- 'Procedures for marketing authorisation', the Rules governing Medicinal Products in the European Community, Notice to Applicants, Volume 2A, Chapter 1
- Guidance on elements required to support the significant clinical benefit in comparison with existing therapies of a new therapeutic indication in order to benefit from an extended (11 years) marketing protection period
- Guidance on new therapeutic indication for a well-established substance
- Guideline on changing the classification for the supply of a medicinal product for human use