The Controlled Drugs (Supervision of Management and Use) Regulations (Northern Ireland) 2009

[^key-92679d3488c6846d6b2332f228206ebe]: Reg. 25(6)(aa) inserted (16.7.2015) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 (S.R. 2015/278), regs. 1(1), 16

[^key-d0b3b0e806d8c38a8a7d15e78513c336]: Words in reg. 25(6)(a) substituted (16.7.2015) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 (S.R. 2015/278), regs. 1(1), 20(a)

[^key-acc423fd4ce27865a54422a04d91e627]: Words in reg. 25(7) substituted (16.7.2015) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 (S.R. 2015/278), regs. 1(1), 20(a)

[^key-5ee81ec0aa69a2cf406e4586c02fdae4]: Words in reg. 26(5)(a) substituted (16.7.2015) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 (S.R. 2015/278), regs. 1(1), 20(b)

[^key-c40592703dd3d9366c448eecdf1bbbac]: Words in reg. 26(6) substituted (16.7.2015) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 (S.R. 2015/278), regs. 1(1), 20(b)

[^key-dd55ced41913e38de826995c262cdcff]: Reg. 26(5)(ba) inserted (16.7.2015) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 (S.R. 2015/278), regs. 1(1), 17

[^key-5a613cf375b12326edeabac941c3edd8]: Reg. 29(1) substituted (16.7.2015) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 (S.R. 2015/278), regs. 1(1), 18

[^key-b0a046ffb734732864cffbfb872f2eb2]: Words in reg. 29(3) substituted (16.7.2015) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 (S.R. 2015/278), regs. 1(1), 20(c)

[^key-a6307752d1562bcdd1c7c4247801b865]: Reg. 30 substituted (16.7.2015) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 (S.R. 2015/278), regs. 1(1), 19

[^key-2935cbac6fe5c23b3b549a176274a68f]: Words in reg. 31 substituted (16.7.2015) by The Controlled Drugs (Supervision of Management and Use) (Amendment) Regulations (Northern Ireland) 2015 (S.R. 2015/278), regs. 1(1), 21

[^key-8a2e80a9b30d23803707976366174e43]: Words in reg. 25(7) inserted (25.5.2018) by Data Protection Act 2018 (c. 12), s. 212(1), Sch. 19 para. 347(2) (with ss. 117, 209, 210); S.I. 2018/625, reg. 2(1)(g)

[^key-76e765a75e88cd236d05785953485778]: Reg. 25(8) substituted (25.5.2018) by Data Protection Act 2018 (c. 12), s. 212(1), Sch. 19 para. 347(3) (with ss. 117, 209, 210); S.I. 2018/625, reg. 2(1)(g)

[^key-e312ac127ed70037e8f407653dcc6bf9]: Words in reg. 26(6) inserted (25.5.2018) by Data Protection Act 2018 (c. 12), s. 212(1), Sch. 19 para. 348(2) (with ss. 117, 209, 210); S.I. 2018/625, reg. 2(1)(g)

[^key-579b185860ea83d5e4cc7eebbf76d9f6]: Reg. 26(7) substituted (25.5.2018) by Data Protection Act 2018 (c. 12), s. 212(1), Sch. 19 para. 348(3) (with ss. 117, 209, 210); S.I. 2018/625, reg. 2(1)(g)

[^key-d4979fb8a571d57df58d3934f11cecba]: Words in reg. 29(3) inserted (25.5.2018) by Data Protection Act 2018 (c. 12), s. 212(1), Sch. 19 para. 349(2) (with ss. 117, 209, 210); S.I. 2018/625, reg. 2(1)(g)

[^key-9c33e641478332c126ddbf8f9264382a]: Reg. 29(4) substituted (25.5.2018) by Data Protection Act 2018 (c. 12), s. 212(1), Sch. 19 para. 349(3) (with ss. 117, 209, 210); S.I. 2018/625, reg. 2(1)(g)

[^key-2a57f6077fb0ccdf9884f70667985967]: Words in reg. 2(2) omitted (31.12.2020) by virtue of The Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019 (S.I. 2019/419), reg. 1(2), Sch. 3 para. 80(a) (with Sch. 3 para. 112); 2020 c. 1, Sch. 5 para. 1(1)

[^key-cad1ca1b5ca30e950d9a8f5360ef67d4]: Words in reg. 2(2) inserted (31.12.2020) by The Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019 (S.I. 2019/419), reg. 1(2), Sch. 3 para. 80(b) (with Sch. 3 para. 112); 2020 c. 1, Sch. 5 para. 1(1)

[^key-202d941abe1b9e4d4709d66de4ac8706]: Words in reg. 25(7) substituted (31.12.2020) by The Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019 (S.I. 2019/419), reg. 1(2), Sch. 3 para. 81 (with Sch. 3 para. 112); 2020 c. 1, Sch. 5 para. 1(1)

[^key-cb3287957505e5707557f3e78b7d37ac]: Words in reg. 26(6) substituted (31.12.2020) by The Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019 (S.I. 2019/419), reg. 1(2), Sch. 3 para. 82 (with Sch. 3 para. 112); 2020 c. 1, Sch. 5 para. 1(1)

[^key-deba83e1bab9756a3a689f98bded0445]: Words in reg. 29(3) substituted (31.12.2020) by The Data Protection, Privacy and Electronic Communications (Amendments etc) (EU Exit) Regulations 2019 (S.I. 2019/419), reg. 1(2), Sch. 3 para. 83 (with Sch. 3 para. 112); 2020 c. 1, Sch. 5 para. 1(1)

Meaning of “relevant independent hospital”

2A

• (1) For the purposes of these Regulations, “relevant independent hospital” means an independent hospital which the Department has determined satisfies the conditions set out in paragraph (2).

• (2) The conditions are—

• (a) the independent hospital is directly or indirectly concerned with the provision of health care; and

• (b) management or use of controlled drugs forms part of the activities of the independent hospital; and

• (c) requiring that independent hospital to appoint or nominate an accountable officer would not give rise to difficulties that would be disproportionate to the benefits to be derived from such an appointment or nomination, having regard to—

• (i) the usual number of relevant individuals who work at the independent hospital;

• (ii) the usual level of relevant activities at or provided from the independent hospital; and

• (iii) any difficulties there may be in identifying a suitable individual to act as an accountable officer for that independent hospital, taking into account the size of the business being carried on at or from the independent hospital and any possibility of a joint appointment or nomination by that independent hospital together with other independent hospitals.

• (3) A determination under paragraph (1) is to be notified to the independent hospital and is for such duration as the Department specifies, but the determination may thereafter be—

• (a) renewed for such further period as the Department specifies; or

• (b) rescinded, after the Department has given the independent hospital to which the determination relates reasonable notice of the rescission.

• (4) A refusal of a determination under paragraph (1), renewal or refusal to renew under paragraph (3)(a) or rescission under paragraph (3)(b) must be notified to the independent hospital.

• (5) Where, in respect of an independent hospital, the Department—

• (a) makes a determination, or decides to refuse a determination, under paragraph (1);

• (b) renews or refuses to renew a determination under paragraph (3)(a); or

• (c) rescinds a determination under paragraph (3)(b),

that independent hospital may request a review of that determination, refusal, renewal or rescission as the case may be.

• (6) A request under paragraph (5) must be made in writing within a period of 28 days beginning with the date of the determination, refusal, renewal or rescission as the case may be.

• (7) Where an independent hospital has requested such a review under paragraph (5), the Department may ask that independent hospital to furnish such additional information as it thinks fit.

• (8) The accountable officer of a relevant independent hospital shall inform the Department of any change in its circumstances which is likely to affect the conditions set out in paragraph (2).

Appointment of and support for accountable officers

List of accountable officers

6A

• (1) Each designated body shall as soon as is practicable notify the Department in writing of—

• (a) any nomination or appointment by it of an accountable officer, or

• (b) the removal from office by it of an accountable officer.

• (2) Where the nomination or appointment of an accountable officer, or removal from office of an accountable officer, is by a group of designated bodies, notification under paragraph (1) may be undertaken by the designated body or undertaking of which the accountable officer is or was an employee or officer, on behalf of the group.

• (3) The Department shall compile, maintain and publish from time to time, and in such manner as it sees fit, a list of accountable officers of designated bodies in Northern Ireland.

Funds and other resources available to accountable officers

Accountable officers to have regard to best practice

Accountable officers to secure the safe management and use of controlled drugs

Accountable officers to ensure adequate destruction and disposal arrangements for controlled drugs

Accountable officers to ensure monitoring and auditing of the management and use of controlled drugs by designated bodies etc.

Powers to require declarations and self-assessments, as part of accountable officers’ monitoring and auditing arrangements or otherwise

Accountable officers to ensure relevant individuals receive appropriate training etc.

Accountable officers to monitor and audit the management and use of controlled drug by relevant individuals, and to monitor and assess their performance

Accountable officers to maintain a record of concerns regarding relevant individuals

Accountable officers to assess and investigate concerns

Accountable officers to take appropriate action if there are well-founded concerns

Arrangements for sharing information