Commercialisation of GM medicinal products: Tools for risk assessment and risk management

The European Medicines Agency (EMA) has published several scientific guidelines to help applicants prepare marketing-authorisation applications for human medicines and veterinary medicines. These guidelines also serve as supporting tools for the scientific assessment of the regulatory dossiers by the Biosafety Council, the SBB and their external experts.
Particularly in relation to GMO medicinal products the following guidelines (non-exhaustive list) can be of interest (links to the EMA website):

The Biosafety and Biotechnology Unit (SBB) also issued scientific publications that are relevant to the safety assessment of GMO medicinal products, in particular: