Article 4 Requirements for the performance of studies for applications submitted under Articles 5(3) and 17(3)
United Kingdom
Toxicological studies shall be conducted in facilities which comply with the:
requirements of Directive 2004/10/EC; or
‘OECD Principles on Good Laboratory Practice’ (GLP), if carried out outside F1Great Britain.
The applicant shall provide evidence to demonstrate such compliance.
Studies, other than toxicological studies, shall:
comply with the principles of Good Laboratory Practice (GLP) laid down in Directive 2004/10/EC; or
be conducted by organisations accredited under the relevant ISO standard.
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.
Annotations
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)