Testing of COVID-19 (Amendment) Regulations, 2022

Suppliment tal-Gazzetta tal-Gvern ta’ Malta Nru. 20,831, 11 ta’ April, 2022 B 621

L.N. 118 of 2022

MEDICINES ACT

(CAP. 458)

Testing of COVID-19 (Amendment) Regulations, 2022

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 is the Testing of COVID-19 Citation.

(Amendment) Regulations, 2022 and these regulations shall be read

and construed as one with the Testing of COVID-19 Regulations, S.L. 458.61.

hereinafter referred to as the "principal regulations".

Regulation 2 of the principal regulations shall be amended Amends

regulation 2 of

as follows

the principal

regulations.

(a) the definition "Point-of-Care Test for COVID-19"

shall be substituted by the following new definition

" "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;"; and

(b) the definition "rapid antigen test" or "RAT" shall be

substituted by the following new definition

" "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;".

The proviso to sub-regulation (1) of regulation 3 of the Amends

principal regulations shall be substituted by the following new regulation

the principal

regulations.

"Provided that regulation 9 shall not apply to

antibody tests and devices for self-testing.".

Regulation 8 of the principal regulations shall be

substituted by the following new regulation

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.".

5. Regulation 10 of the principal regulations shall be

substituted by the following new regulation

"10. 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.".

€0.09