C18

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

F40[32I.—(1) The Health Products Regulatory Authority may require a relevant person to provide to the Authority, in such form and manner and within such period as may be prescribed by regulations made by the Minister, such information in relation to medicinal products within the possession or control of the relevant person as the Authority considers necessary for the purpose of the management of the availability of medicinal products in the State, including—

(a) the monitoring of the current and future supply of medicinal products, and

(b) the identification and management of medicinal product shortages.

(2) A relevant person shall comply with a requirement set out in regulations made under subsection (1).

(3) In this section, "relevant person" means the following persons involved in the manufacture or supply of a medicinal product:

(a) the holder of a manufacturer’s authorisation granted under Regulation 8 of the Medicinal Products (Control of Manufacture) Regulations 2007 (S.I. No. 539 of 2007);

(b) the holder of a marketing authorisation granted in accordance with the Medicinal Products (Control of Placing on the Market) Regulations 2007;

(c) the holder of a community marketing authorisation within the meaning of the Medicinal Products (Control of Placing on the Market) Regulations 2007;

(d) the holder of a wholesaler’s authorisation granted under Regulation 9 of the Medicinal Products (Control of Wholesale Distribution) Regulations 2007 (S.I. No. 538 of 2007);

(e) a retail pharmacy business within the meaning of the Pharmacy Act 2007;

(f) a hospital;

(g) such other persons or legal entities, being persons or entities authorised or entitled to supply medicinal products, as may be prescribed in regulations made by the Minister.]