The Adjustment to the Pharmacovigilance law requires a considerable investment especially for SME (small-medium Enterprises).This occurs for two reasons:
1. The SME are not big enough to justify the costs for development “in house” of all necessary expertise to operate in the highly complicated and regulated pharmaceutical sectorbranch.
2.Adjustment to the Pharmacovigilance law requires fixed investments regardless of the number and types of products. Therefore the management of few ADR warnings per year still requires enormous investment.
|
