1. Council Directive 96/29/Euratom of 13 May 1996 laying down basic safety standards for the protection of the health of workers and the general public against the dangers arising from ionizing radiation.
2. Council Directive 97/43/Euratom of 30 June 1997 on health protection of individuals against the dangers of ionizing radiation in relation to medical exposure, and repealing Directive 84/466/Euratom.
3. Day 80 assessment report – non-clinical guidance. .
4. Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use.
5. Environmental risk assessments for medicinal products containing, or consisting of, genetically modified organisms (GMOs) (module 1.6.2) (EMEA/CHMP/BWP/135148/2004).