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15.—[F1(1)] The cases and circumstances prescribed for the purposes of sections 108(7) and 111(7) of the Act in which persons are exempt from the requirements of section 108(1)(a) of the Act (to carry out a risk assessment) and of section 111(1)(a) of the Act (to obtain consent), respectively, insofar as they relate to marketing genetically modified organisms, are all cases and circumstances in which—
(a)an approved product is marketed for a use for which it has approval [F2and in accordance with the limitations and conditions to which the use of that product is subject],
[F3(aa)a pre-exit approved product is marketed during the relevant period for a use for which it had approval before exit day and in accordance with the limitations and conditions to which the use of that product was subject before exit day,]
[F4(b)genetically modified organisms are made available for activities regulated under the Genetically Modified Organisms (Contained Use) Regulations 2014;]
(d)genetically modified organisms are made available to be used exclusively for deliberate releases complying with the requirements laid down in Part II,
[F5(e)a genetically modified organism is marketed which is contained in a medicinal product authorised under the Human Medicines Regulations 2012 or the Veterinary Medicines Regulations 2013 ;]
F6(f). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
F7(g). . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
[F8(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 on the day on which the consent concerned ceases to be valid.]
Textual Amendments
F1Reg. 15 renumbered as reg. 15(1) (31.12.2020) by The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(5)(a); 2020 c. 1, Sch. 5 para. 1(1)
F2Words in reg. 15(a) inserted (8.10.2004) by The Genetically Modified Organisms (Deliberate Release) (Amendment) Regulations 2004 (S.I. 2004/2411), regs. 1, 2(3)(a)
F3Reg. 15(1)(aa) inserted (31.12.2020) by The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(5)(b); 2020 c. 1, Sch. 5 para. 1(1)
F4Reg. 15(1)(b) substituted for reg. 15(1)(b)(c) (31.12.2020) by The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(5)(c); 2020 c. 1, Sch. 5 para. 1(1)
F5Reg. 15(1)(e) substituted (31.12.2020) by The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(5)(d); 2020 c. 1, Sch. 5 para. 1(1)
F6Reg. 15(f) omitted (13.2.2019) by virtue of The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(a), 2(2)(b)
F7Reg. 15(1)(g) omitted (31.12.2020) by virtue of The Genetically Modified Organisms (Amendment) (England) (EU Exit) Regulations 2019 (S.I. 2019/88), regs. 1(2)(b), 3(5)(e); 2020 c. 1, Sch. 5 para. 1(1)
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