S.L. 458.62 · Authorisation For Preparation And (S.L. 458.62)
S.L. 458.62 Art. 4Application for authorisation. 2 [S.L.
(1) The Central Procurement and Supplies Unit
(CPSU) may present its application in writing to the Authority requesting authorisation to prepare and dispense medicinal products by automated means.
(2) The application shall include:
(a) the name and address of applicant; OF MEDICINAL PRODUCTS BY AUTOMATED MEANS FROM DESIGNATED PREMISES AT CENTRAL 458.62 PROCUREMENT AND SUPPLIES UNIT (CPSU)
(b) the address of the premises that is to be used for such purpose, which shall be the designated premises;
(c) the equipment and control facilities;
(d) information, documentation or evidence to prove that the premises are suitable and adequate, and that there are suitable facilities, installations and equipment so as to ensure proper preparation, conservation and dispensing of the medicinal products, as well as cross contamination and mix-up prevention;
(e) the name and address of a managing pharmacist, registered with the Pharmacy Council; and
(f) any other information, documentation or evidence as may be requested by the Authority.