Wholesale Distribution of Medicinal Products for Human Use
With certain exceptions, distributors of human medicines are required to hold a wholesaler’s authorisation. To obtain an authorisation to distribute medicinal product compliance with the principles of Good Distribution Practice (GDP) must be demonstrated.
“Good Distribution Practice (GDP) is that part of quality assurance which ensures that products are consistently stored, transported and handled under suitable condition as required by the marketing authorisation (MA) or product specification and that traceability is ensured.”
To verify that the appropriate systems are in place inspectors monitor compliance with the GDP principles through regular on-site inspections.