Abstract
With the European legislation for pharmacovigilance, a number of new requirements for the monitoring of the safety of medicinal products were introduced in 2012. This change of the legislation of human medicines in the European Union was the biggest change for about 17 years. It was the result of a review of the European safety monitoring system for human medicinal products, which led to changes of the existing legislation concerning pharmacovigilance and to their adoption.
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References
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use amended by Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010 (OJ L 348, 31.12.2010, p. 74)
Regulation (EC) No 726/2004 of the European Parliament and of the Council of 31 March 2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency amended by Regulation (EU) No 1235/2010 of the European Parliament and of the Council of 15 December 2010 (OJ L 348, 31.12.2010, p. 1)
Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities provided for in Regulation (EC) No 726/2004 of the European Parliament and of the Council and Directive 2001/83/EC of the European Parliament and of the Council (OJ L 159, 20.06.2012, p. 5)
Guideline on good pharmacovigilance practices (GVP) Module V – Risk management systems (Rev 1); EMA/838713/2011 Rev 1 (2014)
Guideline on good pharmacovigilance practices (GVP) Module VII – Periodic safety update report (Rev 1); EMA/816292/2011 Rev 1 (2013)
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Storz, E. (2017). Impact of Referral Procedures on the Interaction of RMP and PSUR. In: Edwards, I., Lindquist, M. (eds) Pharmacovigilance. Adis, Cham. https://doi.org/10.1007/978-3-319-40400-4_16
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DOI: https://doi.org/10.1007/978-3-319-40400-4_16
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