The Human Medicines Regulations 2012

[F1 Applications in relation to medicinal products containing or consisting of genetically modified organisms U.K.

50J.— (1) This regulation applies in relation to an application for a UK marketing authorisation for a relevant medicinal product which contains or consists of genetically modified organisms.

(2) The applicant for a UK marketing authorisation to which this regulation applies must, in addition to the material specified in regulation 50, provide to the licensing authority—

(a) a copy of the consent to the deliberate release into the environment of the genetically modified organisms for research and development purposes given pursuant to—

(i) regulation 21 of the Genetically Modified Organisms (Deliberate Release) Regulations 2002,

(ii) regulation 22 of the Genetically Modified Organisms (Deliberate Release) (Wales) Regulations 2002,

(iii) regulation 21 of the Genetically Modified Organisms (Deliberate Release) (Scotland) Regulations 2002, or

(iv) regulation 21 of the Genetically Modified Organisms (Deliberate Release) Regulations (Northern Ireland) 2003;

(b) a complete technical dossier supplying the information specified in Annexes III and IV to Directive 2001/18/EC;

(c) an environmental risk assessment in accordance with the principles set out in Annex II to Directive 2001/18/EC; and

(d) the results of any investigations performed for the purposes of research or development.

(3) In this regulation, “genetically modified organism” has the meaning given in Article 2(2) of Directive 2001/18/EC.]

Textual Amendments

F1 Regs. 50A-50J inserted (31.12.2020) by The Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/775), regs. 1, 53 (as amended by S.I. 2020/1488, reg. 1, Sch. 2 para. 40(a)-(g)); 2020 c. 1, Sch. 5 para. 1(1)