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Guideline on good pharmacovigilance practices (GVP)

Guideline on good pharmacovigilance practices (GVP)

www.ema.europa.eu

Guideline on good pharmacovigilance practices (GVP) – Module VI (Rev 2) EMA/873138/2011 Rev 2 Page 3/144 VI.C.2. Collection of individual safety reports ..... 31