1. Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products. Official Journal of the European Union L 348/1, 31/12/2010.
2. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use. Official Journal of the European Union L 348/74, 31/12/2010.
3. EudraLex [Homepage]. Volume 9A guidelines on pharmacovigilance for medicinal products for human use. In: The rules governing medicinal products in the European Union. 2007. http://ec.europa.eu . Accessed 1 Jul 2013.
4. EMA/838713/2011. Guideline on good pharmacovigilance practices (GVP). Module V: risk management systems. 2012. http://www.ema.europa.eu . Accessed 1 Jul 2013.
5. Amendments to the pharmacovigilance legislation: new notification requirements for marketing-authorisation holders. 2013. http://www.ema.europa.eu . Accessed 1 Jul 2013.