PART 6 U.K. Report on operation of medicines and medical devices legislation

48 Report on operation of medicines and medical devices legislation U.K.

(1) The Secretary of State must, before the end of the relevant period, publish a report on the operation of medicines and medical devices legislation.

(2) The report must, in particular, include an assessment of whether—

(a) some or all medicines and medical devices legislation should be consolidated or otherwise restructured,

(b) provisions of medicines and medical devices legislation should be included in regulations or Acts of Parliament, and

(c) powers to make regulations should be modified or repealed.

(3) In preparing the report, the Secretary of State must take into account any report relating to the operation of medicines and medical devices legislation made by a Parliamentary Committee.

(4) The Secretary of State must lay a copy of the report before Parliament.

(5) In this section—

• “medicines and medical devices legislation” means—

  (a)

  the law relating to human medicines within the meaning of section 9 (interpretation);

  (b)

  the Veterinary Medicines Regulations 2013 (S.I. 2013/2033);

  (c)

  the Medical Devices Regulations 2002 (S.I. 2002/618);

  (d)

  Parts 2 to 5 of this Act;

  (e)

  regulations made under those Parts;

• “Parliamentary Committee” means a committee of the House of Commons or of the House of Lords or a joint committee of both Houses;

• “relevant period” means the period of 5 years beginning with the day on which this Act is passed.