1. A model for the future conduct of pharmacovigilance;Waller;Pharmacoepidemiol Drug Saf,2003
2. European Union Legislation - Eudralex Volume 9A of The Rules Governing Medicinal Products in the European Union 2008 http://ec.europa.eu/health/files/eudralex/vol-9/pdf/vol9a_09-2008_en.pdf
3. Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 amending, as regards pharmacovigilance 74 99 http://ec.europa.eu/health/files/eudralex/vol-1/dir_2010_84/dir_2010_84_en.pdf
4. 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 http://ec.europa.eu/health/files/eudralex/vol-1/reg_2010_1235/reg_2010_1235_en.pdf
5. Criteria for evaluating evidence on public health intervention;Rychetnik;J Epidemiol Community Health,2002