Безопасность и риск фармакотерапии (Feb 2018)

Typical pharmacovigilance system master file (PSMF)

  • B. K. Romanov,
  • R. N. Alyautdin,
  • S. V. Glagolev,
  • V. A. Polivanov

Journal volume & issue
Vol. 0, no. 2
pp. 11 – 27

Abstract

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The typical pharmacovigilance system master file (PSMF) is presented. MPSF was created on the basis of the Rules of good pharmacovigilance practice for the members of Eurasian economic Union countries. Possible ways of the description of the pharmacovigilance system, all the possible types of MPSP and constituent standard operating procedures are considered. Practical recommendations on preparation and using of MFSF are given.

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