C17

Prospective affecting provision: section inserted by Health (Miscellaneous Provisions) Act 2024 (23/2024), s. 10, not commenced as of date of revision.

F39[32H.—(1) The Minister shall make regulations providing for the issuing and operation of a protocol.

(2) Without prejudice to the generality of subsection (1), such regulations shall include—

(a) the procedures for the preparation and review of a protocol including in relation to—

(i) the assessment of the impact of the medicinal product shortage on the provision of a health service and the health needs of patients,

(ii) the assessment of existing mechanisms to address the negative impacts of a medicinal product shortage, including the availability of appropriate alternatives,

(iii) the identification of a substitutable medicinal product and any conditions that should apply in accordance with its supply, and

(iv) the persons who shall be consulted in relation to the preparation and review,

(b) the procedure for the notification of a protocol (including any amendment made to the protocol) to registered pharmacists,

(c) the procedure for the operation of a protocol, and

(d) the requirements in relation to the notification of the supply of a substitutable medicinal product under a protocol to the person who prescribed the medicinal product that is in short supply.]