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.