EMA published Draft Guidance on Medication Errors for Public Consultation
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EMA published Draft Guidance on Medication Errors for Public Consultation

08/05/2015

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Ireland

The European Medicines Agency (EMA) published three draft guidance documents concerning medication errors for consultation on 14 April 2015.New EU laws and regulations governing pharmacovigiliance activities require reports of suspected adverse reactions arising from an error associated with the use of a medical product to be reported to EudraVigilance.The draft guidance documents are as follows:Good practice guide on recording, coding, reporting and assessment of medicati...

The European Medicines Agency (EMA) published three draft guidance documents concerning medication errors for consultation on 14 April 2015.

New EU laws and regulations governing pharmacovigiliance activities require reports of suspected adverse reactions arising from an error associated with the use of a medical product to be reported to EudraVigilance.

The draft guidance documents are as follows:

  1. Good practice guide on recording, coding, reporting and assessment of medication errors
  2. Good practice guide on risk minimisation and prevention of medication errors
  3. Risk minimisation strategy for high strength and fixed combination insulin products, addendum to the good practice guide on risk minimisation and prevention of medication errors