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Published on 25 May 2012

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EMA clarifies new pharmacovigilance legislation

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The European Medicines Agency has published a set of questions and answers concerning the initial phases of the operation of the pharmacovigilance legislation.

The document, published today, clarifies some practical considerations that pharmaceutical companies will need to take into account before and after the legislation starts to apply in July this year. 

It includes the agreed position of the European Union (EU) regulatory network, following discussions between the Agency, national regulatory authorities and the European Commission services.

The document includes answers to frequently asked questions on the following topics:

  • Good pharmacovigilance practice guidelines;
  • Pharmacovigilance system master files and summary of the pharmacovigilance system;
  • Risk management plans;
  • Post-authorisation safety studies;
  • Periodic safety update reports and EU reference date list;
  • Literature monitoring;
  • Product information and the black symbol;
  • Adverse-drug-reaction reporting and signal management;
  • Renewals.

The Agency will update the question-and-answer document on a regular basis.

European Medicines Agency



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