Dáil Éireann Debate, Tuesday - 13 January 2026
2137. Deputy Cormac Devlin asked the Minister for Health the PSI’s enforcement actions other than fitness-to-practise sanctions; the number of warning/advisory letters, undertakings, any District Court proceedings, and any other formal compliance actions; and the basis on which such actions are deployed for each year 2020 to date in 2025; and if she will make a statement on the matter. [74205/25]
Amharc ar fhreagraI thank the Deputy for the question. My Department has engaged with the Pharmaceutical Society of Ireland (PSI) and they have submitted the information below in response to the question.
The Registrar considers significant issues identified during an inspection or an investigation under Section 71 of the Pharmacy Act 2007. This is a function designated to the Registrar by the Council. The Registrar has a number of options available including; to take no action [under Section 71(1)(a)], to commence disciplinary proceedings/make a formal complaint [under Section 71(1)(b)], or to take such other actions [under Section 71(1)(d)] as the Registrar considers appropriate in the circumstances.
The number of actions/decisions taken by the Registrar under Section 71 of the Act are reported in the PSI's annual report. In 2020, the Registrar exercised the legislative authority on a total of 13 occasions, 7 in 2021, 11 in 2022, 2 in 2023, 2 in 2024 and 1 in 2025.
Actions taken by the Registrar under Section 71(1)(d) of the Pharmacy Act 2007 include but are not limited to re-inspection, requesting voluntary undertakings, enforcement letters, meeting with those in governance positions, referring an authorised officer’s report to another body, initiating summary legal proceedings/prosecution, or requesting the Council of the PSI to formally consider making an application to the High Court seeking an Order pursuant to section 45 of the Pharmacy Act 2007 suspending a pharmacist’s or a pharmacy’s registration pending further procedures under Part 6 the Pharmacy Act 2007.
