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