CHAPTER III U.K. SPECIFIC REQUIREMENTS

Article 4 U.K. Requirements for the performance of studies for applications submitted under Articles 5(3) and 17(3)

1. Toxicological studies shall be conducted in facilities which comply with the:

(a) requirements of Directive 2004/10/EC; or

(b) ‘OECD Principles on Good Laboratory Practice’ (GLP), if carried out outside [F1 Great Britain].

The applicant shall provide evidence to demonstrate such compliance.

2. Studies, other than toxicological studies, shall:

(a) comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC; or

(b) be conducted by organisations accredited under the relevant ISO standard.

3. Information on the study protocols and the results obtained from the studies referred to in paragraphs 1 and 2 shall be comprehensive and include the raw data in an electronic format, suitable for carrying out statistical or other analysis.

Textual Amendments

F1 Words in Art. 4(1)(b) substituted (31.12.2020) by by The Genetically Modified Food and Feed (Amendment etc.) (EU Exit) Regulations 2019 (S.I. 2019/705), regs. 1, 49 (as substituted by S.I. 2020/1504, regs. 1(2), 17(9)); 2020 c. 1, Sch. 5 para. 1(1)