Pharmacovigilance

  • Medicines under additional monitoring

    EMA/244682/2013

    Download pdf file (78KB)

  • EC Regulation on implementation of the Pharmacovigilance legislation published in the OJEU

    The Commission Implementing Regulation (EU) No 520/2012 of 19 June 2012 on the performance of pharmacovigilance activities was published in the Official Journal (20.6.2012) of the European Union

  • Amended process for electronic reporting of adverse reactions to the National Organization for Medicines (EOF)

    The English translation of the Greek original announcement regarding the new electronic reporting requirements for Greece.

    Ref. No: 67585(260911)

     

    Related Docs (available only in Greek):

    Ref. No: 36043(290507)

    Ref. No: 89219(141209)

  • Directive 2010/84/EU of the European Parliament and of the Council of 15 December 2010

    amending, as regards pharmacovigilance, Directive 2001/83/EC on the Community code relating to medicinal products for human use

  • Regulation 1235/2010 of the EU Parliament and the Council of 15 Dec 2010

    amending, as regards pharmacovigilance of medicinal products for human use, Regulation (EC) No 726/2004 laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Medicines Agency, and Regulation (EC) No 1394/2007 on advanced therapy medicinal products

  • The rules governing Medicinal Products in the European Union Volume 10 - Guidance Documents applying to Clinical Trials

    QUESTIONS & ANSWERS SPECIFIC TO ADVERSE REACTION REPORTING IN CLINICAL TRIALS
    VERSION 1.0 (DECEMBER 2009)

    Brussels, 03 Dec 2009
    ENTR/F/2/SF/dn D(2009) 40108

  • PhVWP and CMD(h) Best Practice Guide for Work Sharing concerning the assessment of PSURs of products for which an EU harmonised virtual birth date and related harmonised data lock point have been agreed

    Version, 10 November 2009

  • Guidance Document for Marketing Authorisation Holders on submissions of PSURs under the EU PSUR work sharing scheme

    Version 10 November 2009

  • “Pharmacovigilance and Public Health: The Stakeholders and their contribution to the safe use of medicines”

    Round Table ΣfΕΕ

  • VOLUME 9 - PHARMACOVIGILANCE Medicinal Products for Human Use and Veterinary Medicinal Products

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