The Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002

Exempt activities S

15.— [F1 (1)] The cases and circumstances prescribed for the purposes of [F2 section] 111(7) of the Act in which persons are exempt from the requirements of F3 ... section 111(1)(a) of the Act (to obtain consent) F4 ... insofar as [F5 it relates] to marketing genetically modified organisms, are all cases and circumstances in which–

(a) an approved product [F6 , which is permitted to be marketed in Scotland in pursuance of an authorisation under the Food and Feed Regulation,] is marketed for a use for which it has approval [F7 and in accordance with the limitations [F8 , conditions and restrictions] to which [F9 that use of the] product is subject];

[F10 (aa) a pre-exit approved product is marketed during the relevant period—

(i) for a use (other than cultivation in Scotland) for which it had marketing consent in accordance with the Deliberate Release Directive or the 1990 Directive immediately before exit day and for which it continues to have consent for that use in Scotland, and

(ii) in accordance with the limitations and conditions to which that use of the product was subject immediately before exit day, as may be modified by virtue of these Regulations or the Act,]

(b) genetically modified micro-organisms are made available for activities regulated under [F11 the Genetically Modified Organisms (Contained Use) Regulations 2014] (including culture collections);

F12 (c) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

(d) genetically modified organisms are made available to be used exclusively for deliberate releases complying with the requirements laid down in Part II; [F13 and]

[F14 (e) a genetically modified organism is marketed which is, or is contained in, a medicinal product authorised under—

(i) the Human Medicines Regulations 2012, or

(ii) the Veterinary Medicines Regulations 2013.]

F15 (f) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

F16 (g) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

[F17 (2) For the purposes of paragraph (1), “the relevant period”, in relation to a pre-exit approved product, means the period beginning with exit day and ending with the day which immediately precedes the day on which the consent concerned ceases to be valid.]

Textual Amendments

F1 Reg. 15 renumbered as reg. 15(1) (15.3.2019) by The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 7(a)

F2 Word in reg. 15(1) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(5)(a)

F3 Words in reg. 15(1) omitted (28.3.2019) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(5)(b)(i)

F4 Word in reg. 15(1) omitted (28.3.2019) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(5)(b)(ii)

F5 Words in reg. 15(1) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(5)(c)

F6 Words in reg. 15(1)(a) inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(6)(a)(i); 2020 c. 1, Sch. 5 para. 1(1)

F7 Words in reg. 15(a) added (15.11.2004) by The Genetically Modified Organisms (Deliberate Release) (Scotland) Amendment Regulations 2004 (S.S.I. 2004/439), regs. 1, 4(a)

F8 Words in reg. 15(1)(a) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(5)(d)(i)

F9 Words in reg. 15(1)(a) substituted (28.3.2019) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(a), 2(5)(d)(ii)

F10 Reg. 15(1)(aa) inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(6)(a)(ii); 2020 c. 1, Sch. 5 para. 1(1)

F11 Words in reg. 15(1)(b) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(6)(a)(iii); 2020 c. 1, Sch. 5 para. 1(1)

F12 Reg. 15(1)(c) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(6)(a)(iv); 2020 c. 1, Sch. 5 para. 1(1)

F13 Word in reg. 15(1)(d) inserted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(6)(a)(v); 2020 c. 1, Sch. 5 para. 1(1)

F14 Reg. 15(1)(e) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(6)(a)(vi); 2020 c. 1, Sch. 5 para. 1(1)

F15 Reg. 15(1)(f) and word omitted (15.3.2019) by virtue of The Genetically Modified Organisms (Deliberate Release etc.) (Miscellaneous Amendments) (Scotland) Regulations 2019 (S.S.I. 2019/86), regs. 1(1), 7(d)

F16 Reg. 15(1)(g) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(6)(a)(vii); 2020 c. 1, Sch. 5 para. 1(1)

F17 Reg. 15(2) substituted (31.12.2020) by The Genetically Modified Organisms (EU Exit) (Scotland) (Amendment) Regulations 2019 (S.S.I. 2019/57), regs. 1(2)(b), 3(6)(b); 2020 c. 1, Sch. 5 para. 1(1)