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EudraVigilance (EV)

Pharmacovigilance

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What are the benefits of the EudraVigilance Gateway?

The benefits of the Gateway implementation can be summarised as follows:

  • Standardisation of secure data transmission between the EMA, Competent Authorities, MAHs. applicants and sponsors in the EEA.
  • Elimination of data transcription errors.
  • Acceleration of the communication for expedited safety reporting.
  • Reduction of the paper processing burden/cost for Competent Authorities, MAH, applicants and sponsors in the EEA.
  • Compliance with international standards and open technology solutions.

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Last update: Monday, 29 May 2006.

 

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