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Transparency Directive: Amendments proposed in the EP Health Committee (ENVI)

Saturday, November 10th, 2012 in News

The amendments which are proposed in the Health Committee of the European Parliament (ENVI) regarding the Commission proposal on the review of the Transparency Directive 89/105/EEC are available here (Rapporteur), here (AM 43-133) and here (AM 134-278). The ENVI will vote on these amendments on 18.12.2012.

New PV legislation published: Directive 2012/26/EU + Regulation 1027/2012

Thursday, November 8th, 2012 in News

On 27 October 2012 the new Pharmacovigilance Directive 2012/26/EU (amending Directive 2001/83/EC) and on 14 November 2012 the new Pharmacovigilance Regulation (EU) No 1027/2012 (amending Regulation 726/2004) were published in the Official Journal of the European Union. The Directive enters into force on 16 November 2012. Member States must transpose ... read more...

EMA Regulatory Workshop on Medication Errors

Thursday, October 11th, 2012 in News

The European Medicines Agency will host a workshop on medication errors with regards to the new EU pharmacovigilance legislation on 28 February – 1 March 2013. The workshop aims at bringing together stakeholders involved in the prevention, reporting and evaluation of medication errors. Topics addressed will be: 1. Clarification and common understanding ... read more...