1. European Parliament and Council. Directive 2004/27/EC of The European Parliament and of the Council of 31 March 2004, amending Directive 2001/83/EC on the Community Code relating to medicinal products for human use. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2004_27/dir_2004_27_en.pdf . Accessed 1 Aug 2017.
2. European Commission. 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. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0074:0099:EN:PDF . Accessed 1 Aug 2017.
3. European Commission. 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. Available at: http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2010:348:0001:0016:EN:PDF . Accessed 1 Aug 2017.
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5. European Medicines Agency. Guideline on good pharmacovigilance practices (GVP): Module V—Risk management systems2017 (Rev 2). Available at: http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf . Accessed 1 Aug 2017.