1. EMA. European Medicines Agency Webpage providing information on risk-management plans (RMPs), including guidance to marketing-authorisation holders on submitting RMPs to the European Medicines Agency. http://www.ema.europa.eu/ema/index.jsp?curl=pages/regulation/document_listing/document_listing_000360.jsp&mid=WC0b01ac058067a113. Published 2015. Accessed March 2015.
2. EC. Volume 9A of the rules governing medicinal products in the European Union—guidelines on pharmacovigilance for medicinal products for human use. Final, September 2008 [Now Supersed ed]. Published 2008.
3. EMA. Guideline on good pharmacovigilance practices (GVP) Module V—Risk management systems (Rev 1). EMA/838713/2011 Rev 1, 15 April 2014. http://www.ema.europa.eu/docs/en_GB/document_library/Scientific_guideline/2012/06/WC500129134.pdf. Published 2014.
4. EMA. Guidance on format of the risk management plan (RMP) in the EU part II: Module SII—Non-clinical part of the safety specification. EMA/465926/2013 Rev 1, 25 July 2013. http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2012/11/WC500134654.pdf. Published 2013.
5. EMEA. Annex C: Template for EU risk management plan (EU-RMP). EMEA/192632/2006, 27 September 2006. http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2009/10/WC500006317.pdf. Published 2006.