Medicines and Medical Devices Act 2021

46 Reporting requirements

(1) As soon as reasonably practicable after the end of each reporting period, the relevant authority must lay before the appropriate legislature a report on the operation of any regulations made by the relevant authority under sections 2(1), 10(1), 15(1) and 19(1) that were in force at any time during the reporting period.

(2) In preparing a report, the relevant authority must consult such persons as the relevant authority considers appropriate.

(3) A report must include a summary of—

(a) any concerns raised, or proposals for change made, by a person consulted in accordance with subsection (2), and

(b) the relevant authority’s response to those concerns or proposals, including any plan the relevant authority may have to make further regulations under section 2(1), 10(1), 15(1) or 19(1).

(4) The reporting periods are—

(a) the period of 24 months beginning with the day on which the first set of regulations under section 2(1), 10(1), 15(1) or 19(1) comes into force, and

(b) each successive period of 24 months.

(5) In this section—

• “appropriate legislature” means—

  (a)

  in relation to a report of the Secretary of State, Parliament;

  (b)

  in relation to a report of a Northern Ireland department, the Northern Ireland Assembly;

• “relevant authority” means—

  (a)

  in relation to regulations made under section 2(1) or 10(1) by the Secretary of State (whether acting alone or jointly with a Northern Ireland department), the Secretary of State;

  (b)

  in relation to regulations made under section 2(1) or 10(1) by a Northern Ireland department (whether acting alone or jointly with the Secretary of State), the Northern Ireland department;

  (c)

  in relation to regulations made under section 15(1) or 19(1), the Secretary of State.