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Psur Repository

Found 2 free book(s)

Guideline on good pharmacovigilance practices (GVP)

www.ema.europa.eu

PSUR EU regional appendix, sub-section “Summary of ongoing safety concerns” 58 VII.C.5.4. PSUR EU regional appendix, sub-section “Reporting of results from post-

  Spur

Pharmacovigilance Risk Assessment Committee (PRAC)

www.ema.europa.eu

Jan 14, 2021 · Pharmacovigilance Risk Assessment Committee (PRAC) EMA/PRAC/532676/2021 Page 5/114 8. Renewals of the marketing authorisation, conditional renewal and

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