Health and Social Care Act 2012

57 Functions in relation to biological substances

(1) The appropriate authority must—

(a) devise standards for the purity and potency of biological substances,

(b) prepare, approve, hold and distribute standard preparations of biological substances,

(c) design appropriate procedures for testing biological substances,

(d) provide or arrange for the provision of laboratory facilities for testing biological substances,

(e) carry out tests on biological substances,

(f) examine records kept in connection with the manufacture and quality control of biological substances,

(g) report on the results of tests or examinations conducted in pursuance of paragraph (e) or (f), and

(h) carry out or arrange for the carrying out of such research, or provide or arrange for the provision of such information or training, as it considers appropriate in connection with the functions mentioned in paragraphs (a) to (g).

(2) The appropriate authority may do anything which it considers is appropriate for facilitating, or incidental or conducive to, the exercise of any of its functions under this section.

(3) Subsections (4) and (5) apply to any person that exercises functions similar to those of the appropriate authority under this section (whether or not in relation to the United Kingdom).

(4) The appropriate authority must co-operate with the person in the exercise of those functions.

(5) The person must co-operate with the appropriate authority in the exercise of the authority’s functions under this section.

(6) The appropriate authority may make charges (whether or not on a commercial basis) in respect of anything done by it under this section.

(7) Any function conferred on the appropriate authority by this section may be performed by either the Secretary of State or the Department of Health, Social Services and Public Safety in Northern Ireland acting alone or both of them acting jointly (and references in this section to the appropriate authority are to be construed accordingly).

(8) In this section “biological substance” means a substance whose purity or potency cannot, in the opinion of the Secretary of State, be adequately tested by chemical means.