Part 2Amendment to Part 1 (Introductory Provisions)

Amendment to regulation 2

regulation 3 + 3.—(1) Regulation 2 (interpretation) is amended as follows.

(2) In paragraph (1)—

regulation 3 2 a + (a)in the definition of “adverse event” for “subject” substitute “participant”;

regulation 3 2 b + (b)in the definition of “adverse reaction” for “subject”, in both places where it occurs, substitute “participant”;

regulation 3 2 c + (c)omit the definition of “authorised health professional”;

regulation 3 2 d + (d)after the definition of “assemble” insert—

““the Authority” is to be construed in accordance with regulation 5(3);”;

regulation 3 2 e + (e)in the definition of “business” for “Schedule 2” substitute “regulation 9”;

regulation 3 2 f + (f)for the definition of “chief investigator”(1) substitute—

““chief investigator” means—

regulation 3 2 g + (g)in the definition of “clinical trial” for “subjects” substitute “participants”;

regulation 3 2 h + (h)after the definition of “clinical trial” insert—

““Commission Delegated Regulation 2017/1569”, other than in Parts 2 and 3 of Schedule 7, means, in the case of an investigational medicinal product manufactured or assembled in, or imported into, Northern Ireland, Commission Delegated Regulation (EU) 2017/1569 of 23 May 2017 supplementing Regulation (EU) No 536/2014 of the European Parliament and of the Council by specifying principles of and the guidelines for good manufacturing practice for investigational medicinal products for human use and arrangements for inspections, as that Regulation has effect in EU law(2);”;

regulation 3 2 i + (i)in the definition of “Commission Directive 2003/94/EC”(3) omit paragraph (b);

regulation 3 2 j + (j)in paragraph (a) of the definition of “conducting a clinical trial” for “subject” substitute “participant”;

regulation 3 2 k + (k)omit the definition of “the Directive”(4);

regulation 3 2 l + (l)in the definition of “ethics committee”—

regulation 3 2 l i + (i)in paragraph (a)—

regulation 3 2 l i aa + (aa)omit “or recognised”;

regulation 3 2 l i bb + (bb)insert “or” at the end;

regulation 3 2 l ii + (ii)in paragraph (b)—

regulation 3 2 l ii aa + (aa)for “the Ethics Committee” substitute “an Ethics Committee”;

regulation 3 2 l ii bb + (bb)at the end, omit for “, or”;

regulation 3 2 l iii + (iii)omit paragraph (c);

regulation 3 2 m + (m)after the definition of “ethics committee” insert—

““the EU Regulation” means Regulation 536/2014 of the European Parliament and of the Council of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC, as that Regulation has effect in EU law(5);”;

regulation 3 2 n + (n)omit the definition of “the Gene Therapy Advisory Committee”(6);

regulation 3 2 o + (o)omit the definition of “Health and Social Services Board”;

regulation 3 2 p + (p)in the definition of “health care professional”—

regulation 3 2 p i + (i)in paragraph (c), for “nurse” substitute “registered nurse as defined in regulation 8(1) of the 2012 Regulations”;

regulation 3 2 p ii + (ii)in paragraph (f)(7), for “a register established and maintained under article 5 of” substitute “the Health and Care Professions Council register (as defined in regulation 8(1) of the 2012 Regulations) as a member of a relevant profession within the meaning of article 2 of, and paragraph 1 of Schedule 3 to, the”;

regulation 3 2 p iii + (iii)in paragraph (h), at the end, omit “or”;

regulation 3 2 p iv + (iv)in paragraph (i), at the end, insert “or”;

regulation 3 2 p v + (v)after paragraph (i) insert—

“(j)a registered midwife as defined in regulation 8(1) of the 2012 Regulations;”;

regulation 3 2 q + (q)in the definition of “health centre” for “section 2 or 3 of the National Health Service Act 1977” substitute “section 2 or 3 of the National Health Service Act 2006(8), section 2 or 3 of the National Health Service (Wales) Act 2006(9)”;

regulation 3 2 r + (r)in the definition of “health service body”—

regulation 3 2 r i + (i)in paragraph (a)(10) for “Health and Social Services Board” substitute “the Department of Health in Northern Ireland”;

regulation 3 2 r ii + (ii)for paragraph (g) substitute—

“(g)the Regional Business Services Organisation for the health and social care in Northern Ireland established under the Health and Social Care (Reform) Act (Northern Ireland) 2009,”;

regulation 3 2 s + (s)in the definition of “insurance or indemnity” for paragraph (b)(iv) substitute—

“(iv)the Department of Health in Northern Ireland,”;

regulation 3 2 t + (t)in the definition of “investigational medicinal product dossier”—

regulation 3 2 t i + (i)for “authorisation” substitute “approval”;

regulation 3 2 t ii + (ii)for “paragraph 11” substitute “paragraph 5(b)”;

regulation 3 2 u + (u)for the definition of “investigator” substitute—

““investigator” means, in relation to a clinical trial, the health care professional who is responsible for the conduct of that trial at that trial location or, if more than one, the trial locations; and who is, if the trial is conducted by a team of health care professionals at that location or locations, the leader responsible for that team;”;

regulation 3 2 v + (v)in the definition of “investigator’s brochure” for “subjects” substitute “participants”;

regulation 3 2 w + (w)in the definition of “legal representative” omit “Parts 2 to 4 of”;

regulation 3 2 x + (x)after the definition “non-interventional trial” insert—

““non-investigational medicinal product” means a medicinal product used or to be used in a clinical trial, as described in the protocol, but not as an investigational medicinal product;

“notifiable trial” has the meaning given in regulation 11A;

“participant” means, in relation to a clinical trial, an individual, whether a patient or not, who participates in a clinical trial—

regulation 3 2 y + (y)omit the definition of “nurse”;

regulation 3 2 z + (z)in the definition of “Phase I trial” for “subjects” substitute “participants”;

regulation 3 2 z1 + (z1)in the definition of “the principles and guidelines of good manufacturing practice”, after “Commission Directive 2003/94/EC” insert “in respect of Great Britain or Commission Delegated Regulation 2017/1569 in respect of Northern Ireland”;

regulation 3 2 z2 + (z2)in paragraph (a) of the definition of “qualified person” for “Article 49 or 50 of Directive 2001/83” substitute “Schedule 7 to the 2012 Regulations”;

regulation 3 2 z3 + (z3)after the definition of “qualified person” insert—

““radiopharmaceutical” has the same meaning as in regulation 8(1) of the 2012 Regulations;”;

regulation 3 2 z4 + (z4)in the definition of “relevant ethics committee”—

regulation 3 2 z4 i + (i)in paragraph (a)—

regulation 3 2 z4 i aa + (aa)for “paragraph 13 of Schedule 2” substitute “regulation 6(3)”;

regulation 3 2 z4 i bb + (bb)for “sub-paragraph (5) of that paragraph” substitute “regulation 6(3)(b)”;

regulation 3 2 z4 ii + (ii)in paragraph (b)—

regulation 3 2 z4 ii aa + (aa)for “an appeal panel” substitute “another ethics committee”;

regulation 3 2 z4 ii bb + (bb)omit “paragraph 4(4) of”;

regulation 3 2 z4 ii cc + (cc)for “that committee” substitute “the ethics committee which has given the favourable opinion”;

regulation 3 2 z5 + (z5)omit the definition of “Strategic Health Authority”;

regulation 3 2 z6 + (z6)omit the definition of “subject”;

regulation 3 2 z7 + (z7)for the definition of “trial site” substitute—

““trial location” means a hospital, health centre, surgery or other establishment, or facility or premises at or from which a clinical trial, or any part of such a trial, is conducted;”.

Amendment to regulation 3

regulation 4 + 4.—(1) Regulation 3 (sponsor of a clinical trial) is amended as follows.

(2) In paragraphs (4) and (5)—

regulation 4 2 a + (a)for “request for authorisation”, in both places where it occurs, substitute “request for approval”;

regulation 4 2 b + (b)for “regulation 17”, in both places where it occurs, substitute “regulation 16”.

(3) In paragraph (6)—

regulation 4 3 a + (a)for “authorised by the licensing authority” substitute “approved”;

regulation 4 3 b + (b)for “, 19 or 20” substitute “or 18A”;

regulation 4 3 c + (c)for “substantial amendment” substitute “modification of an important detail as defined in Part 3”;

regulation 4 3 d + (d)for “authorisation” substitute “approval”;

regulation 4 3 e + (e)for “regulations 24 to 26” substitute “regulation 22”.

(4) In paragraph (7)—

regulation 4 4 a + (a)in sub-paragraph (a), omit “, except regulation 15”;

regulation 4 4 b + (b)in sub-paragraph (b), omit “Parts 2 to 4 of”;

regulation 4 4 c + (c)in sub-paragraph (c), omit “, in so far as it relates to decisions of the licensing authority under Part 3”.

(5) In paragraph (10)—

regulation 4 5 a + (a)in sub-paragraph (a), for “regulations 15 and 28(1)” substitute “regulation 28(1)”;

regulation 4 5 b + (b)in sub-paragraph (c), omit “, and Part 1 of Schedule 3”.

Insertion of new regulation 3B

regulation 5 + 5.  After regulation 3A (sponsor’s responsibility for the investigator’s brochure) insert—

Investigator in a clinical trial

3B.  The investigator, in relation to a clinical trial, shall be a health care professional who is appropriately trained to undertake that role in a clinical trial.”.