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J Pharmacol Pharmacother. 2013 Dec;4(Suppl 1):S33-7. doi: 10.4103/0976-500X.120945.

Pharmacovigilance in pharmaceutical companies: An overview.

Author information

1
Department of Science of Health, School of Medicine, University of Catanzaro and Pharmacovigilance's Centre Calabria Region, University Hospital Mater Domini, Catanzaro, Italy.

Abstract

Pharmacovigilance is responsible for monitoring the safety of medicines in normal clinical use and during clinical trials. In the light of the experience acquired and following an assessment by the Commission of the Union system of pharmacovigilance, it has become clear that it is necessary to take measures in order to improve the operation of Union law on the pharmacovigilance of medicinal products for human use. Regulation (EU) No 1235/2010 and Directive 2010/84/EU introduced new legislation on pharmacovigilance. The marketing authorization holder should be responsible for continuously monitoring the safety of its medicinal products for human use, for informing the authorities of any changes that might have an impact on the marketing authorization, and for ensuring that the product information is kept up-to-date. Marketing authorization holders (MAH) record all suspected adverse reactions occurring in the European Union or in the third countries, and which are brought to their attention spontaneously by the patients or their health care, or occurring in the context of post-authorization study. For all medicinal products is mandatory to maintain a pharmacovigilance system master file (PSMF). According to the Legislative Decree 219/2006 the MAH must submit to the competent authorities the information on suspected adverse reactions of a medicinal product, in form of a periodic safety update reports (PSURs).

KEYWORDS:

Italy; pharmaceutical companies; pharmacovigilance; regulation

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