CHAPTER IIISPECIFIC REQUIREMENTS
Article 4Requirements 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 F1Great 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.