1. 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 as amended;EC;Off J Eur Comm,2001
2. Regulation (EC) No. 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency;EC;Off J Eur Comm,2004
3. EC 2008a Volume 9A of the Rules Governing Medicinal Products in the European Union http://ec.europa.eu/health/documents/eudralex/vol-9/index_en.htm
4. Commission Regulation (EC) No. 1234/2008 of 24 November 2008 concerning the examination of variations to the terms of a marketing authorisation for medicinal products for human use and veterinary medicinal products;EC;Off J Eur Comm,2008b