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New rules on pharmacovigilance in Europe: more of the same?

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References

  1. EU Pharmacovigilance Rules for Human and Veterinary Medicinal Products, Version December 2001, http://pharmacos.eudra.org/F2/eudralex/vol-9/pdf/Vol9en.pdf.

  2. EMEA website at http://www.emea.eu.int/.

  3. Notice to Marketing Authorization Holders: Pharmacovigilance Guidelines. CPMP/ PhVWP/108/99, January 1999.

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Authors
  1. Elliot Brown
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Additional information

Dr Brown is a consultant to several pharmaceutical companies, to some regulatory authorities and the World Health Organization. He was involved in the preparation of the 1999 Notice to Marketing Authorization Holders as a (former) member of the CPMP Pharmacovigilance Working Party.

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Brown, E. New rules on pharmacovigilance in Europe: more of the same?. International Journal of Pharmaceutical Medicine 16, 3–4 (2002). https://doi.org/10.2165/00124363-200202000-00003

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  • DOI: https://doi.org/10.2165/00124363-200202000-00003

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