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

Amendment to regulation 49

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

(2) In paragraph (1)(1)—

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.”.