101 Medicine information systems

101  Medicine information systems

(1)     The Medicines and Medical Devices Act 2021 is amended in accordance with subsections (2) to (9).

(2)     In Part 2, for the heading of Chapter 1 substitute “Regulations: general”.

(3)     After that Chapter insert—

“Chapter 1A
Regulations: Information Systems

7A Information systems

(1)     The appropriate authority may by regulations make provision about the establishment and operation by the Health and Social Care Information Centre (“the Information Centre”) of one or more information systems for purposes relating to—

(a)     the safety of human medicines, including the safety of clinical decisions relating to human medicines;

(b)     the quality and efficacy of human medicines.

(2)     The regulations may (among other things) make provision—

(a)     about the information in relation to human medicines which may or must be entered or retained in an information system established under subsection (1);

(b)     requiring information to be provided to the Information Centre for the purposes of its functions under the regulations;

(c)     about the use or disclosure of information contained in an information system established under subsection (1);

(d)     requiring the Information Centre to have regard to specified matters in exercising its functions under the regulations.

(3)     The provision mentioned

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