Denmark withdraws Europharma’s GMP certification... again
It has been a turbulent year for Danish pharmaceutical parallel import, repacking and distribution firm Europharma DK ApS.
In January the DKMA partly suspended Europharma’s manufacturing authorisation and withdrew its good manufacturing practices (GMP) certification following an inspection prompted by a whistleblower at the site in Esbjerg.
Two months later the company was issued a new GMP certificate, clearing it to resume drug sales and distribution after the firm appointed a new managing director.
But an inspection in September has now led to this GMP certificate being withdrawn, and Europharma is once again banned from undertaking manufacturing activities or re-packing medicinal products.
The DKMA put this down to “a general lack of will and ability to adhere to the principles of good manufacturing and good distribution practices,” in a statement of non-compliance published on the EudraGMDP website. Examples given by the Danish regulators include:
“QP not present in company for supervision and competent interaction with staff and management as agreed with our Agency, QA department understaffed, Inadequate follow-up and implementation of corrective and preventive actions from previous inspection, Insufficient handling of deviations and complaints, Inadequate control for falsifications and temperature excursions during transportation upon receipt of medicinal products, Deficient procedures for qualification of transporters/forwarders.”
According to its website, Europharma imports drugs from EU countries which it repackages and sells in Denmark, Germany and Sweden.
The firm – which employs 44 people – claims to have a portfolio of “500 active products” and to generate annual revenue of €100m ($105m).
