Denmark clears Europharma to sell drugs after reinspection
The DKMA lifted the suspension on March 13, explaining the wholesaler had corrected problems that saw the agency suspend its distribution license and suggest it dismiss its CEO in January.
The regulator said: “With the help of advisers within good manufacturing practice for GMP, the company has worked professionally to correct all the deficiencies the Danish Medicines Agency identified at its last inspection in December 2016.”
The lifting of the suspension follows just a few weeks after Europharma hired Abacus Medicines to repackage and distribute pharmaceutical products on its behalf.
Re-inspection
The DKMA re-inspected Europharma’s manufacturing facility and warehouse in Esbjerg, southwest Denmark on March 8.
The agency said although its inspectors identified a number of new minor deficiencies during the visit, Europharma had corrected the major problems observed during the previous inspection.
The DKMA also reassessed Europharma’s drug stocks, which were quarantined during the suspension period.
Thomas Vestergaard Pedersen, Team Manager of the Danish Medicines Agency's inspection, said: “The company has worked hard and professionally to regain its authorisation and has shown strong will to change its past culture.
“It is against this background that we have handed back their authorisation to manufacture medicinal products.”
