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Reactions 1446 - 6 Apr 2013 The EMA is to begin conducting periodic safety update reports (PSURs) on active substances for all medicines authorised in more than one Member State. Until now, the Agency has only been assessing PSURs for centrally authorised medicines. From 1 April 2013, it will start carrying out single assessments of PSURs of active substances contained in centrally authorised medicines alone, as well as those found in medicines authorised both centrally and nationally. Active substances found only in nationally authorised medicines will also be subject to a centralised assessment beyond 2013. The aim of conducting these single assessments of PSURs is to harmonise and strengthen the safety and benefit-risk review of medicines across the EU Member States. EMA. European Medicines Agency to begin PSUR assessment based on active substances in both centrally and nationally authorised medicines. Internet Document : 27 Mar 2013. Available from: URL: http:// www.ema.europa.eu 803085355 1 Reactions 6 Apr 2013 No. 1446 0114-9954/10/1446-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved

EMA to conduct PSURs of nationally authorised meds

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Reactions 1446 - 6 Apr 2013

■ The EMA is to begin conducting periodic safetyupdate reports (PSURs) on active substances for allmedicines authorised in more than one Member State.Until now, the Agency has only been assessing PSURsfor centrally authorised medicines. From 1 April 2013,it will start carrying out single assessments of PSURsof active substances contained in centrally authorisedmedicines alone, as well as those found in medicinesauthorised both centrally and nationally. Activesubstances found only in nationally authorisedmedicines will also be subject to a centralisedassessment beyond 2013. The aim of conducting thesesingle assessments of PSURs is to harmonise andstrengthen the safety and benefit-risk review ofmedicines across the EU Member States.EMA. European Medicines Agency to begin PSUR assessment based on activesubstances in both centrally and nationally authorised medicines. InternetDocument : 27 Mar 2013. Available from: URL: http://www.ema.europa.eu 803085355

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Reactions 6 Apr 2013 No. 14460114-9954/10/1446-0001/$14.95 Adis © 2010 Springer International Publishing AG. All rights reserved