Testing, Regulations 2021

L.N. 49 of 2021

MEDICINES ACT

(CAP. 458)

Delivery and Testing of COVID-19 using Point-of-Care Rapid

Testing, Regulations 2021

IN EXERCISE of the powers conferred by article 106 of the

Medicines Act, the Minister responsible for public health, with the

concurrence of the Superintendent of Public Health and after

consultation with the Information and Data Protection Commissioner

and the Medicines Authority, has made the following regulations:-

The title of these regulations is the Delivery and Testing of

COVID-19 using Point-of-Care Rapid Testing, Regulations 2021.

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 Rapid Testing Malta" means the COVID-19 Rapid

Antigen Point-of-Care Test Reporting 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;

"designated premises" means any premises designated pursuant

to regulation 4;

"device for self-testing" means any testing device for the

identification of the presence of SARS-CoV-2 or any other marking

agent related to it which is intended by the manufacturer to be used by

lay persons;

"health care professional" means a person who is authorised in

accordance with the provisions of the Health Care Professions Act as a

medical practitioner, dental surgeon, midwife, nurse, pharmacy

technician or pharmacist;

"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;

"Point-of-Care Rapid Test for COVID-19" means any test that is

carried out at the Point-of-Care 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;

"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.

Any person intending to carry out a Point-of-Care Rapid Obligations to

carry out test.

Test for COVID-19 shall

(a)

do so on designated premises;

(b) use a COVID-19 Test Kit that is approved by the

Authority;

(c) be a health care professional or be a health care

worker working under the direct supervision of a health care

professional; and

(d) comply with the registration obligations laid down in

regulation 8.

(1) Any person who wishes to designate their premises Designated

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

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 meets the general

safety and performance requirements set out by the Authority.

(2) Where a patient is house bound or quarantined, a Point-of-

Care Rapid Test for COVID-19 may, in exceptional circumstances, be

carried out at the patient’s residence by a health care professional. In

these cases, registration of the test still needs to be done through the

COVID Rapid Testing Malta.

(3) The Authority shall issue a certificate of approval for each

premises which is designated to carry out Point-of-Care Rapid Tests

for COVID-19 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 Superintendence of Public Health, 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, at its own discretion,

request any additional information it deems necessary for the

evaluation of the application.

(1) Any health care professional who performs a Point-

of-Care Rapid Test for COVID-19 shall be required to report the

results and personal information of all tests carried out to the

Superintendence of Public Health for each operation using the COVID

Rapid Testing Malta.

(2) Any health care professional who performs a Point-of-Care

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

Rapid Antigen for SARS-CoV-2 issued by the Superintendence for

Public Health under article 4(c) of the Public Health Act.

(1) The Authority may, where it so deems necessary,

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

health 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 performed in Malta.

In the advertising of COVID-19 Test Kit, it shall be Advertising.

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

other signs that may mislead the user or the patient with regard to the

device's intended purpose, safety and performance.

(1) Nothing in these regulations shall prejudice the Data protection.

applicability of the Regulation and the Data Protection Act and the Cap. 586.

fundamental rights and freedoms of the data subjects.

(2) Where the Superintendent in his capacity of a controller

processes personal data through the COVID Rapid Testing Malta for

reasons of public interest in the area of public health pursuant to

Articles 6(1)(e) and 9(2)(i) of the Regulations, he shall

(a) comply with the principles relating to the processing

of personal data pursuant to Article 5(1) of the Regulation;

(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 patients, including the information in relation to the test performed

on the patient for the purposes of these regulations, for a period of (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 the Regulation in relation

to any personal data processed by the controller.

Whenever, after assessing the circumstances surrounding Decommission

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

application.

COVID Rapid Testing Malta is no longer necessary, the

Superintendent shall

(a)

decommission the COVID Rapid Testing Malta;

(b)

cease to process any data under these regulations;

(c) publish instructions for the uninstallation of the

COVID Rapid Testing Malta.

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.

€0.45