C16

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

F38[32G.—(1) Where the Minister, having consulted with the Health Service Executive and the Health Products Regulatory Authority, is of the opinion that—

(a) there is a medicinal product shortage,

(b) arising from that shortage, there is likely to be a negative impact on the health service or the health needs of patients that cannot be addressed via other mechanisms, and

(c) a protocol under this section would assist in addressing the impacts referred to in paragraph (b),

he or she may prepare and issue a protocol to registered pharmacists authorising registered pharmacists to supply such alternative medicinal product or products as are specified in the protocol for the medicinal product that is in short supply under such conditions as are specified in the protocol and without the need for a further prescription.

(2) In the preparation and issuing of a protocol under this section, the Minister shall act in accordance with regulations made under section 32H and shall consult with the bodies referred to in subsection (1) in relation to the content of the protocol.

(3) A protocol prepared and issued under this section shall specify—

(a) the medicinal product that is in short supply,

(b) the substitutable product,

(c) the circumstances in which the registered pharmacist may supply the substitutable product,

(d) the time period for which the protocol is in place, and

(e) such other conditions or information in respect of the supply by a registered pharmacist of the substitutable medicinal product as the Minister considers appropriate.

(4) The Minister may, where appropriate and following consultation with the Health Products Regulatory Authority and the Health Service Executive, amend the time period during which the protocol is in place or any conditions specified in the protocol.

(5) The Minister shall publish or cause to be published each protocol issued (or amended) under this section in such form and manner, including on a website maintained by or on behalf of the Minister, as the Minister considers appropriate.]