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; 2010. http://ec.europa.eu/health/files/eudralex/vol-1/reg_2010_1235/reg_2010_1235_en.pdf . Accessed 21 Oct 2013.
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; 2010. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF . Accessed 21 Oct 2013.
3. 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—article 107a. Official Journal L. 2004;311:67–128.
4. World Health Organization website. http://apps.who.int/medicinedocs/fr/d/Jh1465e/4.html . Accessed 20 Sept 2013.
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