Part 10Amendment to Part 8 (Enforcement and Related Provisions)

Amendment to regulation 48

regulation 33 + 33.  In regulation 48 (infringement notices), for paragraph (4)(1) substitute—

“(4) This regulation applies to regulations 3A, 12(1) and (2), 13(1), 22(2) to (5), 25(1) and (2)(a), 27, 28(1) to (3), 29, 29A, 30(2), 31A to 35, 36(1), 36A, 36B, 42, 43(1) and (6), 45A, 46 and 46A.”.

Amendment to regulation 49

regulation 34 + 34.—(1) Regulation 49 (offences) is amended as follows.

(2) In paragraph (1)(2)—

regulation 34 2 a + (a)after sub-paragraph (b) insert—

“(ba)regulation 22(2) to (5);

(bb)regulation 25(1) and (2)(a);

(bc)regulation 26(7)(a);”;

regulation 34 2 b + (b)after sub-paragraph (ff) insert—

“(fg)regulation A32;”;

regulation 34 2 c + (c)in sub-paragraph (l), at the end, omit “and”;

regulation 34 2 d + (d)in sub-paragraph (m), for “(6),” substitute “(6); and”;

regulation 34 2 e + (e)after sub-paragraph (m), insert—

“(n)regulation 45A,”.

(3) In paragraphs (6) and (7), in each place where it occurs, for “subject” substitute “participant”.

(4) After paragraph (7) insert—

“(8) Any sponsor who sells or supplies, or procures the sale or supply of, a non- investigational medicinal product—

(a)to a participant for the purposes of a clinical trial; or

(b)to a person for the purpose of administering the product to such a participant,

the labelling of which does not comply with regulation 46A, shall be guilty of an offence.

(9) Any person who sells or supplies, or procures the sale or supply of, a non-investigational medicinal product—

(a)to a participant for the purposes of a clinical trial; or

(b)to a person for the purpose of administering the product to such a participant,

the labelling of which does not comply with regulation 46A, knowing, or having reasonable cause to believe, that the labelling does not so comply, shall be guilty of an offence.”.

Amendment to regulation 50

regulation 35 + 35.  In regulation 50 (false or misleading information), in paragraph (1)—

regulation 35 a + (a)in sub-paragraph (b), at the end, omit “or”;

regulation 35 b + (b)after sub-paragraph (c) insert—

“(d)notifying a modification of an important detail; or

(e)making a modification request,”.