Client/ Distributor PVAs
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Discussion around what you would consider as Day 0 for a case if the arrangement was such that you sell to a distributor and then they sell further to the end customer (HCPs). Would you consider Day 0 as the day when they report to Medical Information as opposed to when they receive the information from HCPs/patients?
Specific information is given in the Guideline on good pharmacovigilance practices (GVP) Module VI – Collection, management and submission of reports of suspected
adverse reactions to medicinal products (Rev 2) , section VI.B.7. Submission of individual case safety reports (ICSRs).
The main challenge is when a major international non-MAH organisation is distributing further medicinal products to smaller national/regional distributors, including sole HCP (pharmacist) distributors in some countries. MAHs should have PVAs with all these distributors. Other HCPs are not contractors.