S.L. 458.61 ст. 8Issuance of approval.

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.