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2. Commission of the European Communities, Regulation of the european parliament and of the council amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Communityprocedures for the authorisation and supervision of medicinal products for humanand veterinary use and establishing a European Medicines Agency, URL: https://ec.europa.eu/health/sites/health/files/files/pharmacos/pharmpack_12_2008/pharmacovigilance-ia-vol1_en.pdf
3. European Medicines Agency, 2016 Annual Report on EudraVigilance for the European Parliament, the Council and the Commission, London, 2017, p. 1-33.
4. U.S. Department of Health and Human Services, Food and Drug Administration, FDA Adverse Event Reporting System (FAERS) Public Dashboard, URL: http://www.fda.gov/Drugs/GuidanceComplianceRegulatoryInformation/Surveillance/AdverseDrugEffects/ucm070093.htm
5. Invima, Informe programa nacional de farmacovigilancia enero-febrero 2016, Farma Seguridad, 5(1), 9-13 (2016).