References

References

1. EMA Guideline on good pharmacovigilance practices (GVP) Module XV – Safety communication. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2013/01/WC500137666.pdf

2. EMA Guideline on Good pharmacovigilance Practices (GVP) - Annex II – Templates: Direct Healthcare Professional Communication (DHPC). https://www.ema.europa.eu/en/documents/template-form/guideline-good-pharmacovigilance-practices-annex-ii-templates-direct-healthcare-professional_en.pdf

3. Dutch Medicines Evaluation Board on DHPCs. http://english.cbg-meb.nl/

4. Zeitoun JD, Lefevre JH, Downing N, Bergeron H, Ross JS: Inconsistencies among European Union pharmaceutical regulator safety communications: a cross-country comparison. PloS one 9(10), e109100 (2014). http://journals.plos.org/plosone/article?id=10.1371/journal.pone.0109100