kits by distributors directly to

the public shall be prohibited.

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 Decommission

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

application.

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 Offences and

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

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.

The Delivery and Testing of COVID-19 using Point-of- Repeal and

Care Rapid Testing Regulations are hereby repealed and this without saving.

S.L.458. 60.

prejudice to the validity of anything done or omitted to be done on the

basis thereof.